{"doi":"10.1093/infdis/jiae148","title":"A Phase 1, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin) Vaccine in Healthy US Adults","abstract":"BACKGROUND: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality. METHODS: We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine to placebo) trial of 30 µg HEV-239 (Hecolin, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM). RESULTS: Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at 1 month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked 1 month following the second dose (geometric mean concentration [GMC], 6.16; 95% confidence interval [CI], 4.40-8.63), was boosted with the third dose (GMC, 11.50; 95% CI, 7.90-16.75) and persisted through 6 months. CONCLUSIONS: HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults. CLINICAL TRIALS REGISTRATION: NCT03827395.","journal":"The Journal of Infectious Diseases","year":2024,"id":452598,"datarank":0.7066321898484131,"base_score":2.4849066497880004,"endowment":2.4849066497880004,"self_citation_contribution":0.37273599746820013,"citation_network_contribution":0.33389619238021306,"self_endowment_contribution":0.37273599746820013,"citer_contribution":0.33389619238021306,"corpus_percentile":null,"corpus_rank":null,"citation_count":11,"citer_count":11,"citers_with_citation_signal":9,"citers_with_endowment":9,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9382,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03827395"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":94488,"name":"Christina A. Rostad","orcid":"0000-0001-8439-0592","position":1,"is_corresponding":false},{"id":1028933,"name":"L. Nolan","orcid":null,"position":2,"is_corresponding":false},{"id":616979,"name":"Etza Peters","orcid":null,"position":3,"is_corresponding":false},{"id":384284,"name":"Jennifer Kleinhenz","orcid":null,"position":4,"is_corresponding":false},{"id":848590,"name":"Jacob D. Sherman","orcid":"0009-0002-2597-7654","position":5,"is_corresponding":false},{"id":1196383,"name":"Ashley Tippett","orcid":null,"position":6,"is_corresponding":false},{"id":1275291,"name":"James Wai Kuo Shih","orcid":null,"position":7,"is_corresponding":false},{"id":409698,"name":"İnci Yıldırım","orcid":"0000-0002-8631-0020","position":8,"is_corresponding":false},{"id":1275292,"name":"Vivien Agbakoba","orcid":null,"position":9,"is_corresponding":false},{"id":846575,"name":"Tatiana Beresnev","orcid":"0000-0001-9543-0107","position":10,"is_corresponding":false},{"id":1026728,"name":"Cassandra Ballou","orcid":"0000-0003-0097-5599","position":11,"is_corresponding":false},{"id":288016,"name":"Satoshi Kamidani","orcid":"0000-0001-6829-0700","position":12,"is_corresponding":false},{"id":384283,"name":"Vinit Karmali","orcid":null,"position":13,"is_corresponding":false},{"id":288421,"name":"Muktha S. Natrajan","orcid":"0000-0003-1854-0382","position":14,"is_corresponding":false},{"id":226165,"name":"Erin M. Scherer","orcid":"0000-0002-8794-1932","position":15,"is_corresponding":false},{"id":104987,"name":"Nadine Rouphael","orcid":"0000-0002-2512-7919","position":16,"is_corresponding":false},{"id":94484,"name":"Evan J. Anderson","orcid":"0000-0002-1576-4420","position":17,"is_corresponding":false},{"id":338069,"name":"Carol Kao","orcid":null,"position":0,"is_corresponding":true}],"reference_count":19,"raw_metadata":null,"created_at":"2026-07-19T02:02:54.415477Z","pmid":"38536442","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":[]}