| Primary | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | 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 | All participants who started the study | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 | | OG004 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00010
- OG00110
- OG00211
- OG003
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| | Title | Denominators | Categories |
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| Grade 1 | | |
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| Primary | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | 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) | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 titer | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Primary | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 1 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | |
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| Primary | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | 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) | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | pg/ml | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Primary | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 1 and Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 |
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| Secondary | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | 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) | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 titer | | Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Secondary | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 1 and Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | |
|
| Secondary | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 43 and Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | 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) | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | pg/ml | | Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | Group 4: AGS-v PLUS + Montanide ISA-51 | |
|
| Secondary | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 1 and Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | 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. | All participants who completed the study and had sample available | Posted | | Mean | Standard Deviation | log10 fold change | | Day 43 and Day 50 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 |
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| Secondary | Mean Days of Mosquitoes Survival Post Feeding | Mean days of Aedes aegypti and Aedes albopictus female mosquitoes survival post feeding on study participants | All participants who completed the study and underwent mosquito feeding | Posted | | Mean | Standard Deviation | Days | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
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| Secondary | Mean Number of Eggs Laid Per Mosquito Post Feeding | Mean number of eggs laid per Aedes aegypti and Aedes albopictus female mosquito post feeding on study participants | All participants who completed the study and underwent mosquito feeding | Posted | | Mean | Standard Deviation | eggs per mosquito | | Day 43 | | | | ID | Title | Description |
|---|
| OG000 | Group 1: Saline Placebo | Participants received placebo on days 1 and 22 by subcutaneous injection | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|