Trial Outcomes & Findings for Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults (NCT NCT04645147)
NCT ID: NCT04645147
Last Updated: 2026-08-13
Results Overview
Number of participants with at least one solicited local adverse events occurring within seven days of each vaccine dose administration. Local reactogenicity included injection site pain, injection site redness, injection site bruising, and injection site swelling. Adverse events were captured by investigator examination and history from participants.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
During the 7-day period after each dose of vaccine
Results posted on
2026-08-13
Participant Flow
83 participants signed screening consent * 4 withdrew prior to receiving study vaccine * 10 were screen failure * 3 opted to enroll on other study * 26 EBV seropositive after seropositive arm fully enrolled * 40 started study intervention
Participants are defined as completed if they received at least one dose of vaccine and completed day 540.
Participant milestones
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=1 Participants
|
20 Participants
n=1 Participants
|
37 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=1 Participants
|
12 Participants
n=1 Participants
|
27 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=1 Participants
|
17 Participants
n=1 Participants
|
35 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=1 Participants
|
15 Participants
n=1 Participants
|
30 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: During the 7-day period after each dose of vaccinePopulation: Intent to treat population
Number of participants with at least one solicited local adverse events occurring within seven days of each vaccine dose administration. Local reactogenicity included injection site pain, injection site redness, injection site bruising, and injection site swelling. Adverse events were captured by investigator examination and history from participants.
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Injection site bruising
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Injection site pain
|
20 Participants
|
18 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Injection site tenderness
|
20 Participants
|
20 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Injection site redness
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs)
Injection site swelling
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During the 7-day period after each dose of vaccinePopulation: Intent to treat population
The severity of local adverse event was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Participants With Solicited Local Adverse Events (AEs) (by Severity)
Grade 1
|
20 Participants
|
20 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) (by Severity)
Grade 2
|
19 Participants
|
19 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) (by Severity)
Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local Adverse Events (AEs) (by Severity)
Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day period after each dose of vaccinePopulation: Intent to treat population
Number of participants with solicited systemic adverse events occurring within seven days of each vaccine dose administration. Systemic reactogenicity events included headache, muscle pain, fatigue, chills, fever, joint pain, nausea, vomiting, and diarrhea. Adverse events were captured by investigator examination and history from participants.
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Diarrhoea
|
6 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Headache
|
16 Participants
|
17 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Myalgia
|
17 Participants
|
16 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Fatigue
|
19 Participants
|
19 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Chills
|
12 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Pyrexia
|
3 Participants
|
5 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Arthralgia
|
9 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Nausea
|
8 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs)
Vomiting
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: During the 7-day period after each dose of vaccinePopulation: Intent to treat population
The severity of systemic adverse events occurring after the administration of each vaccine dose was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) (by Grade)
Grade 1
|
20 Participants
|
20 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) (by Grade)
Grade 2
|
15 Participants
|
18 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) (by Grade)
Grade 3
|
2 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Adverse Events (AEs) (by Grade)
Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within one month after the third dose of vaccine (Day 180 through day 210)Population: Modified intent to treat population
Number of related serious adverse events (AEs) based on the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Serious adverse event is defined as any local or systemic adverse event that * is a life-threatening event, or * an AE that requires inpatient hospitalization or prolongs an existing hospitalization, or * results in a persistent or significant incapacity, or * substantial disruption of the ability to conduct normal life functions, or * is a congenital anomaly/birth defect/miscarriage/still birth, or -- results in death
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Related Serious Adverse Events (AEs)
|
0 Number of adverse events
|
0 Number of adverse events
|
PRIMARY outcome
Timeframe: Within 30 days after each dose of vaccinePopulation: Intent to treat population
Number of related unsolicited adverse events (AEs) occurring within 30 days of each vaccine dose administration. Unsolicited adverse event is defined as an adverse event that is not specifically asked.
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Related Unsolicited Adverse Events
|
43 Number of adverse events
|
40 Number of adverse events
|
PRIMARY outcome
Timeframe: Within 30 days after each dose of vaccinePopulation: Intent to treat population
Number of related unsolicited adverse events (AEs) occurring within 30 days of each vaccine dose administration. Unsolicited adverse event is defined as an adverse event that is not specifically asked.
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Number of Unrelated Unsolicited Adverse Events
|
175 Number of adverse events
|
138 Number of adverse events
|
PRIMARY outcome
Timeframe: Day 0 and Day 210Population: Per the protocol document, only participants who received three doses of vaccine were evaluated. Some participants were excluded - four were infected with EBV, one EBV negative through day 210, two were lost to follow up, one participant missed day 210 visit, and one missed the third vaccine dose.
