Trial Outcomes & Findings for Chikungunya Virus Vaccine Trial in Healthy Adults (NCT NCT01489358)
NCT ID: NCT01489358
Last Updated: 2016-07-25
Results Overview
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
7 days after the first vaccination
Results posted on
2016-07-25
Participant Flow
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland from December 12, 2011 to March 22, 2012
Participant milestones
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Chikungunya Virus Vaccine Trial in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-20 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Age, Customized
21-30 years
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Age, Customized
31-40 years
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Age, Customized
41-50 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days after the first vaccinationPopulation: All subjects who received the first vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Pain/Tenderness
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Swelling
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Redness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Any Local Symptom
|
0 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 7 days after the second vaccinationPopulation: All subjects who received the second vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Pain/Tenderness
|
0 participants
|
2 participants
|
3 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Swelling
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Redness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Any Local Symptom
|
0 participants
|
2 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 7 days after the third vaccinationPopulation: Number of subjects who received the third vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=8 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Pain/Tenderness
|
1 participants
|
3 participants
|
4 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Swelling
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Redness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Any Local Symptom
|
1 participants
|
3 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 7 days after any vaccinationPopulation: Number of subjects who received at least one vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Pain/Tenderness
|
1 participants
|
4 participants
|
4 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Swelling
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Redness
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Any Local Symptom
|
1 participants
|
4 participants
|
4 participants
|
PRIMARY outcome
Timeframe: 7 days after the first vaccinationPopulation: All subjects who received the first vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Malaise
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Myalgia
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Headache
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Chills
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Nausea
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Temperature
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Joint Pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination
Any Systemic Symptom
|
1 participants
|
1 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 7 days after the second vaccinationPopulation: All subjects who received the second vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Malaise
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Myalgia
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Headache
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Chills
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Nausea
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Temperature
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Joint Pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination
Any Systemic Symptom
|
1 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 7 days after the third vaccinationPopulation: Number of subjects who received the third vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=8 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Malaise
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Myalgia
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Headache
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Chills
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Nausea
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Temperature
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Joint Pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination
Any Systemic Symptom
|
1 participants
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 7 days after any vaccinationPopulation: All subjects who received at least one vaccination
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Malaise
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Myalgia
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Headache
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Chills
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Nausea
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Temperature
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Joint Pain
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination
Any Systemic Symptom
|
2 participants
|
3 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 44 weeks after first vaccinationPopulation: All subjects who received at least one vaccination
Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects With an Any Abnormal Laboratory Result
ALT
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
WBC
|
3 participants
|
3 participants
|
0 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Hemoglobin
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Platelets
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Neutrophil Count
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Lymphocyte Count
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Eosinophil Count
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Subjects With an Any Abnormal Laboratory Result
Any Abnormal Lab Result
|
4 participants
|
5 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 44 weeks after first vaccinationPopulation: All subjects who received at least one vaccination
Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 28 days after each vaccinationPopulation: All subjects who received at least one vaccination
Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination. Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Any AE
|
4 participants
|
9 participants
|
6 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Blood and Lymphatic System Disorders
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Infections and Infestations
|
3 participants
|
5 participants
|
4 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Injury, Poisoning and Procedural Complications
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Investigations
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Musculoskeletal and Connective Tissue Disorders
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Surgical and Medical Procedures
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Adverse Event
Vascular Disorders
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 weeks after the first vaccinationPopulation: All subjects who received at least one vaccination
ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)
|
40960 titre
Interval 40960.0 to 40960.0
|
15521 titre
Interval 6058.0 to 39763.0
|
34443 titre
Interval 22862.0 to 51890.0
|
SECONDARY outcome
Timeframe: Pre-vaccination (Week 0)Population: All subjects who received at least one vaccination
Neutralisation IC50 titre (strain OPY1)
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
|
50 titre
Interval 50.0 to 50.0
|
51 titre
Interval 49.0 to 52.0
|
52 titre
Interval 50.0 to 54.0
|
SECONDARY outcome
Timeframe: 24 weeks after the first vaccinationPopulation: All subjects who received at least one vaccination
Neutralisation IC50 titre (strain OPY1)
Outcome measures
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 Participants
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 Participants
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)
|
8745 titre
Interval 1514.0 to 50516.0
|
4525 titre
Interval 2252.0 to 9093.0
|
5390 titre
Interval 1865.0 to 15573.0
|
Adverse Events
Group 1: 10 mcg VRC-CHKVLP059-00-VP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: 20 mcg VRC-CHKVLP059-00-VP
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 3: 40 mcg VRC-CHKVLP059-00-VP
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: 10 mcg VRC-CHKVLP059-00-VP
n=5 participants at risk
Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 2: 20 mcg VRC-CHKVLP059-00-VP
n=10 participants at risk
Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
Group 3: 40 mcg VRC-CHKVLP059-00-VP
n=10 participants at risk
Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
2/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Pharyngitis
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
2/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
30.0%
3/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
2/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
2/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
2/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Surgical and medical procedures
Incisional drainage
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
10.0%
1/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Pain/Tenderness
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
40.0%
4/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
40.0%
4/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
30.0%
3/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Malaise
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
30.0%
3/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
2/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
30.0%
3/10 • Solicited symptoms collected 7 days after each vaccination; unsolicited non-serious, non-chronic adverse events, through 28 days after each vaccination; Serious adverse events and new chronic medical conditions, through 24 weeks after last vaccination.
For the solicited symptoms, participants are counted if reporting the symptom after any vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
Additional Information
Dr Julie E Ledgerwood
Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place