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

Phase 2

Completed

• Conditions: efficacy and safety of 2 different hepatitis B vaccinations; 10047438

• Registration Number: NL-OMON36269
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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.

Exclusion Criteria

pregnancy, CD4 cell count < 200/ml, HCV co-infection, radiation therapy, cytotoxic agents, any immunemodulator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is anti-HBs titer at week 28</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pattern of anti-HBs response</p><br>