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Safety and Immunogenicity of a First-in-Human Mosquito Saliva Peptide Vaccine

NCT03055000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-08-11

Study results available
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Summary

Background:

Mosquitos carry diseases that cause major health problems and death worldwide. The AGS-v vaccine targets proteins in mosquito saliva. This may help prevent many mosquito-borne diseases. It might also reduce the lifespan of the mosquito that bites the vaccinated person.

Objective:

To see if the AGS-v vaccine is safe in humans and how it affects the immune system.

Eligibility:

Healthy adults ages 18-50

Design:

Participants will be screened another study.

Participants will be randomly assigned to get either the vaccine with a booster vaccine, the vaccine without the booster, or a placebo. These are given through a needle in the upper arm.

Participants will have visits that include medical history, physical exam, and blood and urine tests:

Baseline: They will get the vaccine and be monitored for 2 hours.

Follow-up visits 1 and 2 weeks after baseline.

Visit 3 weeks after baseline: They will get the booster and be monitored for 2 hours.

Follow-up visits 1 and 2 weeks after booster visit.

Visit 3-5 weeks after booster visit: This includes mosquito feeding. Mosquitos grown in the lab will be allowed to bite the arm. Blood will be drawn 4 times in the 3 hours after the feeding.

Phone follow-up a few days after the mosquito feeding.

After the feeding visit, 5 follow-up visits about every 2 months

Participants will keep a symptom diary for 7 days after each vaccine. They will record their temperature. They will measure any redness around the injection site. They will document and if possible photograph any mosquito bites they get.

Conditions

  • Mosquito-Borne Disease

Interventions

BIOLOGICAL

AGS-v

AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21

BIOLOGICAL

AGS-v + adjuvant

ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21

OTHER

Placebo

WFI (0.5mL) on Day 0 and Day 21

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-12-28
Completion
2018-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055000 on ClinicalTrials.gov