An investigational vaccine intended to provide universal protection against mosquito-transmitted diseases has been launched by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
NIAID has launched a randomized, double-blind, placebo-controlled, phase 1 clinical trial (ClinicalTrials.gov identifier: NCT03055000) to determine the safety of an investigational vaccine, called AGS-v, which was developed by the London-based pharmaceutical company SEEK. AGS-v contains 4 synthetic proteins from mosquito salivary glands. “The proteins are designed to induce antibodies in a vaccinated individual and to cause a modified allergic response that can prevent infection when a person is bitten by a disease-carrying mosquito,” according to the news release.
The trial will enroll 60 healthy adults age 18 to 50 years, who will be assigned to receive 1 of 3 regimens as follows:
- Group 1: 2 injections of the AGS-v vaccine 21 days apart
- Group 2: 2 injections of AGS-v combined with an adjuvant (oil and water mixture to enhance immune response) 21 days apart
- Group 3: 2 placebo injections of sterile water 21 days apart
Levels of antibodies triggered by the vaccination will be examined from blood samples. After completing the vaccination schedule, participants will undergo a controlled exposure to biting female Aedes aegypti mosquitoes from NIAID’s Laboratory of Malaria and Vector Research insectary.
Once participants are bitten by the mosquitoes, the investigators will examine blood samples to see if they have a modified response to the mosquitoes’ bites as a result of the AGS-v vaccination. The mosquitoes will also be examined to assess their life cycle.
Participants will have follow-up visits every 60 days for 5 months following the mosquito exposure. A final clinic visit will occur approximately 10 months after the mosquito exposure to assess long-term safety.
“Mosquitoes cause more human disease and death than any other animal,” said NIAID Director Anthony S. Fauci, MD. “A single vaccine capable of protecting against the scourge of mosquito-borne diseases is a novel concept that, if proven successful, would be a monumental public health advance.”
The study is expected to be completed by summer 2018.
NIH begins study of vaccine to protect against mosquito-borne diseases [news release]. Bethesda, MD: National Institutes of Health; Published February 21, 2017. Accessed March 6, 2017.