Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial

Lancet
Jessica E ManningMatthew J Memoli

Abstract

In animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans. In this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by ex...Continue Reading

Citations

Aug 28, 2020·Frontiers in Cellular and Infection Microbiology·David GuerreroDorothée Missé
Mar 20, 2021·Risk Management and Healthcare Policy·Navneet AroraAshok K Pannu
May 1, 2021·Vaccines·Olayinka OlajigaBerlin Londono-Renteria
May 27, 2021·The Journal of Venomous Animals and Toxins Including Tropical Diseases·Claudia Demarta-Gatsi, Salah Mécheri
Jun 22, 2021·Expert Review of Vaccines·Velasco CimicaTimothy T Stedman

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