{"doi":"10.1016/j.ebiom.2022.104375","title":"Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases: A randomized, double-blind, placebo-controlled Phase 1 trial","abstract":"BACKGROUND: Immunity 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. METHODS: We 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. FINDINGS: Between 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. INTERPRETATION: AGS-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. FUNDING: UK Department of Health and Social Care.","journal":"EBioMedicine","year":2022,"id":254919,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":21,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9517,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":264853,"name":"Megan Birkhold","orcid":"0000-0002-5746-1321","position":1,"is_corresponding":false},{"id":902194,"name":"Mara Short","orcid":"0000-0002-9756-865X","position":2,"is_corresponding":false},{"id":468897,"name":"Timothy R. 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Valenzuela","orcid":"0000-0002-5589-9450","position":8,"is_corresponding":false},{"id":295533,"name":"Sally Hunsberger","orcid":"0000-0002-4251-5622","position":9,"is_corresponding":false},{"id":344858,"name":"Allyson Mateja","orcid":"0000-0002-2810-478X","position":10,"is_corresponding":false},{"id":296902,"name":"Gregory Stoloff","orcid":null,"position":11,"is_corresponding":false},{"id":295525,"name":"Olga Pleguezuelos","orcid":"0000-0002-7099-5002","position":12,"is_corresponding":false},{"id":233146,"name":"Matthew J. Memoli","orcid":"0000-0001-6393-5178","position":13,"is_corresponding":false},{"id":429806,"name":"Matthew B. Laurens","orcid":"0000-0003-3874-581X","position":14,"is_corresponding":false},{"id":524908,"name":"DeAnna Friedman-Klabanoff","orcid":"0000-0003-0373-4643","position":0,"is_corresponding":true}],"reference_count":20,"raw_metadata":null,"created_at":"2026-07-19T00:25:08.518416Z","pmid":"36436281","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}