Trial Outcomes & Findings for Trial to Evaluate the Safety and Immunogenicity of a Modified Vaccinia Ankara (MVA)-Based Anti-Cytomegalovirus (CMV) Vaccine (Triplex®) (NCT NCT05099965)
NCT ID: NCT05099965
Last Updated: 2026-05-14
Results Overview
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Higher scores/grades mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
From Day 0 through Week 48
Results posted on
2026-05-14
Participant Flow
Participants enrolled from 13 US-based sites during the recruitment period of November 2021 to December 2023.
Participant milestones
| Measure |
CMV-MVA Triplex
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
31
|
|
Overall Study
COMPLETED
|
54
|
24
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
CMV-MVA Triplex
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Missed Dosing Window
|
1
|
1
|
|
Overall Study
Participant in Long-Term Care Facility
|
1
|
0
|
|
Overall Study
Found to Not Meet Eligibility Criteria After Randomization
|
1
|
0
|
Baseline Characteristics
Participants with quantifiable HIV-1 RNA results at baseline.
Baseline characteristics by cohort
| Measure |
CMV-MVA Triplex
n=61 Participants
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 Participants
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=61 Participants
|
50 years
n=29 Participants
|
54 years
n=90 Participants
|
|
Age, Customized
18-29 years
|
3 Participants
n=61 Participants
|
2 Participants
n=29 Participants
|
5 Participants
n=90 Participants
|
|
Age, Customized
30-39 years
|
6 Participants
n=61 Participants
|
6 Participants
n=29 Participants
|
12 Participants
n=90 Participants
|
|
Age, Customized
40-49 years
|
9 Participants
n=61 Participants
|
5 Participants
n=29 Participants
|
14 Participants
n=90 Participants
|
|
Age, Customized
50-65 years
|
43 Participants
n=61 Participants
|
16 Participants
n=29 Participants
|
59 Participants
n=90 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=61 Participants
|
6 Participants
n=29 Participants
|
22 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=61 Participants
|
23 Participants
n=29 Participants
|
68 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=61 Participants
|
4 Participants
n=29 Participants
|
14 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=61 Participants
|
25 Participants
n=29 Participants
|
76 Participants
n=90 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=61 Participants
|
9 Participants
n=29 Participants
|
30 Participants
n=90 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=61 Participants
|
20 Participants
n=29 Participants
|
55 Participants
n=90 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=90 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
3 Participants
n=90 Participants
|
|
Sex and Hormone Use Stratification Factor
Female not on testosterone or male on feminizing hormone
|
16 Participants
n=61 Participants
|
7 Participants
n=29 Participants
|
23 Participants
n=90 Participants
|
|
Sex and Hormone Use Stratification Factor
Female on testosterone or male not on feminizing hormone
|
45 Participants
n=61 Participants
|
22 Participants
n=29 Participants
|
67 Participants
n=90 Participants
|
|
Weight
|
83.9 kg
n=61 Participants
|
89.8 kg
n=29 Participants
|
85.2 kg
n=90 Participants
|
|
Body Mass Index
|
26.9 kg/m^2
n=61 Participants
|
28.4 kg/m^2
n=29 Participants
|
27.3 kg/m^2
n=90 Participants
|
|
Body Mass Index Category
Normal (18.5-24.9)
|
18 Participants
n=61 Participants
|
8 Participants
n=29 Participants
|
26 Participants
n=90 Participants
|
|
Body Mass Index Category
Overweight (25-29.9)
|
25 Participants
n=61 Participants
|
10 Participants
n=29 Participants
|
35 Participants
n=90 Participants
|
|
Body Mass Index Category
Obese (≥30)
|
18 Participants
n=61 Participants
|
11 Participants
n=29 Participants
|
29 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
100-200 cells/mm3
|
13 Participants
n=61 Participants
|
5 Participants
n=29 Participants
|
18 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
201-350 cells/mm^3
|
22 Participants
n=61 Participants
|
11 Participants
n=29 Participants
|
33 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
351-500 cells/mm^3
|
11 Participants
n=61 Participants
|
7 Participants
n=29 Participants
|
18 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
501-650 cells/mm^3
|
11 Participants
n=61 Participants
|
5 Participants
n=29 Participants
|
16 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
651-800 cells/mm^3
|
2 Participants
n=61 Participants
|
1 Participants
n=29 Participants
|
3 Participants
n=90 Participants
|
|
Nadir CD4 Count Category
800+ cells/mm^3
|
2 Participants
n=61 Participants
|
0 Participants
n=29 Participants
|
2 Participants
n=90 Participants
|
|
CD4 Count
|
783 cells/mm^3
n=61 Participants
|
746 cells/mm^3
n=29 Participants
|
782 cells/mm^3
n=90 Participants
|
|
HIV-1 RNA
<50 copies/mL
|
59 Participants
n=61 Participants
|
26 Participants
n=29 Participants
|
85 Participants
n=90 Participants
|
|
HIV-1 RNA
≥50 copies/mL
|
2 Participants
n=61 Participants
|
3 Participants
n=29 Participants
|
5 Participants
n=90 Participants
|
|
HIV-1 RNA Category
<Lower Limit of Quantification
|
56 Participants
n=61 Participants
|
22 Participants
n=29 Participants
|
78 Participants
n=90 Participants
|
|
HIV-1 RNA Category
≥Lower Limit of Quantification
|
5 Participants
n=61 Participants
|
7 Participants
n=29 Participants
|
12 Participants
n=90 Participants
|
|
HIV-1 RNA
|
1.58 log10 copies/mL
n=5 Participants • Participants with quantifiable HIV-1 RNA results at baseline.
