Trial Outcomes & Findings for A Safety and Immunogenicity Trial of IHV01 (NCT NCT02756208)
NCT ID: NCT02756208
Last Updated: 2021-12-16
Results Overview
Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
48 weeks
Results posted on
2021-12-16
Participant Flow
Participant milestones
| Measure |
300 ug FLSC Vaccine
Highest dose vaccine group
|
150 ug FLSC Vaccine
Middle dose vaccine group
|
75 ug FLSC Vaccine
Lowest dose vaccine group
|
Placebo
Placebo control group
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
15
|
16
|
|
Overall Study
COMPLETED
|
13
|
14
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
2
|
4
|
Reasons for withdrawal
| Measure |
300 ug FLSC Vaccine
Highest dose vaccine group
|
150 ug FLSC Vaccine
Middle dose vaccine group
|
75 ug FLSC Vaccine
Lowest dose vaccine group
|
Placebo
Placebo control group
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Safety and Immunogenicity Trial of IHV01
Baseline characteristics by cohort
| Measure |
300 ug FLSC Vaccine
n=18 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 Participants
Lowest dose vaccine group
|
Placebo
n=16 Participants
Placebo control group
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
33.3 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
33.4 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
65 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Intention-to-treat Population - All subjects who received at least one dose of vaccine/placebo
Signs and symptoms include pain, tenderness, maximum severity of pain and/or tenderness, erythema, induration, fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms.
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=18 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 Participants
Lowest dose vaccine group
|
Placebo
n=16 Participants
Placebo control group
|
|---|---|---|---|---|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Headache
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Pruritus
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Nausea
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Fatigue
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Diarrhea
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Chills
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Injection site pain
|
3 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Pyrexia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Reactogenicity Signs and Symptoms
Dizziness
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Intention-to-treat population: Subjects who have received at least one dose of vaccine/placebo.
Treatment emergent adverse events assessed by investigator to be either possibly, probably, or definitely related to study treatment. Medical Dictionary for Regulatory Activities (MedDRA) preferred term, severity, and assessed relationship to study products.
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=18 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 Participants
Lowest dose vaccine group
|
Placebo
n=16 Participants
Placebo control group
|
|---|---|---|---|---|
|
Number of Participants With Related Adverse Events
|
7 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: The analysis included number of participants with sustained (2 consecutive time points) of 30% decrease in CD4 cell/ul and CD4%.
CD4 count was monitored from baseline and at each study visit through study completion. Baseline CD4 and CD4% levels were calculated by taking the average of the screening and first vaccination visits. The number of individuals who had sustained (2 consecutive time points) 30% decrease in CD4 cell/ul and CD4% from baseline were counted.
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=18 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 Participants
Lowest dose vaccine group
|
Placebo
n=16 Participants
Placebo control group
|
|---|---|---|---|---|
|
Number of Participants With Sustained Decrease in CD4 Count and CD4%.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after 4th (last) vaccination.Population: Sample size in each group was less than safety time point because of 8 volunteers who were lost to follow-up, 5 missed vaccination visits/samples, and several samples that had high background levels to individual assays.
Percent of participants with anti-FLSC antibodies as assessed by ELISA by 2 weeks after final vaccination
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=9 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=13 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=11 Participants
Lowest dose vaccine group
|
Placebo
n=13 Participants
Placebo control group
|
|---|---|---|---|---|
|
Binding Antibody Response Rates to FLSC
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after 4th (last) vaccinationPopulation: Sample size in each group was less than safety time point because of 8 volunteers who were lost to follow-up, 5 missed vaccination visits/samples, and several samples that had high background levels to individual assays.
Percent of participants with anti-gp120 antibodies as assessed by ELISA
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=10 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=13 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=11 Participants
Lowest dose vaccine group
|
Placebo
n=13 Participants
Placebo control group
|
|---|---|---|---|---|
|
Binding Antibody Response Rates to BaL-gp120
|
30 percentage of participants
|
46 percentage of participants
|
9 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 2 weeks after 4th (last) vaccinationPopulation: Sample size in each group was less than safety time point because of 8 volunteers who were lost to follow-up, 5 missed vaccination visits/samples, and several samples that had high background levels to individual assays.
Percent of participants with antibodies competing with A32 or 17b as assessed by ELISA.
Outcome measures
| Measure |
300 ug FLSC Vaccine
n=12 Participants
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=14 Participants
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=14 Participants
Lowest dose vaccine group
|
Placebo
n=13 Participants
Placebo control group
|
|---|---|---|---|---|
|
Competitive Antibody Rates to CD4i Epitopes
|
100 percentage of participants
|
100 percentage of participants
|
64 percentage of participants
|
0 percentage of participants
|
Adverse Events
300 ug FLSC Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
150 ug FLSC Vaccine
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
75 ug FLSC Vaccine
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
300 ug FLSC Vaccine
n=18 participants at risk
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 participants at risk
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 participants at risk
Lowest dose vaccine group
|
Placebo
n=16 participants at risk
Control group
|
|---|---|---|---|---|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/18 • 1 year
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • 1 year
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • 1 year
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/18 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
0.00%
0/16 • 1 year
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/18 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
0.00%
0/16 • 1 year
|
Other adverse events
| Measure |
300 ug FLSC Vaccine
n=18 participants at risk
Highest dose vaccine group
|
150 ug FLSC Vaccine
n=16 participants at risk
Middle dose vaccine group
|
75 ug FLSC Vaccine
n=15 participants at risk
Lowest dose vaccine group
|
Placebo
n=16 participants at risk
Control group
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
16.7%
3/18 • Number of events 3 • 1 year
|
50.0%
8/16 • Number of events 13 • 1 year
|
26.7%
4/15 • Number of events 8 • 1 year
|
31.2%
5/16 • Number of events 7 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
22.2%
4/18 • Number of events 4 • 1 year
|
31.2%
5/16 • Number of events 8 • 1 year
|
33.3%
5/15 • Number of events 5 • 1 year
|
12.5%
2/16 • Number of events 3 • 1 year
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • 1 year
|
25.0%
4/16 • Number of events 9 • 1 year
|
20.0%
3/15 • Number of events 4 • 1 year
|
6.2%
1/16 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • 1 year
|
18.8%
3/16 • Number of events 7 • 1 year
|
13.3%
2/15 • Number of events 2 • 1 year
|
31.2%
5/16 • Number of events 6 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
3/18 • Number of events 3 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
13.3%
2/15 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
2/18 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 2 • 1 year
|
13.3%
2/15 • Number of events 3 • 1 year
|
12.5%
2/16 • Number of events 4 • 1 year
|
|
General disorders
Fatigue
|
11.1%
2/18 • Number of events 3 • 1 year
|
12.5%
2/16 • Number of events 3 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Number of events 2 • 1 year
|
12.5%
2/16 • Number of events 6 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Toothache
|
16.7%
3/18 • Number of events 3 • 1 year
|
6.2%
1/16 • Number of events 2 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
2/18 • Number of events 2 • 1 year
|
12.5%
2/16 • Number of events 2 • 1 year
|
0.00%
0/15 • 1 year
|
0.00%
0/16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Number of events 2 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/18 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
13.3%
2/15 • Number of events 3 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
1/18 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 1 • 1 year
|
6.7%
1/15 • Number of events 1 • 1 year
|
6.2%
1/16 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Number of events 1 • 1 year
|
0.00%
0/16 • 1 year
|
13.3%
2/15 • Number of events 3 • 1 year
|
0.00%
0/16 • 1 year
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • Number of events 2 • 1 year
|
0.00%
0/16 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place