NDLI: Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases: A randomized, double-blind, placebo-controlled Phase 1 trial.

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Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases: A randomized, double-blind, placebo-controlled Phase 1 trial.

Content Provider	Europe PMC
Author	Friedman-Klabanoff, DeAnna J. Birkhold, Megan Short, Mara T. Wilson, Timothy R. Meneses, Claudio R. Lacsina, Joshua R. Oliveira, Fabiano Kamhawi, Shaden Valenzuela, Jesus G. Hunsberger, Sally Mateja, Allyson Stoloff, Gregory Pleguezuelos, Olga Memoli, Matthew J. Laurens, Matthew B.
Copyright Year	2022
Abstract	SummaryBackgroundImmunity to mosquito salivary proteins could provide protection against multiple mosquito-borne diseases and significantly impact public health. We evaluated the safety and immunogenicity of AGS-v PLUS, a mosquito salivary peptide vaccine, in healthy adults 18–50 years old.MethodsWe conducted a randomized, double-blind, placebo-controlled Phase 1 study of AGS-v PLUS administered subcutaneously on Days 1 and 22 at the Center for Vaccine Development and Global Health, Baltimore, MD, USA. Participants were block randomized 1:1:1:1:1 to two doses saline placebo, two doses AGS-v PLUS, AGS-v PLUS/ISA-51 and saline placebo, two doses AGS-v PLUS/ISA-51, or two doses AGS-v PLUS/Alhydrogel. Primary endpoints were safety (all participants receiving ≥1 injection) and antibody and cytokine responses (all participants with day 43 samples), analysed by intention to treat.FindingsBetween 26 August 2019 and 25 February 2020, 51 participants were enrolled and randomized, 11 into the single dose AGS-v PLUS/ISA-51 group and ten in other groups. Due to COVID-19, 15 participants did not return for day 43 samplings. Participants experienced no treatment-emergent or serious adverse events. All solicited symptoms in 2/10 placebo recipients and 22/41 AGS-v PLUS recipients after dose one and 1/10 placebo recipients and 22/41 AGS-v PLUS recipients after dose two were mild/moderate except for one severe fever the day after vaccination (placebo group). Only injection site pain was more common in vaccine groups (15/51 after dose 1 and 11/51 after dose 2) versus placebo. Compared to placebo, all vaccine groups had significantly greater fold change in anti-AGS-v PLUS IgG and IFN-ɣ from baseline.InterpretationAGS-v PLUS had favourable safety profile and induced robust immune responses. Next steps will determine if findings translate into clinical efficacy against mosquito-borne diseases.Funding10.13039/501100000276UK Department of Health and Social Care.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC9700263&blobtype=pdf
Journal	eBioMedicine
Volume Number	86
DOI	10.1016/j.ebiom.2022.104375
PubMed Central reference number	PMC9700263
PubMed reference number	36436281
e-ISSN	23523964
Language	English
Publisher	Elsevier
Publisher Date	2022-11-24
Access Restriction	Open
Rights License	This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). © 2022 The Authors
Subject Keyword	Mosquito-borne diseases Vector-borne viruses Mosquito-borne disease vaccine
Content Type	Text
Resource Type	Article
Subject	Medicine Biochemistry, Genetics and Molecular Biology

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