|
1.60 log10 copies/mL
n=7 Participants • Participants with quantifiable HIV-1 RNA results at baseline.
|
1.59 log10 copies/mL
n=12 Participants • Participants with quantifiable HIV-1 RNA results at baseline.
|
|
Hemoglobin
|
14.4 g/dL
n=61 Participants
|
15.0 g/dL
n=29 Participants
|
14.5 g/dL
n=90 Participants
|
|
Platelet Count
|
253000 platelets/mm^3
n=61 Participants
|
217000 platelets/mm^3
n=29 Participants
|
243500 platelets/mm^3
n=90 Participants
|
|
Hemoglobin A1C
|
5.4 %
n=61 Participants
|
5.5 %
n=29 Participants
|
5.4 %
n=90 Participants
|
|
Soluble Tumor Necrosis Factor Receptor Type II
|
2562 pg/mL
n=57 Participants • Baseline sTNFRII summary statistics were only calculated for participants in the per-protocol (PP) population. The PP population was limited to participants who 1) received the Day 0 CMV-MVA Triplex®/placebo injection, 2) did not use prohibited medications from Day 0 until the Week 48 visit, and 3) did not have a confirmed virologic failure prior to Week 48.
|
2702 pg/mL
n=29 Participants • Baseline sTNFRII summary statistics were only calculated for participants in the per-protocol (PP) population. The PP population was limited to participants who 1) received the Day 0 CMV-MVA Triplex®/placebo injection, 2) did not use prohibited medications from Day 0 until the Week 48 visit, and 3) did not have a confirmed virologic failure prior to Week 48.
|
2603 pg/mL
n=86 Participants • Baseline sTNFRII summary statistics were only calculated for participants in the per-protocol (PP) population. The PP population was limited to participants who 1) received the Day 0 CMV-MVA Triplex®/placebo injection, 2) did not use prohibited medications from Day 0 until the Week 48 visit, and 3) did not have a confirmed virologic failure prior to Week 48.
|
PRIMARY outcome
Timeframe: From Day 0 through Week 48Population: Modified intent-to-treat (mITT) Population: All participants who initiated study treatment (received at least one injection of study treatment)
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Higher scores/grades mean a worse outcome.
Outcome measures
| Measure |
CMV-MVA Triplex
n=61 Participants
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 Participants
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Occurrence of Grade ≥3 AEs
|
14 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Measured at Day 0 and Week 48Population: Per-protocol (PP) population: All participants who 1) received the Day 0 CMV-MVA Triplex®/placebo injection, 2) did not use prohibited medications from Day 0 until the Week 48 visit, and 3) did not have a confirmed virologic failure prior to Week 48.
The absolute change in sTNFRII at Week 48 is the value at Week 48 minus the value at baseline (Day 0). Linear regression was used to estimate the mean change by treatment arm adjusted for the sex and hormone use stratification factor.
Outcome measures
| Measure |
CMV-MVA Triplex
n=57 Participants
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 Participants
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Change in sTNFRII
|
170.1 pg/mL
Interval -13.6 to 353.8
|
-60.9 pg/mL
Interval -318.2 to 196.3
|
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 24, 48 and 72The absolute change in IL-6 refers to the value at the follow-up time point minus the value at baseline (Day 0). The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 24, 48, 72The absolute change in sCD163 refers to the value at the follow-up time point minus the value at baseline (Day 0). The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 24, 48, 72The absolute change in IP-10 refers to the value at the follow-up time point minus the value at baseline (Day 0). The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 24, 72Population: Per-protocol (PP) population: All participants who 1) received the Day 0 CMV-MVA Triplex®/placebo injection, 2) did not use prohibited medications from Day 0 until the Week 48 visit, and 3) did not have a confirmed virologic failure prior to Week 48.
The absolute change in sTNFRII refers to the value at the follow-up time point minus the value at baseline (Day 0).
