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Heplisav-B (Heplisav-B)

Other Names: Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpG

All Clinical Trials

HBV-10: Heplisav-B versus Engerix-B in Healthy Adults 18-55 Years of Age Industry
Official Title A Phase III Safety and Efficacy Study to Compare Immune Responses Following Injection With Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®
Purpose / DescriptionNote: 11-17 year olds eligible but only 13 of the 2428 randomized were age 11-17 years (most had previously received HBV vaccine as child as part of universal HBV vaccine program). 
Phase Phase III
ClinicalTrials.gov NCT00435812
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Halperin SA, Ward B, Cooper C, et al. Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age. Vaccine. 2012;30:2556-63.
    [PubMed Abstract]
HBV-16: Heplisav-B versus Engerix-B in Healthy Adults 40-70 Years of Age Industry
Official Title An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
Phase Phase III
ClinicalTrials.gov NCT01005407
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Heyward WL, Kyle M, Blumenau J, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013;31:5300-5.
    [PubMed Abstract]
HBV-17: Heplisav-B versus Engerix-B in CKD Industry
Official Title An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
Phase Phase III
ClinicalTrials.gov NCT00985426
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Janssen RS, Mangoo-Karim R, Pergola PE, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine. 2013;31:5306-13.
    [PubMed Abstract]
HBV-17 (Diabetes Mellitus Subgroup): Heplisav-B versus Engerix-B in CKD Industry
Official Title An Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
Phase Phase III
ClinicalTrials.gov NCT00985426
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Janssen JM, Heyward WL, Martin JT, Janssen RS. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus. Vaccine. 2015;33:833-7.
    [PubMed Abstract]
HBV-23: Heplisav-B versus Engerix-B in Subpopulations Aged 18-70 Industry
Official Title A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
Phase Phase III
ClinicalTrials.gov NCT02117934
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Jackson S, Lentino J, Kopp J, et al. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine. 2018;36:668-674.
    [PubMed Abstract]
HBV-23 (Diabetes Mellitus Subgroup) in Persons 60-70 Years of Age Industry
Official Title A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
Phase Phase III
ClinicalTrials.gov NCT02117934
Treatments
Heplisav-B

Heplisav-B

Tradename:Heplisav-BOther Names:Hepatitis B Vaccine (Recombinant) Adjuvanted, HepB-CpGClass:Vaccines (HBV)
Funding
IndustryDynavax Technologies Corporation
References
  • Hyer RN, Janssen RS. Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60-70 years. Vaccine. 2019;37:5854-61.
    [PubMed Abstract]

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