{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T08:56:54Z","timestamp":1776416214617,"version":"3.51.2"},"reference-count":24,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T00:00:00Z","timestamp":1776384000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Biological E. Limited"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>Biological E\u2019s BEVAC\u00ae is a recombinant DNA hepatitis B vaccine that has been used in India for more than a decade in routine early-life immunization and has recently been prequalified by the World Health Organization (WHO). This multicentre, single-blind, parallel-group, randomized phase IV trial, conducted at seven study sites in India, compared the immunogenicity and safety of BEVAC\u00ae with a licensed comparator vaccine (GeneVac-B\u00ae, Serum Institute of India Pvt. Ltd, Pune, India.) in healthy term neonates and infants. Participants received three 0.5 mL doses administered intramuscularly at birth (within 24 h), 6 weeks of age, and 14 weeks of age. The primary endpoint was seroprotection (anti-HBs IgG \u226510 mIU\/mL) at 28 days after the third dose (Day 126), compared using a non-inferiority margin of \u221210%. Secondary endpoints included safety and tolerability outcomes through Day 126. A total of 468 neonates were randomized (234 per group), of whom 44% were female. At Day 126, seroprotection rates were 98.2% (95% CI: 95.39, 99.50) with BEVAC\u00ae and 99.1% (95% CI: 96.78, 99.89) with the comparator; the between-group difference was \u22120.9% (95% CI: \u22123.09, 1.24), meeting the prespecified non-inferiority criterion. Solicited adverse events within 7 days after any dose occurred in 29.1% (95% CI: 23.3, 35.3) of BEVAC\u00ae recipients and 35.0% (95% CI: 28.9, 41.5) of comparator recipients, most commonly pyrexia, injection-site pain, and swelling; all were mild-to-moderate. No serious adverse events were reported. BEVAC\u00ae demonstrated non-inferior immunogenicity to the licensed comparator and a comparable safety profile.<\/jats:p>","DOI":"10.3390\/v18040472","type":"journal-article","created":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T07:48:12Z","timestamp":1776412092000},"page":"472","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Immunogenicity and Safety of Biological E\u2019s Monovalent rDNA Hepatitis B Vaccine (BEVAC\u00ae) in Neonates and Infants: A Multicentre, Randomized, Phase IV Non-Inferiority Trial"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9099-420X","authenticated-orcid":false,"given":"Subhash","family":"Thuluva","sequence":"first","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Subbareddy","family":"Gunneri","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6116-4959","authenticated-orcid":false,"given":"Siddalingaiah","family":"Ningaiah","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vijay","family":"Yerroju","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rammohan Reddy","family":"Mogulla","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chirag","family":"Dhar","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-7614-4026","authenticated-orcid":false,"given":"Kamal","family":"Thammireddy","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-2262-5454","authenticated-orcid":false,"given":"Raju","family":"Esanakarra","sequence":"additional","affiliation":[{"name":"Biological E Limited, Hyderabad 500 020, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pradeep","family":"Nanjappa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Cheluvamba Hospital, Mysore Medical College & Research Institute, Mysore 570 001, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Niranjana S.","family":"Mahantshetti","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi 590 010, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,4,17]]},"reference":[{"key":"ref_1","unstructured":"World Health Organization (2025). 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Viral Hepat."}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/18\/4\/472\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T07:57:33Z","timestamp":1776412653000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/18\/4\/472"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,17]]},"references-count":24,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2026,4]]}},"alternative-id":["v18040472"],"URL":"https:\/\/doi.org\/10.3390\/v18040472","relation":{},"ISSN":["1999-4915"],"issn-type":[{"value":"1999-4915","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,17]]}}}