Trial Outcomes & Findings for cAd3-Marburg Vaccine in Healthy Adults (NCT NCT03475056)
NCT ID: NCT03475056
Last Updated: 2022-08-11
Results Overview
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
7 days after study product administration
Results posted on
2022-08-11
Participant Flow
Healthy adults were recruited at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, Maryland, USA.
Participant milestones
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Received Product Administration
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Moved from Area
|
0
|
2
|
Baseline Characteristics
cAd3-Marburg Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-20 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
21-30 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
31-40 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
41-50 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
18.5-24.9 kg/m^2
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
25.0-29.9 kg/m^2
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
30.0-40.0 kg/m^2
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Pain · None
|
9 Participants
|
4 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Pain · Mild
|
10 Participants
|
12 Participants
|
22 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Pain · Moderate
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Swelling · None
|
20 Participants
|
20 Participants
|
40 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Redness · None
|
20 Participants
|
20 Participants
|
40 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Local Symptom · None
|
9 Participants
|
4 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Local Symptom · Mild
|
10 Participants
|
12 Participants
|
22 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Local Symptom · Moderate
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. The majority of the reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007).The Division of AIDS AE Grading Table Corrected (Version 2.1-July 2017) was used to grade reported events of joint pain (arthralgia).
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Unusually Tired/Feeling Unwell (Malaise) · None
|
15 Participants
|
7 Participants
|
22 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Unusually Tired/Feeling Unwell (Malaise) · Mild
|
2 Participants
|
11 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Unusually Tired/Feeling Unwell (Malaise) · Moderate
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Unusually Tired/Feeling Unwell (Malaise) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Muscle Aches (Myalgia) · None
|
15 Participants
|
11 Participants
|
26 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Muscle Aches (Myalgia) · Mild
|
5 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Muscle Aches (Myalgia) · Moderate
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Muscle Aches (Myalgia) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Headache · None
|
14 Participants
|
9 Participants
|
23 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Headache · Mild
|
4 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Headache · Moderate
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Chills · None
|
17 Participants
|
14 Participants
|
31 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Chills · Mild
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Chills · Moderate
|
0 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Nausea · None
|
18 Participants
|
18 Participants
|
36 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Nausea · Mild
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Temperature (Fever) · None
|
20 Participants
|
17 Participants
|
37 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Temperature (Fever) · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Temperature (Fever) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Temperature (Fever) · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Arthralgia · None
|
18 Participants
|
13 Participants
|
31 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Arthralgia · Mild
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Arthralgia · Moderate
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Systemic Symptom · None
|
10 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Systemic Symptom · Mild
|
5 Participants
|
10 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Systemic Symptom · Moderate
|
5 Participants
|
6 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Any Systemic Symptom · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 7 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after the study product administration.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Total Number of Participants who had Any Local Reactogenicity Signs and Symptoms
|
11 Participants
|
16 Participants
|
27 Participants
|
|
Total Number of Participants Reporting Any Reactogenicity Signs and Symptoms for 7 Days After the cAd3-Marburg Vaccine Administration
Total Number of Participants who had Any Systemic Reactogenicity Signs and Symptoms
|
10 Participants
|
17 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Through 48 weeks after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Any abnormal laboratory results recorded as unsolicited AEs are summarized. Labs included hematology (hemoglobin, hemoglobin change from baseline, hematocrit percent, mean corpuscular volume (MCV), platelets, and white blood cell (WBC), red blood cell (RBC) and lymphocyte counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete blood count (CBC) with total lymphocyte count results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), Day 3, and Weeks 2, 4, 8 and 24. Creatinine and ALT results were collected at screening, Day 0, Day 3 and Weeks 2, 4 and 8. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety
ALT
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety
WBC Count
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety
Hemoglobin
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety
Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs
|
3 Participants
|
8 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Related to Study Product
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Unrelated to Study Product
|
6 Participants
|
11 Participants
|
17 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs)
Total Number of Participants who had One or More Non-Serious Unsolicited AE
|
6 Participants
|
16 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Through 48 weeks after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
SAEs were recorded from receipt of the study product administration through the last expected study visit at Week 48. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
n=40 Participants
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs)
Unrelated to Study Product
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs)
Total Number of Participants who had an SAE
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Vaccine-induced, cAd3-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for cAd3-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Week 0 (Baseline, Pre-Administration)
|
49.3 90% inhibitory concentration(IC90)titer
Interval 27.0 to 89.9
|
48.8 90% inhibitory concentration(IC90)titer
Interval 22.9 to 89.9
|
—
|
|
Mean Titers of Antibodies to the Recombinant Chimpanzee Adenovirus Serotype 3 (cAd3) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Week 4 (28 Days After Product Administration)
|
414.6 90% inhibitory concentration(IC90)titer
Interval 232.6 to 739.0
|
437.1 90% inhibitory concentration(IC90)titer
Interval 255.8 to 746.8
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Vaccine-induced, Ad5-specific antibody responses as measured by neutralization assay. Participant blood samples were tested for Ad5-specific neutralizing activity, prior to and following vaccination, using a luciferase reporter gene virus neutralization assay as previously described (Clin Vaccine Immunol 2014; 21:783-6, References Section).
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Week 0 (Baseline, Pre-Administration)
|
101.1 90% inhibitory concentration(IC90)titer
Interval 25.7 to 396.8
|
224.2 90% inhibitory concentration(IC90)titer
Interval 61.0 to 396.8
|
—
|
|
Mean Titers of Antibodies to the Human Adenovirus Serotype 5 (Ad5) Vector at 28 Days After the cAd3-Marburg Vaccine Administration
Week 4 (28 Days after Product Administration)
|
181.6 90% inhibitory concentration(IC90)titer
Interval 50.7 to 650.2
|
405.1 90% inhibitory concentration(IC90)titer
Interval 116.6 to 1407.4
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
A positive response occurs if there is a significant increase in the ELISA post vaccination compared to baseline. For each participant, a t-test was performed to compare the post vaccination titers versus those at baseline. A participant is defined as a positive responder if the one-sided t-test has a p-value \< 0.05.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Percentage of Participants With a Positive Marburg-Specific Antibody Response After the cAd3-Marburg Vaccine Administration
|
95 Percentage of responders
Interval 75.0 to 100.0
|
95 Percentage of responders
Interval 75.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Geometric mean titer (GMT) was calculated along with 95% confidence intervals at Week 4 for each dose group.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Magnitude of Marburg-Specific Antibody Responses After the cAd3-Marburg Vaccine Administration
|
420.78 titer
Interval 209.3 to 845.98
|
545.11 titer
Interval 275.63 to 1078.07
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
T cell response was measured by Intracellular Cytokine Staining (ICS) assays using Peripheral Blood Mononuclear Cells (PBMCs) at 4 weeks after vaccination. The percentage of participants with T cell responses with Clopper-Pearson 95% Confidence Intervals are presented. Positivity is defined as a response over calculated thresholds determined by the trial statistician.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
Percentage of Participants who produced at least one CD8 cytokine
|
30 Percentage of responders
Interval 12.0 to 54.0
|
20 Percentage of responders
Interval 6.0 to 44.0
|
—
|
|
Percentage of Participants With Positive Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
Percentage of Participants who produced at least one CD4 cytokine
|
70 Percentage of responders
Interval 46.0 to 88.0
|
95 Percentage of responders
Interval 75.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Through 28 days after study product administrationPopulation: All participants who received the cAd3-Marburg vaccine.
Median and interquartile ranges presented for total cytokine responses for both CD4 and CD8 memory T cells based on a T cell response with any cytokine at Week 4 for each dose group.
Outcome measures
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 Participants
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Overall Incidence cAd3-Marburg Vaccine (1x10^10 PU and 1X10^11 PU)
Dose groups included adults who received either a single dose of cAd3-Marburg vaccine at 1x10\^10 PU or 1X10\^11 PU
|
|---|---|---|---|
|
Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
CD4
|
0.10 percent of subset
Interval 0.07 to 0.16
|
0.11 percent of subset
Interval 0.08 to 0.13
|
—
|
|
Magnitude of Marburg-specific T Cell Responses After the cAd3-Marburg Vaccine Administration
CD8
|
0.08 percent of subset
Interval 0.05 to 0.25
|
0.11 percent of subset
Interval 0.08 to 0.21
|
—
|
Adverse Events
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 participants at risk
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 participants at risk
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
|---|---|---|
|
Infections and infestations
Staphylococcal infection
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
Other adverse events
| Measure |
Group 1: cAd3-Marburg Vaccine (1x10^10 PU)
n=20 participants at risk
cAd3-Marburg vaccine (1x10\^10 PU) administered intramuscularly (IM) with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
Group 2: cAd3-Marburg Vaccine (1x10^11 PU)
n=20 participants at risk
cAd3-Marburg vaccine (1x10\^11 PU) administered IM with needle and syringe in a volume of 1 mL
cAd3-Marburg vaccine: The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
|
|---|---|---|
|
General disorders
Administration site pain
|
55.0%
11/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
80.0%
16/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Malaise
|
25.0%
5/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
65.0%
13/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
5/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
45.0%
9/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Chills
|
15.0%
3/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
30.0%
6/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
15.0%
3/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
35.0%
7/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
4/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Cardiac disorders
Tachycardia
|
10.0%
2/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Foreign Body Reaction
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
20.0%
4/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
5.0%
1/20 • Solicited adverse events (AEs) were reported for 7 days after the study product administration. Unsolicited AEs were recorded from receipt of the study product administration through the visit scheduled for 28 days after study product administration. At other time periods greater than 28 days after the study product administration, only serious AEs (SAEs), and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
All AEs recorded on the study were reported. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment are reported for participants who received study product and had safety data collected following the product administration. Data represent the number and percentage of participants experiencing the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
|
Additional Information
VRC Clinical Trials Program Leadership
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place