Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults

Summary

This study is a double-blind randomized controlled trial designed to establish the non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.

Timeline

Start

2017-12-13

Primary completion

2019-04-08

Completion

2019-04-08

Outcome

Met primary endpoint

paper difference 14·9%, 95% CI 11·2-18·6), showing non-inferiority in the per-protocol set. PMID 33989539 ↗

paper difference 16·4%, 95% CI 12·2-20·7), showing superiority in the full analysis set. PMID 33989539 ↗

Publications

• Berthoud TK, Ahmed T, Nadia W, Petrov I, Yang L, Colledge D, Hammond R, Soare C, Ontsouka B, Plaskin D, Anderson DE, Diaz-Mitoma F. A three antigen hepatitis B vaccine induces T cells to Pres1 and Pres2 which correlate with anti HBs antibody titers: An investigation into the immunological mechanisms contributing to high anti-HBs titers. Vaccine. 2025 Jan 1;43(Pt 2):126513. doi: 10.1016/j.vaccine.2024.126513. Epub 2024 Nov 12.
• Talbird SE, Anderson SA, Nossov M, Beattie N, Rak AT, Diaz-Mitoma F. Cost-effectiveness of a 3-antigen versus single-antigen vaccine for the prevention of hepatitis B in adults in the United States. Vaccine. 2023 May 26;41(23):3506-3517. doi: 10.1016/j.vaccine.2023.04.022. Epub 2023 May 3.
• Vesikari T, Langley JM, Segall N, Ward BJ, Cooper C, Poliquin G, Smith B, Gantt S, McElhaney JE, Dionne M, van Damme P, Leroux-Roels I, Leroux-Roels G, Machluf N, Spaans JN, Yassin-Rajkumar B, Anderson DE, Popovic V, Diaz-Mitoma F; PROTECT Study Group. Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial. Lancet Infect Dis. 2021 Sep;21(9):1271-1281. doi: 10.1016/S1473-3099(20)30780-5. Epub 2021 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Engerix-B	Vaccine	20 ug	Intramuscular
Subject	Sci-B-Vac	Vaccine	10 ug	Intramuscular

Indications