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Drugs / Engerix-B
last change May 2026 re-read 9 days ago

Engerix-B

also known as Engerix · Hepatitis B Vaccine · Engerix TM · Engerix-BTM · EngerixTM-B · HBsAg-Eng · HBV vaccine

Vaccine

Developed for
hepatitis B virus infection · chronic hepatitis B virus infection
Investigated by
GlaxoSmithKline · Chang Gung Memorial Hospital · National Institute on Drug Abuse (NIDA) · National Taiwan University Hospital · VBI Vaccines Inc. · Academia Sinica, Taiwan
+27 more · Academic Medical Center - University of Amsterdam · Centre de Recheche du Centre Hospitalier Université Laval · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Centre for Infectious Disease Research in Zambia · French National Agency for Research on AIDS and Viral Hepatitis · Guangxi Center for Disease Control and Prevention · Hui Zhuang · Immuno-US · Institut National en Santé Publique du Québec · Laval University · Mahidol University · Ministry of Science and Technology, Taiwan · National Institute for Public Health and the Environment (RIVM) · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Mental Health (NIMH) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Sanofi Pasteur, a Sanofi Company · SmithKlinBeecham Biologicals · Soroka University Medical Center · St. Joseph's Health Care London · Taipei Veterans General Hospital, Taiwan · The University of Hong Kong · University of California, San Francisco · University of North Carolina, Chapel Hill · University of Oxford · University of Surrey · Wu Jiang

Trials 42

today NCT04970836 · not/applicable NCT05200338 · not/applicable NCT04519710 · not/applicable NCT04072211 · Ph 4 NCT04083157 · Ph 2/3 NCT03408730 · Ph 3 NCT03393754 · Ph 3 NCT03854630 · Ph 4 NCT03405597 · Ph 3 NCT02901951 · Ph 4 NCT02505009 · Ph 4 NCT02032160 · not/applicable NCT01817725 · Ph 1 NCT06515938 · not/applicable NCT01627340 · Ph 4 NCT01531075 · not/applicable NCT01345240 · Ph 3 NCT01082861 · Ph 4 NCT01138098 · Ph 4 NCT01037114 · Ph 4 NCT01000324 · Ph 4 NCT01861613 · Ph 4 NCT00774995 · Ph 4 NCT00693186 · Ph 3 NCT00657657 · Ph 4 NCT00603252 · Ph 4 NCT00524576 · Ph 4 NCT00534638 · Ph 4 NCT00456625 · Ph 4 NCT00120796 · Ph 3 NCT00142753 · Ph 4 NCT00197158 · Ph 4 NCT00186836 · Ph 4 NCT00244374 · not/applicable NCT00343915 · Ph 3 NCT00240500 · Ph 4 NCT00383591 · Ph 3 NCT00383383 · Ph 3 NCT00000633 · Ph 1 NCT00697775 · Ph 2 NCT00169858 · Ph 4 NCT00697229 · Ph 2
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT01817725 Mar 2013 → Feb 2016 chronic hepatitis B virus infection Chang Gung Memorial Hospital Completed No outcome recorded
Phase 1 NCT00000633 ? → Oct 1998 HIV infectious disease National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00697775 Mar 1998 → May 1999 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00697229 Sep 1992 → May 1996 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 2/31 trial · 1 met primary
Phase 2/3 NCT04083157 Aug 2019 → Dec 2020 hepatitis B virus infection, inflammatory bowel disease The University of Hong Kong Completed Met primary
Phase 39 trials · 2 met primary
Phase 3 NCT03408730 Dec 2017 → Oct 2019 hepatitis B virus infection VBI Vaccines Inc. Completed Met primary
Phase 3 NCT03393754 Dec 2017 → Apr 2019 hepatitis B virus infection VBI Vaccines Inc. Completed Met primary
Phase 3 NCT03405597 Mar 2017 → Feb 2018 chronic hepatitis B virus infection Mahidol University Unknown No outcome recorded
Phase 3 NCT01345240 Nov 2011 → Jan 2013 malaria GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00693186 Oct 2008 → Dec 2009 hepatitis B virus infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT00120796 Aug 2005 → Jul 2008 chronic hepatitis B virus infection French National Agency for Research on AIDS and Viral Hepatitis Terminated No outcome recorded
Phase 3 NCT00343915 Apr 2004 → Jan 2008 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00383591 Mar 2002 → Jan 2004 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00383383 Dec 1999 → ? hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 421 trials · 1 met primary
Phase 4 NCT04072211 Nov 2019 → Aug 2020 hepatitis B virus infection, nosocomial infection Centre for Infectious Disease Research in Zambia Completed No outcome recorded
Phase 4 NCT03854630 Sep 2017 → Jun 2023 HIV infectious disease, hepatitis B virus infection National Taiwan University Hospital Unknown No outcome recorded
Phase 4 NCT02901951 Oct 2016 → May 2017 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT02505009 May 2015 → Dec 2018 chronic hepatitis B virus infection Chang Gung Memorial Hospital Completed No outcome recorded
Phase 4 NCT01627340 Jul 2012 → Dec 2013 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01082861 Sep 2010 → Apr 2011 human papilloma virus infection National Institute for Public Health and the Environment (RIVM) Terminated No outcome recorded Stop: Business
Phase 4 NCT01138098 Jun → Nov 2010 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01037114 Jan 2010 → Feb 2014 hepatitis A virus infection, hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01000324 Nov 2009 → Jul 2014 hepatitis A virus infection, hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01861613 Sep 2009 → Nov 2011 hepatitis B virus infection Hui Zhuang Completed No outcome recorded
Phase not applicable7 trials
— NCT04970836 Aug 2021 → Dec 2027 expected hepatitis B virus infection National Taiwan University Hospital Recruiting No outcome recorded
— NCT05200338 Jun 2021 → Jan 2024 sickle cell disease Academic Medical Center - University of Amsterdam Unknown No outcome recorded
— NCT04519710 Sep 2020 → Sep 2021 hepatitis B virus infection Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida Completed No outcome recorded
— NCT02032160 May 2014 → Feb 2016 hepatitis B virus infection University of Surrey Completed No outcome recorded
— NCT06515938 Jan 2013 → Jun 2014 vaccinia Wu Jiang Completed No outcome recorded
— NCT01531075 Apr 2012 → Aug 2015 inflammatory bowel disease Soroka University Medical Center Completed No outcome recorded
— NCT00244374 Aug 2004 → Jun 2008 hepatitis A virus infection, hepatitis B virus infection, hepatitis C virus infection, substance abuse University of California, San Francisco Completed No outcome recorded
Comparator or background therapy63 trials
Phase 1 NCT02942277 Comparator Oct 2016 → Jul 2020 malaria National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 1 NCT00814489 Comparator Jan → May 2009 haemophilus infectious disease, pneumococcal infection GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT00354861 Comparator May → Nov 2005 — Immutep S.A.S. Completed No outcome recorded
Phase 1 NCT00699231 Comparator Feb → Dec 1992 hepatitis B virus infection GlaxoSmithKline Completed No outcome recorded
Phase 1/2 NCT03910972 Comparator Oct 2019 → Nov 2024 Schistosoma mansoni infectious disease Baylor College of Medicine Completed No outcome recorded

