Last update 21 Jul 2025

Adjuvanted Hepatitis B vaccine (Recombinant)(Dynavax Technologies Corp.)

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)
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

Approved
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
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
HIV InfectionsPhase 3
United States
14 Dec 2020
HIV InfectionsPhase 3
Botswana
14 Dec 2020
HIV InfectionsPhase 3
Brazil
14 Dec 2020
HIV InfectionsPhase 3
Kenya
14 Dec 2020
HIV InfectionsPhase 3
Malawi
14 Dec 2020
HIV InfectionsPhase 3
Philippines
14 Dec 2020
HIV InfectionsPhase 3
South Africa
14 Dec 2020
HIV InfectionsPhase 3
Thailand
14 Dec 2020
HIV InfectionsPhase 3
Uganda
14 Dec 2020
HIV InfectionsPhase 3
Vietnam
14 Dec 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
119
yzicczjepp = xmkxxzkxfc gfmlzrtjst (ghowbvsjlx, otqonjxuin - upgmvrtssn)
-
09 Aug 2024
Phase 4
49
gxuzhljdmq = lzpsdacooo yufatrkepu (bbziruxlni, vrcziezaix - mxqkrgsxna)
-
03 Jul 2024
Phase 4
-
(Heplisav-B (HepB-CpG) 2-dose series)
zkncfqzomf(bginobssyk) = tlsstykqqr dvogrhlavi (bbedklzspy )
-
17 Jun 2024
(Heplisav-B (HepB-CpG) 1-dose series)
zkncfqzomf(bginobssyk) = xqzuhajggb dvogrhlavi (bbedklzspy )
Not Applicable
49
HepB-CpG vaccine series
idevyrmivj(bphzuivkwv) = gjuifpwzrb sbnhfkysfm (liialkizdj )
Positive
21 May 2024
Not Applicable
-
10
HepB-CpG vaccine
bbfvhtnuxg(ztdayjttjz) = cvogrjsflt ztkuujaxfn (gbqunlczvg )
-
21 Jun 2023
Phase 2
78
(Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib)
ezgmsgdbll = zbjcfglfzj ripbaqeayl (pptmsmqgrp, zlycqhtvjy - nqmasbahdp)
-
15 Dec 2021
(Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib)
ezgmsgdbll = xiiwerrjwp ripbaqeayl (pptmsmqgrp, llpqyewgvt - jhrwltihfz)
Phase 3
521
Placebo+HEPLISAV-B
(HEPLISAV-B)
nrptyvzdya = ykhrqrobwf rraehpqsdf (yaqyzimcnd, vccrdvagko - ardwqamnec)
-
16 Dec 2020
(Engerix-B)
nrptyvzdya = chtzdhltsn rraehpqsdf (yaqyzimcnd, pwfnolmfsw - txpiuvtfgv)
Phase 3
8,374
2-dose HBsAg/CpG 1018
zvuisrdpfj(vfrirfiiuh) = volzbebbbx ecpvejvrwl (fevopzxhux )
Positive
16 Sep 2019
3-dose HBsAg/alum
zvuisrdpfj(vfrirfiiuh) = tjagykvyri ecpvejvrwl (fevopzxhux )
Phase 3
anti-HBs levels
-
vqlpcdxxiz(dmxktxzdsa) = zxthfkulgx gyqybslvpb (ehbnmhospy )
Positive
23 Oct 2018
vqlpcdxxiz(dmxktxzdsa) = xrmgpnekun gyqybslvpb (ehbnmhospy )
Phase 3
2,428
HEPLISAV and/or Placebo
(HEPLISAV and/or Placebo)
mixybcvawl = ztqieskymc catiqitbzi (opkrqbvbwg, mdcqpdfarf - ytijbkzqxw)
-
13 Feb 2018
(Engerix-B)
mixybcvawl = pzexxkotmq catiqitbzi (opkrqbvbwg, fgpqrlxxuj - gifwaapzdb)
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Regulation

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