Trial Outcomes & Findings for Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults (NCT NCT03186781)
NCT ID: NCT03186781
Last Updated: 2021-06-16
Results Overview
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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
50 participants
Primary outcome timeframe
7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17
Results posted on
2021-06-16
Participant Flow
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
Participant milestones
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
10
|
10
|
10
|
10
|
|
Overall Study
Received First Product Administration
|
5
|
5
|
10
|
10
|
10
|
10
|
|
Overall Study
Received All Product Administrations
|
5
|
5
|
8
|
9
|
8
|
9
|
|
Overall Study
COMPLETED
|
5
|
5
|
9
|
10
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Moved from Area
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=10 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=10 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18-20
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Age, Customized
21-30
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Age, Customized
31-40
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Age, Customized
41-50
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Age, Customized
51-60
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Age, Customized
61-70
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
25 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Body Mass Index (BMI)
18.5-24.9 kg/m^2
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Body Mass Index (BMI)
25.0-29.9 kg/m^2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Body Mass Index (BMI)
30 kg/m^2 or over
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17Population: Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=8 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=9 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
n=47 Participants
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Pain/Tenderness · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Local Symptom · None
|
4 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
40 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Local Symptom · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Local Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Pain/Tenderness · None
|
4 Participants
|
3 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
40 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Swelling · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Redness · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
10 Participants
|
47 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after DNA A/Sing product administration, at approximately Week 1Population: Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after the DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects 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: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=20 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Pain/Tenderness · None
|
4 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Pain/Tenderness · Mild
|
6 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Swelling · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Local Symptom · Mild
|
6 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Local Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Redness · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Local Symptom · None
|
4 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days after each HA-F A/Sing product administration, at approximately Week 1 and/or at approximately Week 17Population: Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after each HA-F A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects reporting any systemic 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: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=8 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=9 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
n=47 Participants
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Malaise · None
|
4 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
37 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Malaise · Mild
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
10 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Myalgia · None
|
5 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
38 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Headache · None
|
4 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
34 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Headache · Mild
|
1 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
13 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Chills · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Nausea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Nausea · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
46 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Myalgia · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Joint Pain · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
45 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Joint Pain · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Temperature · None
|
5 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
46 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Systemic Symptom · None
|
3 Participants
|
1 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
29 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Systemic Symptom · Mild
|
2 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
16 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each HA-F A/Sing Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 7 days after DNA A/Sing product administration, at approximately Week 1Population: Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).
Subjects recorded the occurrence of solicited symptoms on a diary card for 7 days after DNA A/Sing study product administration and reviewed the diary card with clinic staff at a follow up visit. Subjects 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 subjects reporting any systemic 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: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=20 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Joint Pain · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Malaise · Mild
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Myalgia · None
|
9 Participants
|
8 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Myalgia · Mild
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Headache · None
|
8 Participants
|
7 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Headache · Mild
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Chills · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Nausea · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Nausea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Joint Pain · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Temperature · None
|
10 Participants
|
10 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Systemic Symptom · None
|
7 Participants
|
6 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Systemic Symptom · Mild
|
3 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of DNA A/Sing Product Administration
Malaise · None
|
9 Participants
|
8 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 280Population: Population included all enrolled subjects who had laboratory results available at any study visit post baseline.
Any abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at screening (≤ 84 days before enrollment), Day 0 prior to study product administration (baseline), and at Days 14, 28, 112, 140 and 280. Creatinine results were collected at screening, Day 0 and Day 6. 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: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=10 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=10 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
ALP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
WBC Count
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
Hemoglobin
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
Neutrophil Count
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
Lymphocyte Count
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Abnormal Laboratory Measures of Safety
Eosinophil Count
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 through 4 weeks after each HA-F A/Sing product administration, up to Week 20Population: Population included all enrolled subjects who received at least one HA-F A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza (reported as a separate outcome) 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 subject with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=8 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=9 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
n=47 Participants
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Each HA-F A/Sing Product Administration
Related to study product
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Each HA-F A/Sing Product Administration
Unrelated to study product
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 4 weeks after DNA A/Sing product administration, up to Week 4Population: Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza (reported as a separate outcome) 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 subject with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=20 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following DNA A/Sing Product Administration
Related to study product
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With One or More Unsolicited Non-Serious Adverse Events (AEs) Following DNA A/Sing Product Administration
Unrelated to study product
|
3 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 280Population: Population included all enrolled subjects who received at least one HA-F A/Sing study injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=8 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=9 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following HA-F A/Sing Product Administration
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 280Population: Population included all enrolled subjects who received the DNA A/Sing study injection (N=20).
Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Influenza or Influenza-like Illness (ILIs) Following DNA A/Sing Product Administration
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 280Population: Population included all enrolled subjects who received at least one HA-F A/Sing study injection (N=47). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=8 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
n=9 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Following HA-F A/Sing Product Administration
Related to study product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Serious Adverse Events (SAEs) Following HA-F A/Sing Product Administration
Unrelated to study product
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 through Day 280Population: Population included all enrolled subjects who received the DNA A/Sing study injection (N=20).
SAEs were recorded from receipt of first study product administration through the last expected study visit at Day 280. 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 subject with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=10 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Following DNA A/Sing Product Administration
Related to study product
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Serious Adverse Events (SAEs) Following DNA A/Sing Product Administration
Unrelated to study product
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18Population: Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group.
Hemagglutination inhibition assays (HAI) titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean titers (GMTs). Negative samples were reported and GMTs were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed).
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=22 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=18 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen
H2-naïve
|
NA titer
Values are below lower limit of quantitation for the assay (GMT was less than 10)
|
24 titer
Interval 14.0 to 40.0
|
89 titer
Interval 28.0 to 282.0
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen
H2-exposed
|
—
|
64 titer
Interval 22.0 to 189.0
|
113 titer
Interval 71.0 to 179.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18Population: Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group.
Pseudoviral neutralization antibody titers were determined against the homologous H2N2 A/Singapore/1/57 virus, and were summarized using geometric mean 50% inhibitory concentration (IC50). Negative samples were reported and IC50 titers were calculated using half the limit of detection. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed).
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=22 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=18 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen
H2-naïve
|
127 titer
Interval 65.0 to 251.0
|
844 titer
Interval 382.0 to 1868.0
|
2723 titer
Interval 551.0 to 13466.0
|
—
|
—
|
—
|
—
|
|
Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against A/Singapore/1/1957 (H2N2) Following the Completion of Each Vaccine Regimen
H2-exposed
|
—
|
1279 titer
Interval 351.0 to 4665.0
|
2718 titer
Interval 1041.0 to 7099.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Four weeks after the first dose for groups that received a single vaccination, at Week 4 or two weeks after the second dose for groups that received two vaccinations, at Week 18Population: Overall number analyzed includes the H2-naïve adults (adults with no pre-existing immunity to H2) and H2-exposed adults (may have some H2 immunity). The H2-naïve and H2-exposed number analyzed rows reflect the number of subjects analyzed in each group.
Seroconversion rate: the proportion of subjects achieving seroconversion in hemagglutination inhibition assay (HAI) antibody titer. Seroconversion rates for HAI were summarized as the proportion of individuals in each group experiencing a positive response, defined per the FDA criteria of positivity as either a baseline titer of less than 1:10 and a post vaccination titer of 1:40 or more or a baseline titer of 1:10 or more and a minimum four-fold rise after vaccination. H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) subjects received either a single dose of 20 mcg HA-F A/Sing (H2-naïve), two doses of 60 mcg HA-F A/Sing 16 weeks apart (H2-naïve and H2-exposed), or a 4 mg DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks (H2-naïve and H2-exposed).
