Trial Outcomes & Findings for Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine (NCT NCT03055000)
NCT ID: NCT03055000
Last Updated: 2020-08-11
Results Overview
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
1 year after vaccination (study duration)
Results posted on
2020-08-11
Participant Flow
Participant milestones
| Measure |
AGS-v
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses givemn 21 days apart
|
Placebo
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine
Baseline characteristics by cohort
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
Total
n=49 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
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 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
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 year after vaccination (study duration)Population: All subjects who received vaccination
Grade 3 or higher adverse events identified within 1 year after 2 vaccinations 21 days apart.
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
AEs Grade 3 or Higher
|
0.44 adverse events
Interval 0.16 to 0.63
|
0.65 adverse events
Interval 0.23 to 0.93
|
0.63 adverse events
Interval 0.22 to 0.89
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
GM-CSF Cytokine Level as Measured by Luminex
|
1.106 pg/mL
Standard Deviation 0.285
|
3.76 pg/mL
Standard Deviation 6.05
|
1.101 pg/mL
Standard Deviation 1.01
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-10 Cytokine Level as Measured by Luminex
|
0.983 pg/mL
Standard Deviation 0.048
|
1.088 pg/mL
Standard Deviation 0.169
|
0.976 pg/mL
Standard Deviation 0.055
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-1B Cytokine Level as Measured by Luminex
|
1.009 pg/mL
Standard Deviation 0.119
|
0.964 pg/mL
Standard Deviation 0.105
|
0.946 pg/mL
Standard Deviation 0.107
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-2 Cytokine Level as Measured by Luminex
|
1.173 pg/mL
Standard Deviation 0.421
|
1.225 pg/mL
Standard Deviation 0.372
|
1.115 pg/mL
Standard Deviation 0.293
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-4 Cytokine Level as Measured by Luminex
|
1 pg/mL
Standard Deviation 0.027
|
1.018 pg/mL
Standard Deviation 0.047
|
0.991 pg/mL
Standard Deviation 0.027
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-5 Cytokine Level as Measured by Luminex
|
1.267 pg/mL
Standard Deviation 0.664
|
4.389 pg/mL
Standard Deviation 13.32
|
1.022 pg/mL
Standard Deviation 0.091
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Interferon-gamma Cytokine Level as Measured by Luminex
|
1.16 pg/mL
Standard Deviation 0.568
|
1.613 pg/mL
Standard Deviation 0.764
|
1.103 pg/mL
Standard Deviation 0.307
|
PRIMARY outcome
Timeframe: 1 year after vaccination (study duration)Population: All subjects who received vaccination
Percent of people with an AE
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Number of Subjects With 1 or More Aes
|
16 Participants
|
17 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 1 year after vaccination (study duration)Population: All subjects who received vaccination
Percent of people with a Grade 3 or higher AE
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Number of Subjects With 1 or More Grade 3 or Higher AE
|
6 Participants
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
TNF-a Cytokine Level as Measured by Luminex
|
0.995 pg/mL
Standard Deviation 0.104
|
1.255 pg/mL
Standard Deviation 0.573
|
0.993 pg/mL
Standard Deviation 0.078
|
PRIMARY outcome
Timeframe: 21 days after last vaccinationPopulation: All subjects who received vaccination
Total AGS-v specific immunoglobulin measured in serum 14 days after the first and/or second vaccination.
