Immunogenicity and safety of an adjuvant hepatitis B vaccine (fendrix) compared to Engerix in non-responding HIV-infected patients

• Conditions: We want to study the efficacy of Fendrix, a new adjuvant hepatitis B vaccin, in HIV infected patients, who failed to respond on intial standard and subsequent booster Hepatitis b vaccinations. We want to compare the efficacy of Fendrix to the efficacy of a double dose of the standard hepatitis b vaccinations, Engerix; MedDRA version: 12.1Level: LLTClassification code 10002725Term: Anti-HIV positive

• Registration Number: EUCTR2010-023946-58-NL
• Lead Sponsor: ErasmusMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible patients must be on HAART, with HIV-RNA < 200 copies/ml and CD4+-cell counts > 200/ml and negative HBsAg, anti-HBc and anti-HBs titers.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
-co-infection with hepatitis C
-pregnancy
-radiation therapy
-cytotoxic agents
-any immunemodulator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified