Evaluating the Safety and Immunogenicity of AGS-v PLUS, a Universal Mosquito-Borne Disease and Mosquito Control Vaccine
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
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedResults Posted
Study results publicly available
April 28, 2022
CompletedApril 28, 2022
March 1, 2022
8 months
July 1, 2019
March 22, 2022
April 25, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
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)
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.
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)
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.
Day 1 and Day 43
Secondary Outcomes (8)
Mean log10 Titer in Serum AGS-v PLUS Specific Immunoglobulin Titer
Day 50
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 Titer
Day 43 and Day 50
Mean log10 Concentration in Th1 and Th2 Cytokine Responses
Day 50
Mean log10 Fold Change in Th1 and Th2 Cytokine Responses
Day 1 and Day 50
- +3 more secondary outcomes
Study Arms (5)
Group 1: Saline Placebo
PLACEBO COMPARATORParticipants received placebo on days 1 and 22 by subcutaneous injection
Group 2: AGS-v PLUS Non-Adjuvanted
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants received 1012 µg of AGS-v PLUS and Alhydrogel® on days 1 and 22 by subcutaneous injection
Interventions
Administered by subcutaneous injection
Administered by subcutaneous injection
Administered by subcutaneous injection
Administered by subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Matthew Laurens
- Organization
- University of Maryland School of Medicine - Center for Vaccine Development
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew B. Laurens, MD, MPH
University of Maryland, Baltimore
- PRINCIPAL INVESTIGATOR
Matthew J. Memoli, MD, MS
National Institute of Allergy and Infectious Diseases (NIAID)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 5, 2019
Study Start
July 8, 2019
Primary Completion
March 3, 2020
Study Completion
February 23, 2021
Last Updated
April 28, 2022
Results First Posted
April 28, 2022
Record last verified: 2022-03