Mosquito-Borne Disease clinical trials

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

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.