News releases announcing trial results or a regulatory action · 9

DateIssuerRelease
2023-06-25 Brii Biosciences Limited Results Brii Bio Announces New Data from Partners Underscoring Potential for HBV Functional Cure at EASL™ Congress 2023 briibio.com ↗
2022-06-28 VBI Vaccines Inc. Results VBI Vaccines Announces New Long-Term Follow-Up Clinical Data for its 3-Antigen Adult Hepatitis B Vaccine Presented at EASL 2022 vbivaccines.com ↗
In the follow-up analysis, participants in PROTECT who received VBI’s 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B.
2021-10-13 VBI Vaccines Inc. Results VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, CONSTANT, of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Journal of the American Medical Association Network Open vbivaccines.com ↗
VBI’s vaccine candidate demonstrated robust and consistent immune responses across all three lots after two and three doses, with higher seroprotection rates and antibody geometric mean concentration (GMC) compared to Engerix-B®
2021-05-12 VBI Vaccines Inc. Results VBI Vaccines Announces Publication of Results from Pivotal Phase 3 Study, PROTECT, of VBI’s Prophylactic 3-Antigen Hepatitis B Vaccine Candidate in The Lancet Infectious Diseases vbivaccines.com ↗
Regardless of age, BMI, or diabetic status, participants who received VBI’s vaccine candidate achieved higher seroprotection rates and 5-8x higher antibody geometric mean concentration (GMC) compared to Engerix-B®
2020-11-13 VBI Vaccines Inc. Results VBI Vaccines Presents Phase 3 Sci-B-Vac® Data at The Liver Meeting® 2020 vbivaccines.com ↗
A 3-antigen hepatitis B vaccine (3AV) provides consistently higher seroprotection rates (SPR) and anti-HBs titers compared to single-antigen vaccine in adults with comorbidities known to be associated with poor response to vaccinations
2020-01-09 VBI Vaccines Inc. Results VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints vbivaccines.com ↗
Sci-B-Vac® achieved seroprotection rates of 99.3% and 90.4% after three and two doses, respectively, compared with 94.8% and 51.6% with Engerix-B®, respectively
2019-10-22 VBI Vaccines Inc. Results VBI Vaccines Announces Late-Breaker Poster Presentation at The Liver Meeting® 2019 vbivaccines.com ↗
The successfully-met co-primary endpoints of (i) non-inferiority of seroprotection rate in all subjects age 18+ who received Sci-B-Vac compared to Engerix-B, and (ii) superiority of seroprotection rate in subjects age 45+ who received Sci-B-Vac compared to Engerix-B;
2019-10-02 VBI Vaccines Inc. Results VBI Vaccines Announces Late-Breaker Oral Presentation at IDWeek 2019™ vbivaccines.com ↗
Notably, Dr. Langley will highlight the two successfully-met co-primary endpoints and detailed seroprotection data in key patient subgroups, including by age group, gender, diabetic status, body mass index, and smoking status.
2019-06-17 VBI Vaccines Inc. Results VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac® vbivaccines.com ↗
The SPR in all subjects age ≥ 18 years who received Sci-B-Vac® was 91.4% compared with 76.5% for subjects who received Engerix-B®

