Trial Outcomes & Findings for A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine (NCT NCT05065983)
NCT ID: NCT05065983
Last Updated: 2023-07-03
Results Overview
CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
21 days post vaccination
Results posted on
2023-07-03
Participant Flow
Participants were recruited at 1 U.S. site.
Participant milestones
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
Exposed
|
25
|
|
Overall Study
Safety
|
25
|
|
Overall Study
mITT
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Baseline characteristics by cohort
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
|
Day 1 predose (baseline) geometric mean anti-chikungunya luciferase neutralizing antibody titer.
|
7.5 Titer
n=99 Participants
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: mITT
CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: mITT
CHIKV SNA GMT and Associated 95% CI at Day 22
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV SNA GMT (Geometric Mean Titer) at Day 22
|
2365.2 Titer
Interval 1625.0 to 3442.4
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
Day 8 titer at or above 40
|
76.0 Percentage of participants
Interval 56.6 to 88.5
|
|
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
Day 15 titer at or above 40
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
Day 57 titer at or above 40
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV SNA GMTs at Days 8, 15, and 57
Day 8
|
117.4 Titer
Interval 68.3 to 201.8
|
|
CHIKV SNA GMTs at Days 8, 15, and 57
Day 15
|
1397.1 Titer
Interval 901.9 to 2164.2
|
|
CHIKV SNA GMTs at Days 8, 15, and 57
Day 57
|
1069.7 Titer
Interval 720.2 to 1588.9
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
Day 8
|
0.71 Titer
Interval 0.66 to 0.77
|
|
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
Day 15
|
1.1 Titer
Interval 0.88 to 1.4
|
|
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
Day 22
|
1.5 Titer
Interval 1.3 to 1.9
|
|
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
Day 57
|
1.2 Titer
Interval 1.0 to 1.4
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
Day 8
|
1.2 Titer
Interval 0.93 to 1.6
|
|
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
Day 15
|
5.0 Titer
Interval 4.0 to 6.3
|
|
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
Day 22
|
6.2 Titer
Interval 5.0 to 7.7
|
|
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
Day 57
|
2.9 Titer
Interval 2.1 to 3.8
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
Day 8
|
15.6 Fold increase
Interval 9.1 to 26.9
|
|
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
Day 15
|
186.3 Fold increase
Interval 120.3 to 288.6
|
|
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
Day 22
|
315.4 Fold increase
Interval 216.7 to 459.0
|
|
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
Day 57
|
142.6 Fold increase
Interval 96.0 to 211.9
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
Day 8
|
0.93 Fold increase
Interval 0.77 to 1.1
|
|
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
Day 15
|
1.4 Fold increase
Interval 1.0 to 2.0
|
|
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
Day 22
|
2.0 Fold increase
Interval 1.5 to 2.6
|
|
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
Day 57
|
1.7 Fold increase
Interval 1.4 to 2.1
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
Day 8
|
3.1 Fold increase
Interval 2.3 to 4.1
|
|
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
Day 15
|
12.6 Fold increase
Interval 9.9 to 16.1
|
|
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
Day 22
|
15.6 Fold increase
Interval 12.6 to 19.4
|
|
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
Day 57
|
7.2 Fold increase
Interval 5.3 to 9.8
|
PRIMARY outcome
Timeframe: 56 days post vaccinationPopulation: mITT
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 15
|
96.0 Percentage of participants
Interval 80.5 to 99.3
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 40
|
76.0 Percentage of participants
Interval 56.6 to 88.5
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 60
|
68.0 Percentage of participants
Interval 48.4 to 82.8
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 80
|
56.0 Percentage of participants
Interval 37.1 to 73.3
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 100
|
52.0 Percentage of participants
Interval 33.5 to 70.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 160
|
48.0 Percentage of participants
Interval 30.0 to 66.5
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 640
|
12.0 Percentage of participants
Interval 4.2 to 30.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 8 : Titer at or above 4-fold rise over baseline
|
88.0 Percentage of participants
Interval 70.0 to 95.8
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 15
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 40
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 60
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 80
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 100
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 160
|
96.0 Percentage of participants
Interval 80.5 to 99.3
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 640
|
76.0 Percentage of participants
Interval 56.6 to 88.5
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 15 : Titer at or above 4-fold rise over baseline
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 15
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 40
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 60
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 80
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 100
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 160
|
96.0 Percentage of participants
Interval 80.5 to 99.3
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 640
|
92.0 Percentage of participants
Interval 75.0 to 97.8
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 22 : Titer at or above 4-fold rise over baseline
|