Change in log10 neutralizing antibody response to Epstein-Barr Virus (EBV) gp350-Ferritin vaccine from day 0 (baseline) to 30 days (Day 210) after the third dose of vaccine as measured by neutralization assay. Serum titer levels were analyzed as geometric means with 95% confidence intervals. Change = 30 days compared to baseline.
Outcome measures
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=15 Participants
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=16 Participants
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Change in Neutralizing Antibody Responses to Epstein-Barr Virus (EBV) gp350-Ferritin Vaccine
|
67.04 Fold change in IC<sub>50
Interval 34.69 to 129.54
|
16.01 Fold change in IC<sub>50
Interval 10.12 to 25.33
|
SECONDARY outcome
Timeframe: Change in antibody responses and change in CD4 T cell responses at 1 month after third dose of vaccine-Change in log10 antibody response to EBV from baseline to 1 month after third vaccine dose measured by a luciferase immunoprecipitation assay; --Change in log10 CD4+ T cell response from baseline to one month after third dose measured by an intracellular cytokine staining assay.
Outcome measures
Outcome data not reported
Adverse Events
Epstein-Barr Virus (EBV) Seronegative Participants
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Epstein-Barr Virus (EBV) Seropositive Participants
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 participants at risk
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 participants at risk
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
General disorders
Mass
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
Other adverse events
| Measure |
Epstein-Barr Virus (EBV) Seronegative Participants
n=20 participants at risk
Participant seronegative for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
Epstein-Barr Virus (EBV) Seropositive Participants
n=20 participants at risk
Participant seropositive for Epstein-Barr Virus (EBV) infection received three doses of the EBV gp350-Ferritin Vaccine 50 µg intramuscularly on study days 0, 30, and 180 with follow-up visits occuring after each dose of vaccine. In addition to vaccine dosing days, mandatory in-person visits occurred in the first week after the first dose of vaccine, one month after the second and third doses of vaccine, and six months after the third dose of vaccine.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
85.0%
17/20 • Through day 540
|
80.0%
16/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
5/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Nervous system disorders
Dizziness
|
20.0%
4/20 • Through day 540
|
30.0%
6/20 • Through day 540
|
|
Nervous system disorders
Dysaesthesia
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Nervous system disorders
Headache
|
80.0%
16/20 • Through day 540
|
85.0%
17/20 • Through day 540
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Nervous system disorders
Tension headache
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Psychiatric disorders
Alcoholic hangover
|
20.0%
4/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Psychiatric disorders
Mood altered
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Psychiatric disorders
Seasonal affective disorder
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Psychiatric disorders
Suicidal ideation
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Renal and urinary disorders
Pollakiuria
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Renal and urinary disorders
Renal disorder
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Reproductive system and breast disorders
Breast mass
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Reproductive system and breast disorders
Endometriosis
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Reproductive system and breast disorders
Ovarian cyst
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
7/20 • Through day 540
|
25.0%
5/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
45.0%
9/20 • Through day 540
|
35.0%
7/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal erythema
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
60.0%
12/20 • Through day 540
|
40.0%
8/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
10.0%
2/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.0%
3/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
10.0%
2/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
20.0%
4/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Acne
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
2/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
15.0%
3/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
2/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
20.0%
4/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Vascular disorders
Raynaud's phenomenon
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Vascular disorders
Superficial vein thrombosis
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Vascular disorders
Systolic hypertension
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
General disorders
Chills
|
60.0%
12/20 • Through day 540
|
55.0%
11/20 • Through day 540
|
|
General disorders
Fatigue
|
95.0%
19/20 • Through day 540
|
95.0%
19/20 • Through day 540
|
|
General disorders
Inflammation
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
General disorders
Injection site erythema
|
10.0%
2/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
General disorders
Injection site pain
|
100.0%
20/20 • Through day 540
|
100.0%
20/20 • Through day 540
|
|
General disorders
Injection site swelling
|
15.0%
3/20 • Through day 540
|
25.0%
5/20 • Through day 540
|
|
General disorders
Pain
|
0.00%
0/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
General disorders
Pyrexia
|
15.0%
3/20 • Through day 540
|
25.0%
5/20 • Through day 540
|
|
General disorders
Swelling face
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
General disorders
Tenderness
|
15.0%
3/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
General disorders
Thirst
|
10.0%
2/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
General disorders
Ulcer
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
General disorders
Vessel puncture site pain
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
Body tinea
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
Candida infection
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
COVID-19
|
0.00%
0/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Infections and infestations
Epstein-Barr viraemia
|
25.0%
5/20 • Through day 540
|
60.0%
12/20 • Through day 540
|
|
Infections and infestations
Epstein-Barr virus infection
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Folliculitis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
Gastroenteritis
|
10.0%
2/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Infections and infestations
