Mosquito-Borne Infectious DiseasesPhase 1NCT04009824

Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

A Phase 1 study testing AGS-v PLUS Vaccine, Montanide ISA-51 Adjuvant and Alhydrogel® Adjuvant in people with Mosquito-Borne Infectious Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Mosquito-Borne Infectious Diseases
What is being tested?: AGS-v PLUS Vaccine, Montanide ISA-51 Adjuvant and Alhydrogel® Adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2019to 23 Feb 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 10Show fewer

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

Who cannot join

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.

Show all 22Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine

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.

Read the 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.

Conditions: Mosquito-Borne Infectious Diseases
Being tested: AGS-v PLUS Vaccine, Montanide ISA-51 Adjuvant, Alhydrogel® Adjuvant, Saline Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGS-v PLUS VaccineBiological
Administered by subcutaneous injection
Montanide ISA-51 AdjuvantBiological
Administered by subcutaneous injection
Alhydrogel® AdjuvantBiological
Administered by subcutaneous injection
Saline PlaceboBiological
Administered by subcutaneous injection

Study groups in NCT04009824
Study group	Role	What they receive
Group 1: Saline Placebo	Placebo comparator	Participants received placebo on days 1 and 22 by subcutaneous injection Receives: Biological: Saline Placebo
Group 2: AGS-v PLUS Non-Adjuvanted	Experimental	Participants received 1012 µg of unadjuvanted AGS-v PLUS vaccine on days 1 and 22 by subcutaneous injection Receives: Biological: AGS-v PLUS Vaccine
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo	Experimental	Participants received 1012 µg of AGS-v PLUS and Montanide ISA-51 on day 1 and placebo on day 22 by subcutaneous injection Receives: Biological: AGS-v PLUS Vaccine; Biological: Montanide ISA-51 Adjuvant; Biological: Saline Placebo
Group 4: AGS-v PLUS + Montanide ISA-51	Experimental	Participants received 1012 µg of AGS-v PLUS + Montanide ISA-51 on days 1 and 22 by subcutaneous injection Receives: Biological: AGS-v PLUS Vaccine; Biological: Montanide ISA-51 Adjuvant
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant	Experimental	Participants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection Receives: Biological: AGS-v PLUS Vaccine; Biological: Alhydrogel® Adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Day 1 and Day 43

Secondary outcomes (8)

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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201923 Feb 2021

First posted5 Jul 2019
Study start8 Jul 2019
Primary completion3 Mar 2020
Study completion23 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mosquito-Borne Infectious DiseasesStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04009824
Sponsor's protocol ID: AGS-v PLUS
Status last verified: Mar 2022
First submitted: 1 Jul 2019
Last updated: 28 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled, Single-Center, Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
ClinicalTrials.gov ID: NCT04009824
Acronym / sponsor ID: AGS-v PLUS
Conditions: Mosquito-Borne Infectious Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: PepTcell Limited
Study start: 8 Jul 2019 (actual)
Primary completion: 3 Mar 2020 (actual)
Study completion: 23 Feb 2021 (actual)
First posted: 5 Jul 2019 (actual)
Results: Posted 28 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Group 1: Saline Placebo	Placebo comparator	Biological: Saline PlaceboParticipants received placebo on days 1 and 22 by subcutaneous injection
Group 2: AGS-v PLUS Non-Adjuvanted	Experimental	Biological: AGS-v PLUS VaccineParticipants 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	Experimental	Biological: AGS-v PLUS Vaccine, Biological: Montanide ISA-51 Adjuvant, Biological: Saline PlaceboParticipants 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	Experimental	Biological: AGS-v PLUS Vaccine, Biological: Montanide ISA-51 AdjuvantParticipants 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	Experimental	Biological: AGS-v PLUS Vaccine, Biological: Alhydrogel® AdjuvantParticipants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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:
Willing to have samples stored for future research.

Key exclusion criteria (22 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGS-v PLUS VaccineAdministered by subcutaneous injection	Biological	Group 2: AGS-v PLUS Non-Adjuvanted, 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
Montanide ISA-51 AdjuvantAdministered by subcutaneous injection	Biological	Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo, Group 4: AGS-v PLUS + Montanide ISA-51
Alhydrogel® AdjuvantAdministered by subcutaneous injection	Biological	Group 5: AGS-v PLUS + Alhydrogel® Adjuvant
Saline PlaceboAdministered by subcutaneous injection	Biological	Group 1: Saline Placebo, Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo

Primary outcome

Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

8 secondary outcomes

Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer
Time frame: Day 50
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
Time frame: Day 1 and Day 50
Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer
Time frame: Day 43 and Day 50
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
Time frame: Day 50
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
Time frame: Day 1 and Day 50
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
Time frame: Day 43 and Day 50
Mean Days of Mosquitoes Survival Post Feeding
Time frame: Day 43
Mean Number of Eggs Laid Per Mosquito Post Feeding
Time frame: Day 43

Results and safety

Results posted to the registry on 28 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Saline Placebo	10	8
Group 2: AGS-v PLUS Non-Adjuvanted	10	7
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo	11	6
Group 4: AGS-v PLUS + Montanide ISA-51	10	8
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant	10	7

Primary outcome: Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Group 1: Saline Placebo n = 10	Group 2: AGS-v PLUS Non-Adjuvanted n = 10	Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo n = 11	Group 4: AGS-v PLUS + Montanide ISA-51 n = 10	Group 5: AGS-v PLUS + Alhydrogel® Adjuvant n = 10
Grade 1	7	8	10	8	4
Grade 2	3	2	4	7	1
Grade 3	0	0	4	0	0
Grade 4	0	0	0	0	0
Grade 5	0	0	0	0	0

Population analysed: All participants who started the study

Primary outcome: Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titers

Time frame: Day 43. Mean (Standard Deviation). Unit: log10 titer

Measure	Group 1: Saline Placebo n = 8	Group 2: AGS-v PLUS Non-Adjuvanted n = 7	Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo n = 6	Group 4: AGS-v PLUS + Montanide ISA-51 n = 8	Group 5: AGS-v PLUS + Alhydrogel® Adjuvant n = 7
IgE	2.5399 (0.1666)	2.4628 (0.1606)	2.4915 (0.1552)	2.4414 (0.1606)	2.5058 (0.1466)
IgG	3.3425 (0.7442)	3.8098 (0.4761)	3.7625 (0.6941)	4.1428 (0.4795)	3.3863 (0.3979)
IgM	3.0480 (0.3253)	3.0465 (0.3513)	3.3010 (0.4430)	3.4840 (0.5158)	3.1993 (0.4856)

Population analysed: All participants who completed the study and had sample available

Primary outcome: Mean log10 Fold Change in Serum AGS-v PLUS Specific Immunoglobulin Titer

Time frame: Day 1 and Day 43. Mean (Standard Deviation). Unit: log10 fold change

Measure	Group 1: Saline Placebo n = 8	Group 2: AGS-v PLUS Non-Adjuvanted n = 7	Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo n = 6	Group 4: AGS-v PLUS + Montanide ISA-51 n = 8	Group 5: AGS-v PLUS + Alhydrogel® Adjuvant n = 7
IgE	0.0553 (0.1563)	0.0000 (0.0000)	0.0000 (0.0000)	0.0000 (0.0000)	0.0000 (0.0000)
IgG	-0.0151 (0.0553)	0.2432 (0.2250)	1.1274 (0.7249)	1.3033 (0.7104)	0.5336 (0.5084)
IgM	-0.0121 (0.0963)	0.1826 (0.2759)	0.2988 (0.4061)	0.5530 (0.4568)	-0.0114 (0.2509)

Population analysed: All participants who completed the study and had sample available

Primary outcome: Mean log10 Concentration in Th1 and Th2 Cytokine Responses

Time frame: Day 43. Mean (Standard Deviation). Unit: pg/ml

Measure	Group 1: Saline Placebo n = 8	Group 2: AGS-v PLUS Non-Adjuvanted n = 7	Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo n = 6	Group 4: AGS-v PLUS + Montanide ISA-51 n = 8	Group 5: AGS-v PLUS + Alhydrogel® Adjuvant n = 7
IFN-gamma	0.1909 (0.6279)	1.4052 (1.1236)	1.6730 (0.9671)	1.5934 (0.8151)	1.5007 (1.1989)
IL4	-2.1753 (1.2352)	-2.3499 (1.2972)	-0.8076 (2.2295)	-0.7952 (1.7543)	0.4814 (1.5686)

Population analysed: All participants who completed the study and had sample available

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Saline Placebo	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Group 2: AGS-v PLUS Non-Adjuvanted	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Group 3: AGS-v PLUS + Adjuvant Montanide ISA-51 + Placebo	0 of 11 (0%)	11 of 11 (100%)	0 of 11
Group 4: AGS-v PLUS + Montanide ISA-51	0 of 10 (0%)	9 of 10 (90%)	0 of 10
Group 5: AGS-v PLUS + Alhydrogel® Adjuvant	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew B. Laurens, MD, MPH principal investigator

University of Maryland, Baltimore

Matthew J. Memoli, MD, MS principal investigator

National Institute of Allergy and Infectious Diseases (NIAID)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Severity of Treatment Emergent Adverse Events (AEs) by Grade (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009824.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.