Outcome measures
| Measure |
CMV-MVA Triplex
n=57 Participants
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 Participants
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Change in sTNFRII
Week 12
|
83 pg/mL
Standard Deviation 394
|
222 pg/mL
Standard Deviation 857
|
|
Change in sTNFRII
Week 24
|
-9 pg/mL
Standard Deviation 327
|
-22 pg/mL
Standard Deviation 630
|
|
Change in sTNFRII
Week 72
|
187 pg/mL
Standard Deviation 570
|
89 pg/mL
Standard Deviation 845
|
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 24, 48, 72The absolute change in D-Dimers refers to the value at the follow-up time point minus the value at baseline (Day 0). The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Day 0 and Weeks 12, 48, and 72Detectable CMV DNA shedding at each time point (yes/no) The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Weeks 12, 48, and 72Detectable CMV DNA shedding at each time point (yes/no) The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Weeks 12,48, and 72Detectable CMV DNA shedding at each time point (yes/no) The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at Weeks 12,48, and 72Detectable CMV DNA shedding at each time point (yes/no) The results for this secondary outcome measure are not yet available as the laboratory testing needed to derive this outcome measure was delayed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 0 through Week 96Population: Modified intent-to-treat (mITT) Population: All participants who initiated study treatment (received at least one injection of study treatment)
Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events were graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Higher scores/grades mean a worse outcome.
Outcome measures
| Measure |
CMV-MVA Triplex
n=61 Participants
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 Participants
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Occurrence of Grade ≥3 AEs
|
19 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to week 12This primary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to Week 12This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to week 12This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to Week 48This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to Week 48This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 0 to Week 48This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 12This secondary outcome was moved to exploratory per LOA #2.
Outcome measures
Outcome data not reported
Adverse Events
CMV-MVA Triplex
Serious events: 7 serious events
Other events: 56 other events
Deaths: 2 deaths
Placebo
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CMV-MVA Triplex
n=61 participants at risk
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 participants at risk
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Gait disturbance
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Abdominal infection
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Periorbital cellulitis
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Psychiatric disorders
Bipolar disorder
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Renal and urinary disorders
Bladder mass
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
Other adverse events
| Measure |
CMV-MVA Triplex
n=61 participants at risk
CMV-MVA Triplex® containing 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine Encoding CMV Antigens by intramuscular (IM) deltoid injections at Entry/Day 0 and week 4.
CMV-MVA Triplex: 5 x 10\^8 plaque-forming unit (pfu) ±0.5 x 10\^8 pfu of MVA Vaccine
|
Placebo
n=29 participants at risk
Placebo (7.5% lactose in phosphate-buffered saline) that matched the volume of the active vaccine injection by IM deltoid injections at Entry/Day 0 and week 4.
Placebo: 7.5% lactose in phosphate-buffered saline
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.5%
7/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Cardiac disorders
Tachycardia
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Nausea
|
23.0%
14/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
13/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Asthenia
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Chills
|
54.1%
33/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Fatigue
|
18.0%
11/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
10.3%
3/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site erythema
|
4.9%
3/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site mass
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site pain
|
54.1%
33/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
24.1%
7/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site swelling
|
9.8%
6/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Injection site warmth
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Malaise
|
23.0%
14/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Non-cardiac chest pain
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Pain
|
6.6%
4/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
General disorders
Pyrexia
|
34.4%
21/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Immune system disorders
Hypersensitivity
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
COVID-19
|
8.2%
5/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
6.9%
2/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Cellulitis
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Gastroenteritis viral
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Oral herpes
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Infections and infestations
Suspected COVID-19
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Investigations
Creatinine renal clearance decreased
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Investigations
Blood phosphorus decreased
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Investigations
Blood pressure increased
|
0.00%
0/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Investigations
Body temperature increased
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Investigations
Glomerular filtration rate decreased
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
3.4%
1/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
4/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
3/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.4%
10/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
3/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
6.9%
2/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Brain fog
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Disturbance in attention
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Dizziness
|
9.8%
6/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Dysgeusia
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Headache
|
29.5%
18/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
6.9%
2/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Mental impairment
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Nervous system disorders
Parosmia
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Psychiatric disorders
Insomnia
|
4.9%
3/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
2/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
|
Vascular disorders
Peripheral coldness
|
1.6%
1/61 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
0.00%
0/29 • From Day 0 to Week 96, or premature study discontinuation
The DAIDS AE Grading Table, Corrected Version 2.1, was used for grading adverse events (AE): * Grade ≥3 AEs * Vaccine-related AEs regardless of grade * AEs that led to a change in study treatment/intervention regardless of grade * AEs meeting the Serious Adverse Event (SAE) definition or Expedited Adverse Event (EAE) reporting requirement * Any Grade ≥0 COVID-19 diagnosis (including any positive SARS-CoV-2 test, regardless of symptoms)
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER