Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine (NCT NCT04009824)
NCT ID: NCT04009824
Last Updated: 2022-04-28
Results Overview
A treatment emergent adverse event is any untoward medical occurrence in a human subject that manifest after administration of the study treatment, whether or not considered related to the treatment. AE severity was graded using FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007 or the following grading scale: Grade 1 (Mild) Events causing no or minimal interference with daily activity and not requiring medical intervention Grade 2 (Moderate) Events causing greater than minimal interference with daily activity but not requiring medical intervention Grade 3 (Severe) Events causing inability to perform daily activity and/or requiring medical intervention Grade 4 (Potentially Life-Threatening)\* Events causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5 (Death) Events causing death
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
1 year
Results posted on
2022-04-28
Participant Flow
Participant milestones
| Measure |
Group 1: Saline Placebo
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
11
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
5
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group 1: Saline Placebo
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Overall Study
COVID-19 pandemic restriction/closure
|
2
|
3
|
5
|
2
|
3
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: Saline Placebo
n=10 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=10 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=11 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=10 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=10 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
Total
n=51 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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
51 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
49 Participants
n=10 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
|
0 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (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
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
51 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All participants who started the study
A treatment emergent adverse event is any untoward medical occurrence in a human subject that manifest after administration of the study treatment, whether or not considered related to the treatment. AE severity was graded using FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007 or the following grading scale: Grade 1 (Mild) Events causing no or minimal interference with daily activity and not requiring medical intervention Grade 2 (Moderate) Events causing greater than minimal interference with daily activity but not requiring medical intervention Grade 3 (Severe) Events causing inability to perform daily activity and/or requiring medical intervention Grade 4 (Potentially Life-Threatening)\* Events causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death Grade 5 (Death) Events causing death
Outcome measures
| Measure |
Group 1: Saline Placebo
n=10 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=10 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=11 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=10 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=10 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Grade 2
|
3 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Grade 3
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Grade 1
|
7 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Day 43Population: All participants who completed the study and had sample available
Mean log10 titer in serum AGS-v PLUS specific immunoglobulin E (IgE), immunoglobulin G (IgG), and immunoglobulin M (IgM) titers were assessed using enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=8 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=7 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers
IgE
|
2.5399 log10 titer
Standard Deviation 0.1666
|
2.4628 log10 titer
Standard Deviation 0.1606
|
2.4915 log10 titer
Standard Deviation 0.1552
|
2.4414 log10 titer
Standard Deviation 0.1606
|
2.5058 log10 titer
Standard Deviation 0.1466
|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers
IgG
|
3.3425 log10 titer
Standard Deviation 0.7442
|
3.8098 log10 titer
Standard Deviation 0.4761
|
3.7625 log10 titer
Standard Deviation 0.6941
|
4.1428 log10 titer
Standard Deviation 0.4795
|
3.3863 log10 titer
Standard Deviation 0.3979
|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers
IgM
|
3.0480 log10 titer
Standard Deviation 0.3253
|
3.0465 log10 titer
Standard Deviation 0.3513
|
3.3010 log10 titer
Standard Deviation 0.4430
|
3.4840 log10 titer
Standard Deviation 0.5158
|
3.1993 log10 titer
Standard Deviation 0.4856
|
PRIMARY outcome
Timeframe: Day 1 and Day 43Population: All participants who completed the study and had sample available
Mean log10 fold change in serum AGS-v PLUS specific immunoglobulin G (IgG), immunoglobulin M (IgM) and immunoglobulin E (IgE) titers from day 1 to day 43 assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 1 to day 43 is calculated by dividing the antibody titer for a specific isotype i.e. IgE at day 43 by the titer at day 1. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=8 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=7 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgE
|
0.0553 log10 fold change
Standard Deviation 0.1563
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgG
|
-0.0151 log10 fold change
Standard Deviation 0.0553
|
0.2432 log10 fold change
Standard Deviation 0.2250
|
1.1274 log10 fold change
Standard Deviation 0.7249
|
1.3033 log10 fold change
Standard Deviation 0.7104
|
0.5336 log10 fold change
Standard Deviation 0.5084
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgM
|
-0.0121 log10 fold change
Standard Deviation 0.0963
|
0.1826 log10 fold change
Standard Deviation 0.2759
|
0.2988 log10 fold change
Standard Deviation 0.4061
|
0.5530 log10 fold change
Standard Deviation 0.4568
|
-0.0114 log10 fold change
Standard Deviation 0.2509
|
PRIMARY outcome
Timeframe: Day 43Population: All participants who completed the study and had sample available
Mean log10 concentration in Th1 (IFN-gamma) and Th2 (IL-4) cytokine responses after in vitro exposure of peripheral blood mononuclear cells (PBMCs) with AGS-v PLUS antigens assessed using enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=8 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=7 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
IFN-gamma
|
0.1909 pg/ml
Standard Deviation 0.6279
|
1.4052 pg/ml
Standard Deviation 1.1236
|
1.6730 pg/ml
Standard Deviation 0.9671
|
1.5934 pg/ml
Standard Deviation 0.8151
|
1.5007 pg/ml
Standard Deviation 1.1989
|
|
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
IL4
|
-2.1753 pg/ml
Standard Deviation 1.2352
|
-2.3499 pg/ml
Standard Deviation 1.2972
|
-0.8076 pg/ml
Standard Deviation 2.2295
|
-0.7952 pg/ml
Standard Deviation 1.7543
|
0.4814 pg/ml
Standard Deviation 1.5686
|
PRIMARY outcome
Timeframe: Day 1 and Day 43Population: All participants who completed the study and had sample available
Mean log10 fold change in Th1 (IFN-gamma) and Th2 (IL-4) cytokine responses after in vitro exposure of peripheral blood mononuclear cells (PBMCs) with AGS-v PLUS antigens from day 1 to day 43 assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 1 to day 43 is calculated by dividing the antigen titer for a specific isotype i.e. IFN-gamma at day 43 by the titer at day 1. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=7 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=8 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=7 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IFN-gamma
|
-1.0560 log10 fold change
Standard Deviation 1.2765
|
0.7983 log10 fold change
Standard Deviation 1.6906
|
1.1645 log10 fold change
Standard Deviation 1.7015
|
1.0486 log10 fold change
Standard Deviation 1.1661
|
0.9757 log10 fold change
Standard Deviation 1.4482
|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IL4
|
0.3529 log10 fold change
Standard Deviation 0.9338
|
0.0576 log10 fold change
Standard Deviation 0.1523
|
1.6160 log10 fold change
Standard Deviation 1.9909
|
1.4378 log10 fold change
Standard Deviation 1.4169
|
3.2786 log10 fold change
Standard Deviation 1.5472
|
SECONDARY outcome
Timeframe: Day 50Population: All participants who completed the study and had sample available
Mean log10 titer in serum AGS-v PLUS specific immunoglobulin G (IgG), immunoglobulin M (IgM) and immunoglobulin E (IgE) titers seven days after mosquito feeding assessed using enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgG
|
3.3322 log10 titer
Standard Deviation 0.7409
|
3.7976 log10 titer
Standard Deviation 0.4694
|
3.8225 log10 titer
Standard Deviation 0.7273
|
4.4132 log10 titer
Standard Deviation 0.4667
|
3.4214 log10 titer
Standard Deviation 0.3945
|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgE
|
2.502 log10 titer
Standard Deviation 0.1362
|
2.4628 log10 titer
Standard Deviation 0.1606
|
2.4915 log10 titer
Standard Deviation 0.1552
|
2.4074 log10 titer
Standard Deviation 0.1475
|
2.4915 log10 titer
Standard Deviation 0.1552
|
|
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgM
|
3.0461 log10 titer
Standard Deviation 0.3381
|
3.0263 log10 titer
Standard Deviation 0.3157
|
3.3270 log10 titer
Standard Deviation 0.4327
|
3.7576 log10 titer
Standard Deviation 0.2931
|
3.2060 log10 titer
Standard Deviation 0.4878
|
SECONDARY outcome
Timeframe: Day 1 and Day 50Population: All participants who completed the study and had sample available
Mean log10 fold change in serum AGS-v PLUS specific immunoglobulin G (IgG), immunoglobulin M (IgM) and immunoglobulin E (IgE) titers from day 1 to day 50 assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 1 to day 50 is calculated by dividing the antibody titer for a specific isotype i.e. IgE at day 50 by the titer at day 1. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgE
|
0.0174 log10 fold change
Standard Deviation 0.0491
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0161 log10 fold change
Standard Deviation 0.0395
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgG
|
-0.0254 log10 fold change
Standard Deviation 0.0552
|
0.2309 log10 fold change
Standard Deviation 0.2134
|
1.1874 log10 fold change
Standard Deviation 0.7482
|
1.4047 log10 fold change
Standard Deviation 0.8537
|
0.5295 log10 fold change
Standard Deviation 0.4994
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgM
|
-0.0139 log10 fold change
Standard Deviation 0.0967
|
0.1623 log10 fold change
Standard Deviation 0.2306
|
0.3247 log10 fold change
Standard Deviation 0.3746
|
0.6928 log10 fold change
Standard Deviation 0.5505
|
0.0204 log10 fold change
Standard Deviation 0.3250
|
SECONDARY outcome
Timeframe: Day 43 and Day 50Population: All participants who completed the study and had sample available
Mean log10 fold change in serum AGS-v PLUS specific immunoglobulin G (IgG), immunoglobulin M (IgM) and immunoglobulin E (IgE) titers seven days after mosquito feeding assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 43 to day 50 is calculated by dividing the antibody titer for a specific isotype i.e. IgE at day 50 by the titer at day 43. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgE
|
-0.0379 log10 fold change
Standard Deviation 0.1072
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
0.0161 log10 fold change
Standard Deviation 0.0395
|
0.0000 log10 fold change
Standard Deviation 0.0000
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgG
|
-0.0103 log10 fold change
Standard Deviation 0.0102
|
-0.0122 log10 fold change
Standard Deviation 0.0328
|
0.0601 log10 fold change
Standard Deviation 0.0705
|
0.1256 log10 fold change
Standard Deviation 0.0968
|
0.0701 log10 fold change
Standard Deviation 0.0705
|
|
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
IgM
|
-0.0018 log10 fold change
Standard Deviation 0.0459
|
-0.0202 log10 fold change
Standard Deviation 0.0674
|
0.0260 log10 fold change
Standard Deviation 0.1005
|
0.0200 log10 fold change
Standard Deviation 0.1188
|
0.0273 log10 fold change
Standard Deviation 0.1175
|
SECONDARY outcome
Timeframe: Day 50Population: All participants who completed the study and had sample available
Mean log10 concentration in Th1 (IFN-gamma) and Th2 (IL-4) cytokine responses after in vitro exposure of peripheral blood mononuclear cells (PBMCs) with AGS-v PLUS antigens seven days after mosquito feeding assessed using enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
IFN-gamma
|
0.3648 pg/ml
Standard Deviation 0.9467
|
0.7095 pg/ml
Standard Deviation 1.1809
|
1.9669 pg/ml
Standard Deviation 0.3134
|
1.7539 pg/ml
Standard Deviation 0.6509
|
1.8744 pg/ml
Standard Deviation 1.0427
|
|
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
IL4
|
-2.2435 pg/ml
Standard Deviation 1.1230
|
-2.3313 pg/ml
Standard Deviation 1.3465
|
-0.8640 pg/ml
Standard Deviation 2.1660
|
-0.7668 pg/ml
Standard Deviation 1.6473
|
-0.7570 pg/ml
Standard Deviation 2.2994
|
SECONDARY outcome
Timeframe: Day 1 and Day 50Population: All participants who completed the study and had sample available
Mean log10 fold change in Th1 (IFN-gamma) and Th2 (IL-4) cytokine responses after in vitro exposure of peripheral blood mononuclear cells (PBMCs) with AGS-v PLUS antigens from day 1 to day 50 assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 1 to day 50 is calculated by dividing the antigen titer for a specific isotype i.e. IFN-gamma at day 50 by the titer at day 1. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=7 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IL4
|
0.6819 log10 fold change
Standard Deviation 1.1847
|
0.0762 log10 fold change
Standard Deviation 0.2016
|
1.5597 log10 fold change
Standard Deviation 1.9207
|
1.2638 log10 fold change
Standard Deviation 1.3559
|
2.0330 log10 fold change
Standard Deviation 2.2454
|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IFN-gamma
|
-0.8572 log10 fold change
Standard Deviation 1.2638
|
0.1025 log10 fold change
Standard Deviation 1.2759
|
1.4584 log10 fold change
Standard Deviation 0.9659
|
1.2067 log10 fold change
Standard Deviation 1.3654
|
1.5043 log10 fold change
Standard Deviation 1.0085
|
SECONDARY outcome
Timeframe: Day 43 and Day 50Population: All participants who completed the study and had sample available
Mean log10 fold change in Th1 (IFN-gamma) and Th2 (IL-4) cytokine responses after in vitro exposure of peripheral blood mononuclear cells (PBMCs) with AGS-v PLUS antigens seven days after mosquito feeding assessed using enzyme-linked immunosorbent assay (ELISA). The fold change from day 43 to day 50 is calculated by dividing the antigen titer for a specific isotype i.e. IFN-gamma at day 50 by the titer at day 43. In order to stabilize the variance, the log10 of the fold change was used in the analyses.
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IL4
|
-0.0682 log10 fold change
Standard Deviation 1.3204
|
0.0186 log10 fold change
Standard Deviation 0.0493
|
-0.0563 log10 fold change
Standard Deviation 0.1880
|
-0.6533 log10 fold change
Standard Deviation 1.2554
|
-1.1923 log10 fold change
Standard Deviation 1.8252
|
|
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
IFN-gamma
|
0.1739 log10 fold change
Standard Deviation 1.0779
|
-0.6957 log10 fold change
Standard Deviation 1.0983
|
0.2939 log10 fold change
Standard Deviation 0.8593
|
0.2227 log10 fold change
Standard Deviation 1.0546
|
0.0855 log10 fold change
Standard Deviation 0.1705
|
SECONDARY outcome
Timeframe: Day 43Population: All participants who completed the study and underwent mosquito feeding
Mean days of Aedes aegypti and Aedes albopictus female mosquitoes survival post feeding on study participants
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean Days of Mosquitoes Survival Post Feeding
Aedes aegypti
|
6.912 Days
Standard Deviation 0.247
|
6.757 Days
Standard Deviation 0.522
|
6.783 Days
Standard Deviation 0.299
|
6.733 Days
Standard Deviation 0.301
|
6.850 Days
Standard Deviation 0.251
|
|
Mean Days of Mosquitoes Survival Post Feeding
Aedes albopictus
|
6.775 Days
Standard Deviation 0.282
|
6.671 Days
Standard Deviation 0.446
|
6.750 Days
Standard Deviation 0.446
|
6.817 Days
Standard Deviation 0.360
|
6.500 Days
Standard Deviation 0.514
|
SECONDARY outcome
Timeframe: Day 43Population: All participants who completed the study and underwent mosquito feeding
Mean number of eggs laid per Aedes aegypti and Aedes albopictus female mosquito post feeding on study participants
Outcome measures
| Measure |
Group 1: Saline Placebo
n=8 Participants
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=7 Participants
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=6 Participants
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=6 Participants
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Mean Number of Eggs Laid Per Mosquito Post Feeding
Aedes aegypti
|
41.937 eggs per mosquito
Standard Deviation 23.112
|
48.019 eggs per mosquito
Standard Deviation 13.618
|
58.865 eggs per mosquito
Standard Deviation 19.524
|
50.306 eggs per mosquito
Standard Deviation 24.500
|
44.314 eggs per mosquito
Standard Deviation 17.278
|
|
Mean Number of Eggs Laid Per Mosquito Post Feeding
Aedes albopictus
|
13.140 eggs per mosquito
Standard Deviation 8.355
|
7.225 eggs per mosquito
Standard Deviation 7.687
|
6.566 eggs per mosquito
Standard Deviation 7.151
|
5.114 eggs per mosquito
Standard Deviation 7.394
|
7.866 eggs per mosquito
Standard Deviation 8.581
|
Adverse Events
Group 1: Saline Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: AGS-v PLUS Non-Adjuvanted
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 4: AGS-v PLUS + Montanide ISA-51
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Saline Placebo
n=10 participants at risk
Participants received placebo on days 1 and 22 by subcutaneous injection
|
Group 2: AGS-v PLUS Non-Adjuvanted
n=10 participants at risk
Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection
|
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo
n=11 participants at risk
Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection
|
Group 4: AGS-v PLUS + Montanide ISA-51
n=10 participants at risk
Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection
|
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
n=10 participants at risk
Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
20.0%
2/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
20.0%
2/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Application site erythema
|
50.0%
5/10 • Number of events 9 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
36.4%
4/11 • Number of events 7 • 1 year
Tracked during clinic visits and follow up phone calls
|
40.0%
4/10 • Number of events 9 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Application site induration
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Application site pruritus
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Application site swelling
|
20.0%
2/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
18.2%
2/11 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
27.3%
3/11 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
30.0%
3/10 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Blood and lymphatic system disorders
Ecchymosis
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Endocrine disorders
Hyperglycaemia
|
20.0%
2/10 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Endocrine disorders
Hypoglycaemia
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
18.2%
2/11 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Injection site induration
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Injection site pruritus
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
18.2%
2/11 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Injection site warmth
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
18.2%
2/11 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Endocrine disorders
Polycystic ovaries
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Procedural pain
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Immune system disorders
Urticaria papular
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Vaccination site bruising
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Vaccination site erythema
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Vaccination site induration
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
27.3%
3/11 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
General disorders
Vaccination site reaction
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/11 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
18.2%
2/11 • Number of events 2 • 1 year
Tracked during clinic visits and follow up phone calls
|
30.0%
3/10 • Number of events 4 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
10.0%
1/10 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 3 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
|
Investigations
Blood glucose increased
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
9.1%
1/11 • Number of events 1 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
0.00%
0/10 • 1 year
Tracked during clinic visits and follow up phone calls
|
Additional Information
Dr. Matthew Laurens
University of Maryland School of Medicine - Center for Vaccine Development
Phone: 410-706-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place