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

Completed · Phase 1 · Has a placebo group

Conditions studied: Mosquito-Borne Disease

In brief

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.

Key facts

Study ID

NCT03055000

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

49

Starts

2017-02-15

Expected to finish

2018-12-28

Last updated by the study team

2020-08-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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) baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table.
• Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
• Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
• Receipt of any unlicensed vaccine within 6 months prior to enrollment.
• Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine/serum test for drugs of abuse at screening
• Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI 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, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent.
• Has a known allergy to any of the components of the vaccine.
• Has a history of severe immunization reaction.
• Has a severe allergic reaction to mosquito bites

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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