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Total AGS-v Specific Immunoglobulin
|
0.9903 IU/mL
Standard Deviation 0.373
|
4.3115 IU/mL
Standard Deviation 5.08
|
1.0232 IU/mL
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
GM-CSF Cytokine Level as Measured by Luminex
|
1.198 pg/mL
Standard Deviation 1.289
|
1.8 pg/mL
Standard Deviation 5.806
|
0.902 pg/mL
Standard Deviation 0.296
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-10 Cytokine Level as Measured by Luminex
|
1.376 pg/mL
Standard Deviation 2.029
|
1.749 pg/mL
Standard Deviation 1.687
|
0.813 pg/mL
Standard Deviation 0.206
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-1B Cytokine Level as Measured by Luminex
|
0.905 pg/mL
Standard Deviation 0.546
|
0.955 pg/mL
Standard Deviation 0.281
|
0.758 pg/mL
Standard Deviation 0.268
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-2 Cytokine Level as Measured by Luminex
|
1.027 pg/mL
Standard Deviation 0.583
|
1.036 pg/mL
Standard Deviation 0.138
|
0.98 pg/mL
Standard Deviation 0.221
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-4 Cytokine Level as Measured by Luminex
|
1.034 pg/mL
Standard Deviation 0.254
|
1.061 pg/mL
Standard Deviation 0.157
|
0.915 pg/mL
Standard Deviation 0.211
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
IL-5 Cytokine Level as Measured by Luminex
|
2.233 pg/mL
Standard Deviation 4.085
|
3.113 pg/mL
Standard Deviation 5.993
|
0.933 pg/mL
Standard Deviation 0.119
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Interferon-gamma Cytokine Level as Measured by Luminex
|
2.577 pg/mL
Standard Deviation 3.954
|
2.004 pg/mL
Standard Deviation 4.795
|
0.594 pg/mL
Standard Deviation 0.792
|
SECONDARY outcome
Timeframe: Day 42 Mosquito feedingPopulation: All subjects who received vaccination
Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Number of Adults Developed From 100 Eggs
|
69.13 Adult aedes aegypti mosquitoes
Standard Deviation 14.07
|
75.25 Adult aedes aegypti mosquitoes
Standard Deviation 13.55
|
78.53 Adult aedes aegypti mosquitoes
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: Day 42 Mosquito feedingPopulation: All subjects who received vaccination
Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Number of Eggs Laid
|
706 Eggs
Standard Deviation 123.75
|
673.88 Eggs
Standard Deviation 221.29
|
663 Eggs
Standard Deviation 165.51
|
SECONDARY outcome
Timeframe: Day 42 Mosquito feedingPopulation: All subjects who received vaccination
Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Number of Pupae Hatched of 100 Eggs
|
78.93 Number of hatched pupae
Standard Deviation 13.08
|
79.62 Number of hatched pupae
Standard Deviation 14.86
|
81.93 Number of hatched pupae
Standard Deviation 9.08
|
SECONDARY outcome
Timeframe: Day 42 Mosquito feedingPopulation: All subjects who received vaccination
Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Percent of Eggs That Developed Into Pupae
|
11.59 percentage of eggs
Standard Deviation 3.26
|
15.56 percentage of eggs
Standard Deviation 13.58
|
13.76 percentage of eggs
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Day 42 Mosquito feedingPopulation: All subjects who received vaccination
Measurement of changes to Aedes aegypti mosquito life cycle post feeding on blood from participants after vaccination
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Percent of Pupae That Developed Into Adults
|
88.12 percentage of pupae
Standard Deviation 12.8
|
94.96 percentage of pupae
Standard Deviation 6.86
|
95.77 percentage of pupae
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Interferon-gamma and other cytokine markers of Th1 and Th2 response measured in vitro from PBMCs incubated with AGS-v antigens as indicators of Th1 vs. Th2 response
Outcome measures
| Measure |
AGS-v
n=15 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=12 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=12 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
TNF-a Cytokine Level as Measured by Luminex
|
1.392 pg/mL
Standard Deviation 3.464
|
1.382 pg/mL
Standard Deviation 5.867
|
0.707 pg/mL
Standard Deviation 0.554
|
SECONDARY outcome
Timeframe: 60 days after Day 42 Mosquito FeedingPopulation: All subjects who received vaccination
Total AGS-v specific immunoglobulin measured in serum after the first and/or second vaccination.