All press releases naming this drug 28 releases

DateIssuerRelease

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 114 sources stand behind the page.

FieldValueCited text
Known as Engerix B “METHODS: HIV-infected youth, aged 12 to younger than 25 years, were randomly assigned to one of three treatment arms: Arm 1: Engerix B, 20 μg HBsAg; Arm 2: Engerix B...” PMID 21350366 ↗ Apr 2011
119

“The primary objective of the study is to verify that the manufacturing equivalence of Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose...” NCT03408730 ↗

“Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered...” NCT00197158 ↗

“Evaluation of the specific anti-HBV vaccine response, measured by the level of anti-HBs antibodies greater than 10 IU / l at M2, M6 and M13 in patients having received a...” NCT04519710 ↗

“Eligible patients will be randomized to receive either intradermal vaccination with Engerix B with topical imiquimod or intramuscular vaccination with Engerix-B with topical...” NCT04083157 ↗

“Participants in the control arm will receive 20 mcg intramuscular Engerix-B at two separate sites (10 mcg/ 0.5 ml) with topical placebo aqueous cream pretreatment 5 minutes...” NCT04083157 ↗

“Children received a single intramuscular challenge dose of either hepatitis B vaccine, HBVaxPro (Hexavac, n=34; Infanrix-Hexa, n=28) or Engerix-B (Hexavac, n=167; Infanrix-Hexa, n=181).” PMID 22789511 ↗ Jul 2012

“This is an open label clinical study designed to evaluate the safety and immunogenicity of Sci-B-Vac Hepatitis B Vaccine compared to Engerix-B Hepatitis B Vaccine in dialysis patients.” NCT01933412 ↗

“who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule” NCT00289731 ↗

“received a 0.5-mL intramuscular dose of 5-μg mpHBV, Recombivax-HB (5 μg), 10-μg mpHBV, or Engerix-B (10 μg) at day 1, month 2, and month 4 (2, 4, 6 months of age).” PMID 21552183 ↗ Jul 2011

“ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration.” NCT02942277 ↗

Show 109 more sources
Known as Engerix “Eligible patients will be randomized to receive a 3-dose vaccination series with Engerix or Sci-B-Vac vaccines.” NCT01159457 ↗
1

“Engerix™ (Hepatitis B [HBV] vaccine)” NCT00652938 ↗
Known as Engerix TM “GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)” NCT00861380 ↗
Known as Engerix-BTM “We estimated the cost-effectiveness of this 3-antigen vaccine (PreHevbrio™) relative to the single-antigen vaccine, Engerix-BTM, to prevent hepatitis B virus (HBV) infection...” PMID 37147201 ↗ May 2023
Known as EngerixTM-B “Biological: EngerixTM-B” NCT00774995 ↗
Known as HBsAg-Eng “Phase 3 observer-blinded, randomized (2:1 HBsAg-1018 [HEPLISAV-B™]:HBsAg-Eng [Engerix-B®]), active-controlled trial” PMID 29289383 ↗ Dec 2017
Known as HBV vaccine “Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule” NCT00861380 ↗
Known as Hepatitis B Vaccine “hepatitis B vaccine (EngerixB)” NCT00739128 ↗
1

“ENGERIX-B Hepatitis B Vaccine” NCT03910972 ↗
Modality Vaccine “hepatitis B vaccine (Engerix-B)” NCT00000633 ↗
Route Intramuscular “administered in the deltoid muscle” NCT00106964 ↗