Outcome measures
| Measure |
Group 1: HA-F A/Sing (20 mcg), Ages 18-47 Yrs
n=5 Participants
HA-F A/Sing injections (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 2: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
n=22 Participants
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 3A: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 18-47 Yrs
n=18 Participants
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 3B: DNA A/Sing(4 mg)-HA-F A/Sing(60 mcg), Ages 52-70 Yrs
DNA A/Sing injections (4 mg) administered IM by PharmaJet (Day 0); HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Group 4A: HA-F A/Sing (60 mcg), Ages 18-47 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-naïve adults (adults with no pre-existing immunity to H2)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Group 4B: HA-F A/Sing (60 mcg), Ages 52-70 Yrs
HA-F A/Sing injections (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16) in H2-exposed adults (may have some H2 immunity)
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (20 mcg and 60 mcg)
HA-F A/Sing dose groups included H2-naïve and H2-exposed adults who received either a single 20 mcg dose of HA-F A/Sing, two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
|
|---|---|---|---|---|---|---|---|
|
Seroconversion Rate Following the Completion of Each Vaccine Regimen
H2-naïve
|
0 percentage of participants
Interval 0.0 to 52.0
|
31 percentage of participants
Interval 9.1 to 61.0
|
78 percentage of participants
Interval 40.0 to 97.0
|
—
|
—
|
—
|
—
|
|
Seroconversion Rate Following the Completion of Each Vaccine Regimen
H2-exposed
|
—
|
56 percentage of participants
Interval 21.0 to 86.0
|
89 percentage of participants
Interval 52.0 to 100.0
|
—
|
—
|
—
|
—
|
Adverse Events
Overall Incidence HA-F A/Sing (20 mcg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Overall Incidence HA-F A/Sing (60 mcg)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Overall Incidence DNA A/Sing (4 mg)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Incidence HA-F A/Sing (20 mcg)
n=5 participants at risk
HA-F A/Sing (20 mcg) dose group included H2-naïve (ages 18-47 years) adults who received a single 20 mcg dose of HA-F A/Sing.
Population included all enrolled subjects who received a HA-F A/Sing (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5).
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (60 mcg)
n=42 participants at risk
HA-F A/Sing (60 mcg) dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received either two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
Population included all enrolled subjects who received at least one HA-F A/Sing (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=42). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Overall Incidence DNA A/Sing (4 mg)
n=20 participants at risk
DNA A/Sing prime dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.4%
1/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
Other adverse events
| Measure |
Overall Incidence HA-F A/Sing (20 mcg)
n=5 participants at risk
HA-F A/Sing (20 mcg) dose group included H2-naïve (ages 18-47 years) adults who received a single 20 mcg dose of HA-F A/Sing.
Population included all enrolled subjects who received a HA-F A/Sing (20 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=5).
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
|
Overall Incidence HA-F A/Sing (60 mcg)
n=42 participants at risk
HA-F A/Sing (60 mcg) dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received either two doses of 60 mcg HA-F A/Sing 16 weeks apart, or a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
Population included all enrolled subjects who received at least one HA-F A/Sing (60 mcg) study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=42). Two subjects in Group 3A and one subject in Group 3B received the prime DNA A/Sing injection but did not receive the boost HA-F A/Sing injection.
VRC-FLUNPF081-00-VP (HA-F A/Sing): VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
Overall Incidence DNA A/Sing (4 mg)
n=20 participants at risk
DNA A/Sing prime dose groups included H2-naïve (ages 18-47 years) and H2-exposed (ages 52-70 years) adults who received a DNA A/Sing prime followed by a single 60 mcg HA-F A/Sing boost at 16 weeks.
Population included all enrolled subjects who received the DNA A/Sing study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=20).
VRC-FLUDNA082-00-VP (DNA A/Sing): VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
19.0%
8/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.4%
1/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.4%
1/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
40.0%
2/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
7.1%
3/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Administration site pain
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
14.3%
6/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
60.0%
12/20 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
General disorders
Malaise
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
21.4%
9/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
21.4%
9/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
28.6%
12/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
25.0%
5/20 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
2.4%
1/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
0.00%
0/42 • Solicited adverse events (AEs) were reported for 7 days after each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject 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 each study injection. Unsolicited AEs were recorded from receipt of the first study injection through the visit scheduled 4 weeks after each study injection. At other time periods between injections and when greater than 4 weeks after the last injection, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through the last study visit.
The overall Arms/Groups summarize AEs collected after each product administration separately and grouped by the study product and dose, including the groups in which 2 different products were administered. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. A subject with multiple experiences of the same event is counted once using the event of worst severity.
|
Additional Information
Martin Gaudinski, MD
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