100.0 Percentage of participants
Interval 86.7 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 15
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 40
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 60
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 80
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 100
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 160
|
95.8 Percentage of participants
Interval 79.8 to 99.3
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 640
|
75.0 Percentage of participants
Interval 55.1 to 88.0
|
|
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
Day 57 : Titer at or above 4-fold rise over baseline
|
100.0 Percentage of participants
Interval 86.2 to 100.0
|
SECONDARY outcome
Timeframe: 7 days post vaccinationPopulation: Safety population
Incidence of Solicited AEs Through Day 8
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Any solicited AE
|
17 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Any systemic solicited AE
|
12 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Fever
|
1 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Chills
|
1 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Fatigue
|
8 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Headache
|
7 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Myalgia
|
5 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Arthralgia
|
2 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Nausea
|
2 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Any local solicited AE
|
14 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Injection site pain
|
14 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Injection site redness
|
0 Participants
|
|
Incidence of Solicited Adverse Events (AE) Through Day 8
Injection site swelling
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days post vaccinationPopulation: Safety population
Incidence of Unsolicited AEs Through Day 29
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Incidence of Unsolicited AEs Through Day 29
Oropharyngeal pain
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Participants with any unsolicited AEs
|
8 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
General disorders and administration site conditions
|
2 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Vessel puncture site bruise
|
2 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Immune system disorders
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Anaphylactic reaction
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Infections and infestations
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Sinusitis
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Musculoskeletal and connective tissue disorders
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Myalgia
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Nervous system disorders
|
5 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Dizziness
|
2 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Presyncope
|
3 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Headache
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Psychiatric disorders
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Anxiety
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Respiratory, thoracic and mediastinal disorders
|
2 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Rhinorrhoea
|
2 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Vascular disorders
|
1 Participants
|
|
Incidence of Unsolicited AEs Through Day 29
Hot flush
|
1 Participants
|
SECONDARY outcome
Timeframe: 182 days post vaccinationPopulation: Safety population
Incidence of AESIs Through Day 183
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Incidence of Adverse Events of Special Interest (AESI) Through Day 183
|
0 Participants
|
SECONDARY outcome
Timeframe: 182 days post vaccinationPopulation: Safety population
Incidence of SAEs Through Day 183
Outcome measures
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 Participants
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Incidence of Serious Adverse Events (SAEs) Through Day 183
|
0 Participants
|
Adverse Events
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine
n=25 participants at risk
All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
CHIKV VLP, adjuvanted: Adjuvanted formulation includes aluminum hydroxide
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
General disorders
Injection site pain
|
56.0%
14/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
General disorders
Fatigue
|
32.0%
8/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
General disorders
Vessel puncture site bruise
|
8.0%
2/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
General disorders
Chills
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Immune system disorders
Anaphylactic reaction
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Infections and infestations
Sinusitis
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.0%
6/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Nervous system disorders
Headache
|
28.0%
7/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Nervous system disorders
Presyncope
|
12.0%
3/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
2/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
|
Vascular disorders
Hot flush
|
4.0%
1/25 • AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may publish or release study data after the earlier of (a) the date of publication of a multi-center publication coordinated by Sponsor on the study data, or (b) the date of submission of the study data by Sponsor to regulatory authorities for regulatory approval; provided that PI furnishes Sponsor with a copy of any proposed publication or release at least ninety days in advance of the proposed submission or presentation date for review. PI must acknowledge Sponsor on any publication.
- Publication restrictions are in place
Restriction type: OTHER