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Last Updated: July 27, 2021

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CLINICAL TRIALS PROFILE FOR ENGERIX-B

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All Clinical Trials for ENGERIX-B

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00120796 ↗ Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2) Terminated GlaxoSmithKline Phase 3 2005-08-01 Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.
NCT00120796 ↗ Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2) Terminated French National Agency for Research on AIDS and Viral Hepatitis Phase 3 2005-08-01 Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.
NCT00133445 ↗ Pentavalent DTaP-Hep B-IPV Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2005-12-01 The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.
NCT02434848 ↗ A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses Recruiting Sheffield Teaching Hospitals NHS Foundation Trust Phase 2/Phase 3 2015-08-01 Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ENGERIX-B

Condition Name

Condition Name for ENGERIX-B
Intervention Trials
Hepatitis B 3
Communicable Diseases 1
Pertussis 1
Chronic Hepatitis B 1
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Condition MeSH

Condition MeSH for ENGERIX-B
Intervention Trials
Hepatitis B 4
Hepatitis B, Chronic 2
Hepatitis A 2
Hepatitis 2
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Clinical Trial Locations for ENGERIX-B

Trials by Country

Trials by Country for ENGERIX-B
Location Trials
United States 1
Senegal 1
Taiwan 1
United Kingdom 1
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Trials by US State

Trials by US State for ENGERIX-B
Location Trials
California 1
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Clinical Trial Progress for ENGERIX-B

Clinical Trial Phase

Clinical Trial Phase for ENGERIX-B
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for ENGERIX-B
Clinical Trial Phase Trials
Enrolling by invitation 1
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for ENGERIX-B

Sponsor Name

Sponsor Name for ENGERIX-B
Sponsor Trials
Sheffield Teaching Hospitals NHS Foundation Trust 1
National Institute of Allergy and Infectious Diseases (NIAID) 1
French National Agency for Research on AIDS and Viral Hepatitis 1
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Sponsor Type

Sponsor Type for ENGERIX-B
Sponsor Trials
Other 3
Industry 1
NIH 1
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