Outcome measures
| Measure |
AGS-v
n=16 Participants
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=15 Participants
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=15 Participants
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Total AGS-v Specific Immunoglobulin
|
1.0077 IU/mL
Standard Deviation 0.29
|
3.6537 IU/mL
Standard Deviation 4.45
|
1.2011 IU/mL
Standard Deviation 1.27
|
Adverse Events
AGS-v
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
AGS-v With Adjuvant
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGS-v
n=16 participants at risk
825 µg (50 nmol each peptide) non-adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
AGS-v With Adjuvant
n=17 participants at risk
825 µg (50 nmol each peptide) adjuvanted AGS-v vaccine 2 doses given 21 days apart
|
Placebo
n=16 participants at risk
Placebo 2 doses given 21 days apart
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • 1 year
|
17.6%
3/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • 1 year
|
11.8%
2/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Chills
|
12.5%
2/16 • 1 year
|
17.6%
3/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
General disorders
Fatigue
|
31.2%
5/16 • 1 year
|
47.1%
8/17 • 1 year
|
25.0%
4/16 • 1 year
|
|
General disorders
Injection site erythema
|
18.8%
3/16 • 1 year
|
47.1%
8/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
General disorders
Injection site induration
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Injection site pain
|
37.5%
6/16 • 1 year
|
52.9%
9/17 • 1 year
|
25.0%
4/16 • 1 year
|
|
General disorders
Injection site pruritus
|
18.8%
3/16 • 1 year
|
41.2%
7/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
General disorders
Injection site swelling
|
12.5%
2/16 • 1 year
|
52.9%
9/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
General disorders
Pyrexia
|
6.2%
1/16 • 1 year
|
41.2%
7/17 • 1 year
|
25.0%
4/16 • 1 year
|
|
General disorders
Swelling
|
93.8%
15/16 • 1 year
|
94.1%
16/17 • 1 year
|
93.8%
15/16 • 1 year
|
|
General disorders
Tenderness
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Hordeolum
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Laryngitis
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
2/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Investigations
Blood creatine phosphokinase increased
|
18.8%
3/16 • 1 year
|
29.4%
5/17 • 1 year
|
43.8%
7/16 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Blood urea increased
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Investigations
Eosinophil count increased
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Haemoglobin decreased
|
50.0%
8/16 • 1 year
|
35.3%
6/17 • 1 year
|
31.2%
5/16 • 1 year
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Investigations
Neutrophil count decreased
|
31.2%
5/16 • 1 year
|
17.6%
3/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Investigations
White blood cell count decreased
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
Investigations
White blood cell count increased
|
12.5%
2/16 • 1 year
|
5.9%
1/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Investigations
White blood cells urine positive
|
12.5%
2/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
2/16 • 1 year
|
5.9%
1/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
25.0%
4/16 • 1 year
|
17.6%
3/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.2%
1/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
2/16 • 1 year
|
17.6%
3/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
2/16 • 1 year
|
11.8%
2/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
4/16 • 1 year
|
5.9%
1/17 • 1 year
|
12.5%
2/16 • 1 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • 1 year
|
23.5%
4/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
3/16 • 1 year
|
41.2%
7/17 • 1 year
|
31.2%
5/16 • 1 year
|
|
Nervous system disorders
Headache
|
43.8%
7/16 • 1 year
|
47.1%
8/17 • 1 year
|
25.0%
4/16 • 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
18.8%
3/16 • 1 year
|
5.9%
1/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • 1 year
|
11.8%
2/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
1/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema
|
93.8%
15/16 • 1 year
|
88.2%
15/17 • 1 year
|
93.8%
15/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
2/16 • 1 year
|
11.8%
2/17 • 1 year
|
6.2%
1/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • 1 year
|
0.00%
0/17 • 1 year
|
18.8%
3/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
1/16 • 1 year
|
11.8%
2/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.2%
1/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • 1 year
|
5.9%
1/17 • 1 year
|
0.00%
0/16 • 1 year
|
|
Vascular disorders
Systolic hypertension
|
6.2%
1/16 • 1 year
|
0.00%
0/17 • 1 year
|
0.00%
0/16 • 1 year
|
Additional Information
Memoli, Matthew
National Institute of Allergy and Infectious Diseases
Phone: +1 301 443 5971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place