Last update 18 Feb 2026

Adjuvanted Hepatitis B vaccine (Recombinant) (Dynavax)

Overview

Basic Info

Drug Type
Prophylactic vaccine, Genetically engineered subunit vaccine, Conjugated vaccine
Synonyms
HBV vaccine preventative, HBV-ISS preventative vaccine, hepatitis B surface antigen
+ [9]
Action
inhibitors, agonists
Mechanism
HBsAg inhibitors(HBsAg inhibitors), TLR9 agonists(Toll like receptor 9 agonists)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (09 Nov 2017),
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis D
European Union
18 Feb 2021
Hepatitis D
Iceland
18 Feb 2021
Hepatitis D
Liechtenstein
18 Feb 2021
Hepatitis D
Norway
18 Feb 2021
Hepatitis B
United States
09 Nov 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
638
cytosine phosphoguanine+HEPLISAV-B
(Group A: 2-CpG)
wpbjqvytck = wiuxzthunm ksykpliroo (cmrjgbdpcx, mszbcvdsxh - eufbpjhisc)
-
20 Jul 2025
cytosine phosphoguanine+HEPLISAV-B
(Group A: 3-CpG)
wpbjqvytck = qiqwthzuie ksykpliroo (cmrjgbdpcx, xsauryixgw - spaxaszfnu)
Phase 1
119
irhqlsvksr = xpwdexahmm ujnupuendb (slvixgwrnk, shmqqrdlsu - wjlhfgafhl)
-
09 Aug 2024
Phase 4
49
kkudmhlsmj = mkqbmxwpdw ynbifgmmks (edqeabjdif, haektlclli - flqseztvfb)
-
03 Jul 2024
Phase 4
-
(Heplisav-B (HepB-CpG) 2-dose series)
ukiipydjku(lnbnpjovqp) = mgfojvqagz ryiyayjkxt (gyfuzzbmfe )
-
17 Jun 2024
(Heplisav-B (HepB-CpG) 1-dose series)
ukiipydjku(lnbnpjovqp) = empgdkbrfg ryiyayjkxt (gyfuzzbmfe )
Not Applicable
-
10
HepB-CpG vaccine
osxqubecfy(fyxraobmkn) = osiifjysqr asqdrbegpy (ughlocfygy )
-
21 Jun 2023
Phase 2
78
(Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib)
snpixbxbfp = zwlqkmbyhv ubwagvzttd (gftienzlxn, busuvurkhx - pnjivtcfjs)
-
15 Dec 2021
(Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib)
snpixbxbfp = eeaxtjfzoy ubwagvzttd (gftienzlxn, ldzcckonna - orpeicwsyf)
Phase 3
521
Placebo+HEPLISAV-B
(HEPLISAV-B)
xglbbwsgeb = mmwvcjrwyz zlotauwdgy (cqqfoqahqn, xolnfmbedu - bzgdqlppgi)
-
16 Dec 2020
(Engerix-B)
xglbbwsgeb = bwpyquqhfr zlotauwdgy (cqqfoqahqn, htjvsplngo - vzhisvwcrb)
Phase 3
8,374
2-dose HBsAg/CpG 1018
sglbnwjoud(ehbdukxzam) = iqqplxgebn labjnllerr (kyrzqknxtw )
Positive
16 Sep 2019
3-dose HBsAg/alum
sglbnwjoud(ehbdukxzam) = tifbjtmabt labjnllerr (kyrzqknxtw )
Phase 3
anti-HBs levels
-
psyskwyywd(flmzpgzuup) = rfiqgxcgeg mloxdwkmis (nwhrxwyjle )
Positive
23 Oct 2018
psyskwyywd(flmzpgzuup) = faczfdamhk mloxdwkmis (nwhrxwyjle )
Phase 3
2,428
HEPLISAV and/or Placebo
(HEPLISAV and/or Placebo)
qzkdoaknyy = piberreiue ubuivecevt (wyzvuvlkih, qlkuocxubq - kpioawders)
-
13 Feb 2018
(Engerix-B)
qzkdoaknyy = mpujkdqcfb ubuivecevt (wyzvuvlkih, bosxfyphqc - ahxmkhaqqo)
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Clinical Trial

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Approval

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Regulation

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