recombinant hepatitis B vaccine

also known as HB vaccine · HepB · recombinant HBV vaccine

Developed for: hepatitis B virus infection · Hepadnaviridae infectious disease
Investigated by: Centers for Disease Control and Prevention, China · Shanxi Medical University · Jiangsu Province Centers for Disease Control and Prevention · Shenzhen Kangtai Biological Products Co., LTD · Chiang Mai University · Guangdong Center for Disease Prevention and Control
+4 more
· Guangdong Provincial Institute of Biological Products And Materia Medica · Institute of Medical Biology, Chinese Academy of Medical Sciences · PT Bio Farma · Sinovac Biotech Co., Ltd

Trials 9

today NCT03919578 · Ph 2/3 NCT03962803 · Ph 4 NCT03962816 · Ph 4 NCT03962881 · Ph 4 NCT06209398 · Ph 4 NCT03274102 · Ph 4 NCT02764671 · Ph 4 NCT02732054 · Ph 4 NCT01203319 · Ph 2/3

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2/32 trials
Phase 2/3	NCT03919578	Sep 2019 → Jan 2020	—	PT Bio Farma	Completed	No outcome recorded
Phase 2/3	NCT01203319	Nov 2006 → Dec 2010	hepatitis B virus infection	Jiangsu Province Centers for Disease Control and Prevention	Completed	No outcome recorded
Phase 47 trials · 2 met primary
Phase 4	NCT03962803	Jun 2019 → Feb 2020	hepatitis B virus infection	Shanxi Medical University	Unknown	Met primary
Phase 4	NCT03962816	May 2019 → Feb 2020	hepatitis B virus infection	Shanxi Medical University	Unknown	No outcome recorded
Phase 4	NCT03962881	May 2019 → Feb 2020	hepatitis B virus infection	Shanxi Medical University	Unknown	No outcome recorded
Phase 4	NCT06209398	May 2018 → Dec 2024	hand, foot and mouth disease	Jiangsu Province Centers for Disease Control and Prevention	Unknown	No outcome recorded
Phase 4	NCT03274102	Apr → Nov 2017	hand, foot and mouth disease	Sinovac Biotech Co., Ltd	Completed	Met primary
Phase 4	NCT02764671	May 2015 → Sep 2020	hepatitis B virus infection	Shenzhen Kangtai Biological Products Co., LTD	Unknown	No outcome recorded
Phase 4	NCT02732054	Mar 2015 → Feb 2016	hepatitis B virus infection	Chiang Mai University	Completed	No outcome recorded
Comparator or background therapy4 trials
Phase 1	NCT04075201 Comparator	Jul 2019 → May 2021	hepatitis B virus infection	Sinovac Biotech Co., Ltd	Completed	No outcome recorded
Phase 3	NCT01453348 Comparator	Oct 2011 → Jan 2012	hepatitis A virus infection, hepatitis B virus infection, meningococcal meningitis	Novartis Vaccines	Completed	No outcome recorded
Phase 3	NCT01183611 Comparator	Apr 2007 → Jun 2010	Hepadnaviridae infectious disease	Jiangsu Province Centers for Disease Control and Prevention	Completed	No outcome recorded
—	NCT01412567 Comparator	Oct 2005 → Jun 2010	chronic hepatitis B virus infection	Govind Ballabh Pant Hospital	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 1

Date	Issuer	Release
2019-04-08	Sinovac Biotech Co., Ltd	Results 北京科兴EV71疫苗联合免疫研究成果受到国际广泛关注 sinovac.com ↗ 结果表明联合免疫不会影响疫苗的免疫原性和安全性。

All press releases naming this drug 1 release

Date	Issuer	Release
2019-04-08	Sinovac Biotech Co., Ltd	北京科兴EV71疫苗联合免疫研究成果受到国际广泛关注 sinovac.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

Field	Value	Cited text
Known as	recombinant hepatitis B vaccine	“This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B...” PMID 30891604 ↗ Jul 2019 12 “Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh” NCT01412567 ↗ “This is a phase Ⅰ clinical trial of recombinant hepatitis B vaccine (Hansenula polymorpha,10μg)” NCT04075201 ↗ NCT01203319 ↗ NCT03962881 ↗ NCT03962816 ↗ NCT03962803 ↗ NCT01183611 ↗ NCT03919578 ↗ NCT06209398 ↗ NCT01453348 ↗ Show 2 more sources
Known as	HB vaccine	“Alternative schedules are needed to provide greater immunogenicity in adults who fail to respond to the standard hepatitis B (HB) vaccine regimen.” PMID 24681228 ↗ Mar 2014
Known as	HepB	“This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B...” PMID 30891604 ↗ Jul 2019
Known as	recombinant HBV vaccine	“Immediately after delivery, babies were randomized to receive either HBIG or placebo in addition to recombinant HBV vaccine (at 0, 6, 10 and 14 weeks).” PMID 24168259 ↗ Apr 2013
Modality	Vaccine	“This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast).” NCT01183611 ↗
Route	Intramuscular	“by intramuscular injection in the anterolateral thigh” NCT01412567 ↗