CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

hepatitis b vaccine (recombinant)

Trade name: Recombivax

Vaccineapproved

Approved

Jul 1, 1981

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected. — Wikipedia

Clinical trial activity

316 trials · 214 clinical orgs · 4 marketing orgs

Phase 1
37
Phase 2
148
Phase 3
115
Phase 4
95

Earliest trial started Nov 1, 1978 (NCT00000583)

Timeline

1970s

  1. Jan 1, 1978

    Earliest Phase 3 Sponsor(trial)

1980s

  1. Jul 1, 1981

    Earliest FDA Approval

  2. Jun 23, 1986

    Merck — First NDA Organization

  3. Jun 23, 1986

    Merck — NDA Organization

  4. Aug 28, 1989

    GlaxoSmithKline — NDA Secondary Org

1990s

  1. Jan 1, 1992

    GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1992

    GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)

2010s

  1. Nov 9, 2017

    Dynavax Technologies Corporation — NDA Secondary Org

2020s

  1. Nov 30, 2021

    VBI Vaccines Inc. — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 1, 1981

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • abx203
  • adjuvanted hepatitis b vaccine
  • engerix-b
  • euvax b
  • euvax b vaccine
  • fendrix
  • fendrix vaccine
  • genhevac b
  • genhevac b
  • genhevac-b
  • genhevac b pasteur
  • genhevac btm
  • hbsag
  • hbsag
  • hbvaxpro
  • hb vax pro
  • hbv surface antigen
  • hbv vaccin
  • hbv vaccine
  • henogen hb vaccine
  • hepatitis b antigen
  • hepatitis b antigen peptide
  • hepatitis b, recombinant surface antigen
  • hepatitis b surface antigen
  • hepatitis b surface antigen
  • hepatitis b surface antigen
  • hepatitis-b surface antigen
  • hepatitis b surface antigen (rdna)
  • hepatitis b surface antigen (recombinant)
  • hepatitis b surface antigens
  • hepatitis b surface antigen vaccine
  • hepatitis b vaccine
  • hepatitis b vaccine
  • hepatitis b vaccine
  • hepatitis b vaccine, inactivated
  • hepatitis b vaccine (recombinant)
  • hepatitis b vaccine (recombinant)
  • hepatitis b virus hbsag surface protein antigen
  • hepatitis b virus vaccine
  • hepavaxgene
  • hep b vaccine
  • heplisav
  • heptatis b surface antigen
  • heptavax
  • hepta-vax-b
  • hep-v vax
  • nasvac
  • recombinant hbv vaccine
  • recombinant hepatitis b vaccine
  • recombivax
  • recombivax
  • recombivax hb
  • sci-b-vac
  • twinrix

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06786429Phase 4Jan 31, 2026Eunice Dube, National Cancer Institute (NCI), National University of Science and Technology, Zimbabwe
NCT07077356Phase 1Aug 1, 2025Sichuan University
NCT06888479Phase 3Jun 1, 2025China Academy of Chinese Medical Sciences
NCT07069569Phase 2May 30, 2025Capital Medical University, Government of China
NCT06668727Phase 1Aug 26, 2024Aarhus University, Humboldt University
NCT06397768Phase 3May 13, 2024Sanofi-Aventis
NCT05967650N/ASep 1, 2023Assiut University
NCT05705427Phase 4Aug 17, 2023Abbott, Doris Duke Charitable Foundation, University of North Carolina at Chapel Hill, Yeshiva University
NCT05856890Phase 1Aug 7, 2023New York University, Rockefeller University
NCT05902624Early Phase 1 (Phase 1)Jun 10, 2023Assiut University
NCT05738447Phase 1Feb 15, 2023Sichuan University
NCT05272735Phase 4Dec 31, 2022Cornell University, Rockefeller University
NCT05482295Phase 3Oct 31, 2022PT Bio Farma, RS Prof. Dr. I.G.N.G Ngoerah
NCT05482282Phase 3Oct 31, 2022Government of Indonesia, PT Bio Farma
NCT05380388Phase 2Sep 20, 2022Mahidol University, University of Oxford
NCT05170399Phase 4Sep 14, 2022National Heart, Lung, and Blood Institute (NHLBI)
NCT04843852Phase 1Dec 31, 2021University of Maryland
NCT04674462Phase 4Dec 31, 2021National Institute of Allergy and Infectious Diseases (NIAID), New York University
NCT05099757Phase 4Nov 8, 2021Shanxi Medical University
NCT04970836N/AAug 1, 2021Academia Sinica, Taiwan, Government of Taiwan, National Taiwan University
Showing 20 of 316 trials
Page 1 / 16

Organizations

Research & Development (214)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GlaxoSmithKlineFor profit979051992
Government of ChinaGovernment15852006
MerckFor profit131231983
Sanofi-AventisFor profit13722007
Dynavax Technologies CorporationFor profit121042006
Centers for Disease Control and Prevention, ChinaGovernment10122011
National Institute of Allergy and Infectious Diseases (NIAID)Government10851999
Shanxi Medical UniversityAcademic/Hospital8812014
Baylor UniversityAcademic/Hospital7632010
PT Bio FarmaFor profit7732011
SanofiFor profit7722005
University of North Carolina at Chapel HillAcademic/Hospital7622004
Chiangmai UniversityAcademic/Hospital5522011
HenogenFor profit5512006
National Institute on Drug Abuse (NIDA)Government5132003
National Taiwan UniversityAcademic/Hospital5522005
NovartisFor profit5522004
University of LondonAcademic/Hospital5322007
VBI Vaccines Inc.For profit5522006
National Cancer Institute (NCI)Government4131998
214 organizations
Page 1 / 11

Marketing (4)

OrganizationOrg typeRelationshipDate
Dynavax Technologies CorporationFor profitNDA2Nov 9, 2017
GlaxoSmithKlineFor profitNDA2Aug 28, 1989
MerckFor profitNDAJun 23, 1986
VBI Vaccines Inc.For profitNDA2Nov 30, 2021