Trial Outcomes & Findings for Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant (NCT NCT01385189)
NCT ID: NCT01385189
Last Updated: 2025-01-06
Results Overview
Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
2 hours post vaccination
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
Cohort 1
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
11
|
11
|
4
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With Different Doses of a Novel Adjuvant
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
n=12 Participants
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
n=4 Participants
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
n=4 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
n=8 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 years
n=5 Participants
|
33.8 years
n=7 Participants
|
26.3 years
n=5 Participants
|
23.3 years
n=4 Participants
|
35.0 years
n=21 Participants
|
32.9 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 hours post vaccinationFrequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1
Outcome measures
| Measure |
Cohort 1
n=12 Participants
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
n=12 Participants
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
n=4 Participants
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
n=4 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
n=8 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
100 µg Na-GST-1/Alhydrogel
|
100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)
|
|---|---|---|---|---|---|---|---|
|
Immediate Vaccine Related Adverse Events
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 126 days post dose 1Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126, as determined by an indirect enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Cohort 1
n=4 Participants
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
n=7 Participants
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
n=3 Participants
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
n=7 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
n=4 Participants
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
100 µg Na-GST-1/Alhydrogel
n=3 Participants
|
100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)
n=6 Participants
|
|---|---|---|---|---|---|---|---|
|
IgG Antibody Response to Na-GST-1
|
17.12 Arbitrary Units
Standard Deviation 24.11
|
210.02 Arbitrary Units
Standard Deviation 366.67
|
66.86 Arbitrary Units
Standard Deviation 105.60
|
64.65 Arbitrary Units
Standard Deviation 74.86
|
69.34 Arbitrary Units
Standard Deviation 107.46
|
117.24 Arbitrary Units
Standard Deviation 117.99
|
89.42 Arbitrary Units
Standard Deviation 97.80
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=12 participants at risk
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
n=12 participants at risk
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
n=4 participants at risk
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
n=4 participants at risk
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
n=8 participants at risk
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Delusional Episode
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 2
n=12 participants at risk
30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
|
Cohort 3
n=4 participants at risk
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
Cohort 4
n=4 participants at risk
100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)
100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
|
Cohort 5
n=8 participants at risk
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)
100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
|
|---|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
50.0%
6/12 • Number of events 13
|
33.3%
4/12 • Number of events 8
|
75.0%
3/4 • Number of events 5
|
25.0%
1/4 • Number of events 3
|
62.5%
5/8 • Number of events 8
|
|
General disorders
Injection Site Tenderness
|
33.3%
4/12 • Number of events 9
|
41.7%
5/12 • Number of events 9
|
75.0%
3/4 • Number of events 6
|
50.0%
2/4 • Number of events 2
|
50.0%
4/8 • Number of events 8
|
|
General disorders
Injection Site Erythema
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/4
|
0.00%
0/4
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Injection Site Swelling
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
25.0%
1/4 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 4
|
16.7%
2/12 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
25.0%
2/8 • Number of events 2
|
|
Nervous system disorders
Headache
|
66.7%
8/12 • Number of events 11
|
58.3%
7/12 • Number of events 10
|
50.0%
2/4 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Arthrlagia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/8
|
|
Immune system disorders
Urticaria
|
0.00%
0/12
|
0.00%
0/12
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/8
|
Additional Information
Dr. David J. Diemert, Associate Professor
George Washington University
Phone: 202.994.2909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place