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: 12.1 Level: LLT Classification code 10002725 Term: Anti-HIV positive
Conditions
Interventions
Trade Name: Fendrix
Pharmaceutical Form: Injection*
Trade Name: Fendrix
Pharmaceutical Form: Injection*
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients must be on HAART, with HIV-RNA 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: Exclusion criteria - co-infection with hepatitis C - pregnancy - radiation therapy - cytotoxic agents - any immunemodulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to study the effectiveness of this new vaccine, Fendrix®, in comparison to the regular vaccine Engerix®, in HIV-infected non-reponders to HBV primary vaccination schedule and non-responders to a subsequent double dose revaccination scheme. The primary endpoint is protective levels of anti-HBs (>10 IU) at week 28 ;Secondary Objective: The pattarn of anti-HBs respnise;Primary end point(s): Primary endpoint Protective levels of anti-HBs (? 10 IU) at week 28 | — |
Countries
Netherlands
Outcome results
None listed