Genital herpes
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
Infectious mononucleosis
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Laryngitis
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Otitis media acute
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Respiratory syncytial virus infection
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Infections and infestations
Upper respiratory tract infection
|
65.0%
13/20 • Through day 540
|
50.0%
10/20 • Through day 540
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Infections and infestations
Viral infection
|
15.0%
3/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Animal scratch
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Concussion
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Eye contusion
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Fall
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Seroma
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
5/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Investigations
Anti-thyroid antibody
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Antinuclear antibody increased
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Aspartate aminotransferase decreased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
4/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Autoantibody positive
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Blood alkaline phosphatase decreased
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Blood bicarbonate decreased
|
25.0%
5/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Investigations
Blood chloride increased
|
40.0%
8/20 • Through day 540
|
45.0%
9/20 • Through day 540
|
|
Investigations
Blood cholesterol increased
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
2/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Blood glucose decreased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Blood iron decreased
|
15.0%
3/20 • Through day 540
|
30.0%
6/20 • Through day 540
|
|
Investigations
Blood lactate dehydrogenase abnormal
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Blood pressure increased
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Blood urea decreased
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
C-reactive protein increased
|
5.0%
1/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Investigations
Carbon dioxide abnormal
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Eosinophil count increased
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Epstein-Barr virus antigen positive
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Epstein-Barr virus test positive
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Haematocrit increased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Haemoglobin decreased
|
15.0%
3/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Investigations
Haemoglobin increased
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Hormone level abnormal
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Immature granulocyte count increased
|
30.0%
6/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Laboratory test abnormal
|
70.0%
14/20 • Through day 540
|
45.0%
9/20 • Through day 540
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Lymphocyte count increased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Mean cell volume abnormal
|
20.0%
4/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Neutrophil count decreased
|
15.0%
3/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Neutrophil count increased
|
20.0%
4/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Respiratory rate
|
85.0%
17/20 • Through day 540
|
95.0%
19/20 • Through day 540
|
|
Investigations
SARS-CoV-2 antibody test positive
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
Transferrin saturation decreased
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Vitamin B12 increased
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Investigations
Weight decreased
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Investigations
Weight increased
|
15.0%
3/20 • Through day 540
|
25.0%
5/20 • Through day 540
|
|
Investigations
White blood cell count decreased
|
20.0%
4/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Investigations
White blood cell count increased
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
4/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
55.0%
11/20 • Through day 540
|
50.0%
10/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
15.0%
3/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
20.0%
4/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
45.0%
9/20 • Through day 540
|
45.0%
9/20 • Through day 540
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Endocrine disorders
Goitre
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Eye disorders
Astigmatism
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Eye disorders
Blepharitis
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Eye disorders
Eye disorder
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Eye disorders
Eye irritation
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Eye disorders
Presbyopia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • Through day 540
|
15.0%
3/20 • Through day 540
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Gastrointestinal disorders
Dental caries
|
20.0%
4/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
6/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Frequent bowel movements
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Through day 540
|
45.0%
9/20 • Through day 540
|
|
Gastrointestinal disorders
Oral disorder
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Gastrointestinal disorders
Tooth disorder
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Toothache
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
General disorders
Chest pain
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Blood and lymphatic system disorders
Lymph node pain
|
5.0%
1/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
55.0%
11/20 • Through day 540
|
20.0%
4/20 • Through day 540
|
|
Blood and lymphatic system disorders
Monocytopenia
|
25.0%
5/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Blood and lymphatic system disorders
Splenomegaly
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
10.0%
2/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Cardiac disorders
Bradycardia
|
10.0%
2/20 • Through day 540
|
10.0%
2/20 • Through day 540
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/20 • Through day 540
|
5.0%
1/20 • Through day 540
|
|
Ear and labyrinth disorders
Middle ear effusion
|
10.0%
2/20 • Through day 540
|
0.00%
0/20 • Through day 540
|
Additional Information
Durkee-Shock, Jessica
National Institute of Allergy and Infectious Diseases
Phone: +1 301 761 6539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place