Mosquito-Borne Infectious Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAGS-v PLUS Vaccine
Administered by subcutaneous injection
BIOLOGICALMontanide ISA-51 Adjuvant
Administered by subcutaneous injection
BIOLOGICALAlhydrogel® Adjuvant
Administered by subcutaneous injection
BIOLOGICALSaline Placebo
Administered by subcutaneous injection
Sponsors
PepTcell Limited
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women and men who are greater than or equal to 18 and less than or equal to 50 years of age. * Willingness to complete all study visits and comply with all study requirements. * A male participant is eligible for the study if he agrees to practicing abstinence or using a condom with spermicide plus an acceptable form of contraception (see inclusion criteria below) being used by any female partner from 4 weeks before study start to 12 weeks after the second vaccine administration. * A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following: * Of non-child bearing potential (i.e., women who have had a hysterectomy or tubal ligation, or are postmenopausal, as defined by no menses in greater than or equal to 1 year). * Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks before study initiation and 12 weeks after the second vaccine administration. Acceptable methods of contraception include a female partner who is the sole sexual partner of the female participant, a male partner who is sterile and is the sole sexual partner of the female participant, or a male partner who uses a condom with spermicide plus 1 or more of the following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of less than 1%; 4) oral contraceptives; and 5) double barrier method including diaphragm. * Willing to have samples stored for future research. * Agrees to abstain from alcohol intake for 24 hours before each study visit. * Agrees to not donate blood or blood products throughout the study. * Score greater than or equal to 70% on comprehension quiz at screening
Exclusion criteria
* Participant has any underlying or current medical condition, which, in the opinion of the Investigator, would interfere with the participation in the study. * Individual with body mass index (BMI) less than or equal to 18 and greater than or equal to 40. * Participants who have a clinically significant (as determined by the PI or designee) baseline Grade 1 or greater toxicity, or any Grade 2 or greater toxicity (regardless of clinical significance) by the toxicity table. * Receipt of blood or blood products including immunoglobulin within 3 months before enrollment. * Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) before enrollment. * Receipt of any unlicensed vaccine within 6 months before enrollment. * Participated in study NCT03055000 testing safety and immunogenicity of AGS-v. * Self-reported or known history of alcoholism or drug abuse within 6 months before enrollment. * Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI or designee to be a contraindication to protocol participation. * History of a previous severe allergic reaction with generalized urticaria, angioedema, anaphylaxis or anaphylactoid reaction. * Any condition or event that, in the judgment of the PI or designee, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent. * Known allergy to any vaccine component, including adjuvants. * History of severe immunization reaction. * Severe allergic reaction to mosquito bites (anaphylaxis) * Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days before study vaccination * Have taken high-dose inhaled corticosteroids\* within 30 days before each study vaccination (\* High-dose defined per age as using inhaled high dose per reference chart: https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthma\_qrg\_0\_0.pdf) * Received or plan to receive a licensed, live vaccine within 30 days before or after the study vaccination * Received or plan to receive a licensed, inactivated vaccine within 14 days before or after study vaccination * Serologic evidence of infection with HIV, hepatitis B virus, or hepatitis C virus * Ongoing chronic skin condition, or acute skin condition at the time of vaccination or mosquito feeding, except for mild eczema. * History of keloid formation after previous biopsies, lacerations, abrasions, surgeries, or other skin procedures (e.g., cosmetic piercings) that are deemed by the PI or designee to be a contraindication to protocol participation. * Pregnancy, breastfeeding, or planning to become pregnant up to one month after mosquito feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | 1 year | 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 |
| Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | Day 43 | 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) |
| Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | Day 1 and Day 43 | 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. |
| Mean log10 Concentration in Th1 and Th2 Cytokine Responses | Day 43 | 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) |
| Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | Day 1 and Day 43 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | Day 50 | 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) |
| Mean Number of Eggs Laid Per Mosquito Post Feeding | Day 43 | Mean number of eggs laid per Aedes aegypti and Aedes albopictus female mosquito post feeding on study participants |
| Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | Day 1 and Day 50 | 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. |
| Mean log10 Concentration in Th1 and Th2 Cytokine Responses | Day 50 | 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) |
| Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | Day 1 and Day 50 | 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. |
| Mean Days of Mosquitoes Survival Post Feeding | Day 43 | Mean days of Aedes aegypti and Aedes albopictus female mosquitoes survival post feeding on study participants |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Saline Placebo Participants received placebo on days 1 and 22 by subcutaneous injection | 10 |
| 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 | 10 |
| 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 | 11 |
| 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 | 10 |
| 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 | 10 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | COVID-19 pandemic restriction/closure | 2 | 3 | 5 | 2 | 3 |
Baseline characteristics
| Characteristic | Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Group 4: AGS-v PLUS + Montanide ISA-51 | Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Total | Group 1: Saline Placebo | Group 2: AGS-v PLUS Non-Adjuvanted |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 10 Participants | 51 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 10 Participants | 9 Participants | 49 Participants | 10 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 1 Participants | 21 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 5 Participants | 7 Participants | 23 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 11 participants | 10 participants | 10 participants | 51 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 5 Participants | 21 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 5 Participants | 30 Participants | 8 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 8 / 10 | 8 / 10 | 11 / 11 | 9 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: 1 year
Population: All participants who started the study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Saline Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 4 | 0 Participants |
| Group 1: Saline Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 1 | 7 Participants |
| Group 1: Saline Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 5 | 0 Participants |
| Group 1: Saline Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 2 | 3 Participants |
| Group 1: Saline Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 3 | 0 Participants |
| Group 2: AGS-v PLUS Non-Adjuvanted | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 4 | 0 Participants |
| Group 2: AGS-v PLUS Non-Adjuvanted | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 3 | 0 Participants |
| Group 2: AGS-v PLUS Non-Adjuvanted | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 2 | 2 Participants |
| Group 2: AGS-v PLUS Non-Adjuvanted | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 5 | 0 Participants |
| Group 2: AGS-v PLUS Non-Adjuvanted | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 1 | 8 Participants |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 3 | 4 Participants |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 1 | 10 Participants |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 2 | 4 Participants |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 4 | 0 Participants |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 5 | 0 Participants |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 5 | 0 Participants |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 1 | 8 Participants |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 4 | 0 Participants |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 3 | 0 Participants |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 2 | 7 Participants |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 3 | 0 Participants |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 4 | 0 Participants |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 1 | 4 Participants |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 5 | 0 Participants |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade | Grade 2 | 1 Participants |
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)
Time frame: Day 43
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.1909 pg/ml | Standard Deviation 0.6279 |
| Group 1: Saline Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -2.1753 pg/ml | Standard Deviation 1.2352 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -2.3499 pg/ml | Standard Deviation 1.2972 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.4052 pg/ml | Standard Deviation 1.1236 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.6730 pg/ml | Standard Deviation 0.9671 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -0.8076 pg/ml | Standard Deviation 2.2295 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.5934 pg/ml | Standard Deviation 0.8151 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -0.7952 pg/ml | Standard Deviation 1.7543 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | 0.4814 pg/ml | Standard Deviation 1.5686 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.5007 pg/ml | Standard Deviation 1.1989 |
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.
Time frame: Day 1 and Day 43
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0553 log10 fold change | Standard Deviation 0.1563 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | -0.0121 log10 fold change | Standard Deviation 0.0963 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | -0.0151 log10 fold change | Standard Deviation 0.0553 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.2432 log10 fold change | Standard Deviation 0.225 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.1826 log10 fold change | Standard Deviation 0.2759 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 1.1274 log10 fold change | Standard Deviation 0.7249 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.2988 log10 fold change | Standard Deviation 0.4061 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.5530 log10 fold change | Standard Deviation 0.4568 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 1.3033 log10 fold change | Standard Deviation 0.7104 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.5336 log10 fold change | Standard Deviation 0.5084 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | -0.0114 log10 fold change | Standard Deviation 0.2509 |
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.
Time frame: Day 1 and Day 43
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | -1.0560 log10 fold change | Standard Deviation 1.2765 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 0.3529 log10 fold change | Standard Deviation 0.9338 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.7983 log10 fold change | Standard Deviation 1.6906 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 0.0576 log10 fold change | Standard Deviation 0.1523 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.1645 log10 fold change | Standard Deviation 1.7015 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 1.6160 log10 fold change | Standard Deviation 1.9909 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 1.4378 log10 fold change | Standard Deviation 1.4169 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.0486 log10 fold change | Standard Deviation 1.1661 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.9757 log10 fold change | Standard Deviation 1.4482 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 3.2786 log10 fold change | Standard Deviation 1.5472 |
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)
Time frame: Day 43
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgG | 3.3425 log10 titer | Standard Deviation 0.7442 |
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgE | 2.5399 log10 titer | Standard Deviation 0.1666 |
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgM | 3.0480 log10 titer | Standard Deviation 0.3253 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgG | 3.8098 log10 titer | Standard Deviation 0.4761 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgE | 2.4628 log10 titer | Standard Deviation 0.1606 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgM | 3.0465 log10 titer | Standard Deviation 0.3513 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgG | 3.7625 log10 titer | Standard Deviation 0.6941 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgE | 2.4915 log10 titer | Standard Deviation 0.1552 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgM | 3.3010 log10 titer | Standard Deviation 0.443 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgE | 2.4414 log10 titer | Standard Deviation 0.1606 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgM | 3.4840 log10 titer | Standard Deviation 0.5158 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgG | 4.1428 log10 titer | Standard Deviation 0.4795 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgG | 3.3863 log10 titer | Standard Deviation 0.3979 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgE | 2.5058 log10 titer | Standard Deviation 0.1466 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers | IgM | 3.1993 log10 titer | Standard Deviation 0.4856 |
Secondary
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
Population: All participants who completed the study and underwent mosquito feeding
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean Days of Mosquitoes Survival Post Feeding | Aedes aegypti | 6.912 Days | Standard Deviation 0.247 |
| Group 1: Saline Placebo | Mean Days of Mosquitoes Survival Post Feeding | Aedes albopictus | 6.775 Days | Standard Deviation 0.282 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean Days of Mosquitoes Survival Post Feeding | Aedes aegypti | 6.757 Days | Standard Deviation 0.522 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean Days of Mosquitoes Survival Post Feeding | Aedes albopictus | 6.671 Days | Standard Deviation 0.446 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean Days of Mosquitoes Survival Post Feeding | Aedes aegypti | 6.783 Days | Standard Deviation 0.299 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean Days of Mosquitoes Survival Post Feeding | Aedes albopictus | 6.750 Days | Standard Deviation 0.446 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean Days of Mosquitoes Survival Post Feeding | Aedes albopictus | 6.817 Days | Standard Deviation 0.36 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean Days of Mosquitoes Survival Post Feeding | Aedes aegypti | 6.733 Days | Standard Deviation 0.301 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean Days of Mosquitoes Survival Post Feeding | Aedes aegypti | 6.850 Days | Standard Deviation 0.251 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean Days of Mosquitoes Survival Post Feeding | Aedes albopictus | 6.500 Days | Standard Deviation 0.514 |
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)
Time frame: Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.3648 pg/ml | Standard Deviation 0.9467 |
| Group 1: Saline Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -2.2435 pg/ml | Standard Deviation 1.123 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.7095 pg/ml | Standard Deviation 1.1809 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -2.3313 pg/ml | Standard Deviation 1.3465 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.9669 pg/ml | Standard Deviation 0.3134 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -0.8640 pg/ml | Standard Deviation 2.166 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -0.7668 pg/ml | Standard Deviation 1.6473 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.7539 pg/ml | Standard Deviation 0.6509 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.8744 pg/ml | Standard Deviation 1.0427 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Concentration in Th1 and Th2 Cytokine Responses | IL4 | -0.7570 pg/ml | Standard Deviation 2.2994 |
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.
Time frame: Day 1 and Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0174 log10 fold change | Standard Deviation 0.0491 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | -0.0139 log10 fold change | Standard Deviation 0.0967 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | -0.0254 log10 fold change | Standard Deviation 0.0552 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.2309 log10 fold change | Standard Deviation 0.2134 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.1623 log10 fold change | Standard Deviation 0.2306 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 1.1874 log10 fold change | Standard Deviation 0.7482 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.3247 log10 fold change | Standard Deviation 0.3746 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0161 log10 fold change | Standard Deviation 0.0395 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.6928 log10 fold change | Standard Deviation 0.5505 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 1.4047 log10 fold change | Standard Deviation 0.8537 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.5295 log10 fold change | Standard Deviation 0.4994 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.0204 log10 fold change | Standard Deviation 0.325 |
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.
Time frame: Day 43 and Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | -0.0379 log10 fold change | Standard Deviation 0.1072 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | -0.0018 log10 fold change | Standard Deviation 0.0459 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | -0.0103 log10 fold change | Standard Deviation 0.0102 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | -0.0122 log10 fold change | Standard Deviation 0.0328 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | -0.0202 log10 fold change | Standard Deviation 0.0674 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.0601 log10 fold change | Standard Deviation 0.0705 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.0260 log10 fold change | Standard Deviation 0.1005 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0161 log10 fold change | Standard Deviation 0.0395 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.0200 log10 fold change | Standard Deviation 0.1188 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.1256 log10 fold change | Standard Deviation 0.0968 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 0.0701 log10 fold change | Standard Deviation 0.0705 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 0.0000 log10 fold change | Standard Deviation 0 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 0.0273 log10 fold change | Standard Deviation 0.1175 |
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.
Time frame: Day 1 and Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | -0.8572 log10 fold change | Standard Deviation 1.2638 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 0.6819 log10 fold change | Standard Deviation 1.1847 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.1025 log10 fold change | Standard Deviation 1.2759 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 0.0762 log10 fold change | Standard Deviation 0.2016 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.4584 log10 fold change | Standard Deviation 0.9659 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 1.5597 log10 fold change | Standard Deviation 1.9207 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 1.2638 log10 fold change | Standard Deviation 1.3559 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.2067 log10 fold change | Standard Deviation 1.3654 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 1.5043 log10 fold change | Standard Deviation 1.0085 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 2.0330 log10 fold change | Standard Deviation 2.2454 |
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.
Time frame: Day 43 and Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.1739 log10 fold change | Standard Deviation 1.0779 |
| Group 1: Saline Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | -0.0682 log10 fold change | Standard Deviation 1.3204 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | -0.6957 log10 fold change | Standard Deviation 1.0983 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | 0.0186 log10 fold change | Standard Deviation 0.0493 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.2939 log10 fold change | Standard Deviation 0.8593 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | -0.0563 log10 fold change | Standard Deviation 0.188 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | -0.6533 log10 fold change | Standard Deviation 1.2554 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.2227 log10 fold change | Standard Deviation 1.0546 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IFN-gamma | 0.0855 log10 fold change | Standard Deviation 0.1705 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Fold Change in Th1 and Th2 Cytokine Responses | IL4 | -1.1923 log10 fold change | Standard Deviation 1.8252 |
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)
Time frame: Day 50
Population: All participants who completed the study and had sample available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 2.502 log10 titer | Standard Deviation 0.1362 |
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 3.0461 log10 titer | Standard Deviation 0.3381 |
| Group 1: Saline Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 3.3322 log10 titer | Standard Deviation 0.7409 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 3.7976 log10 titer | Standard Deviation 0.4694 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 2.4628 log10 titer | Standard Deviation 0.1606 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 3.0263 log10 titer | Standard Deviation 0.3157 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 3.8225 log10 titer | Standard Deviation 0.7273 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 2.4915 log10 titer | Standard Deviation 0.1552 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 3.3270 log10 titer | Standard Deviation 0.4327 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 2.4074 log10 titer | Standard Deviation 0.1475 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 3.7576 log10 titer | Standard Deviation 0.2931 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 4.4132 log10 titer | Standard Deviation 0.4667 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgG | 3.4214 log10 titer | Standard Deviation 0.3945 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgE | 2.4915 log10 titer | Standard Deviation 0.1552 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer | IgM | 3.2060 log10 titer | Standard Deviation 0.4878 |
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
Time frame: Day 43
Population: All participants who completed the study and underwent mosquito feeding
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Saline Placebo | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes aegypti | 41.937 eggs per mosquito | Standard Deviation 23.112 |
| Group 1: Saline Placebo | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes albopictus | 13.140 eggs per mosquito | Standard Deviation 8.355 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes aegypti | 48.019 eggs per mosquito | Standard Deviation 13.618 |
| Group 2: AGS-v PLUS Non-Adjuvanted | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes albopictus | 7.225 eggs per mosquito | Standard Deviation 7.687 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes aegypti | 58.865 eggs per mosquito | Standard Deviation 19.524 |
| Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes albopictus | 6.566 eggs per mosquito | Standard Deviation 7.151 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes albopictus | 5.114 eggs per mosquito | Standard Deviation 7.394 |
| Group 4: AGS-v PLUS + Montanide ISA-51 | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes aegypti | 50.306 eggs per mosquito | Standard Deviation 24.5 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes aegypti | 44.314 eggs per mosquito | Standard Deviation 17.278 |
| Group 5: AGS-v PLUS + Alhydrogel® Adjuvant | Mean Number of Eggs Laid Per Mosquito Post Feeding | Aedes albopictus | 7.866 eggs per mosquito | Standard Deviation 8.581 |