The purpose of this study is to evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers.
This study will evaluate the safety and immunogenicity of AGS-v PLUS, a universal mosquito-borne disease and mosquito control vaccine, in healthy volunteers. Participants will be randomly assigned to five groups. Participants in Group 1 will receive placebo on Days 1 and 22. Participants in Group 2 will receive unadjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants in Group 3 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Day 1 and placebo on Day 22. Participants in Group 4 will receive Montanide ISA-51 adjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants in Group 5 will receive Alhydrogel® adjuvanted AGS-v PLUS vaccine on Days 1 and 22. Participants will be in the study for approximately 12 months. During this time, they will attend several study visits, which may include physical examinations, blood collection, skin biopsies, and a mosquito feeding procedure. Study staff will also follow up with participants by phone several times throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
51
Administered by subcutaneous injection
Administered by subcutaneous injection
Administered by subcutaneous injection
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States
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
Time frame: 1 year
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)
Time frame: Day 43
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.
Time frame: Day 1 and Day 43
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)
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Administered by subcutaneous injection
Time frame: Day 43
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.
Time frame: Day 1 and Day 43
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)
Time frame: Day 50
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.
Time frame: Day 1 and Day 50
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.
Time frame: Day 43 and Day 50
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)
Time frame: Day 50
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.
Time frame: Day 1 and Day 50
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.
Time frame: Day 43 and Day 50
Mean Days of Mosquitoes Survival Post Feeding
Mean days of Aedes aegypti and Aedes albopictus female mosquitoes survival post feeding on study participants
Time frame: Day 43
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
Time frame: Day 43