drugset / Trial / NCT02003703

Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .

NCT02003703 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

Hepatitis B virus infection is a common occurrence among patients with HIV. Effective vaccines are available, but there's some uncertainty regarding specific dosages, specially among those who have not responded to an initial vaccination. The purpose of this study is to determine the effectiveness of a simplified immunization schedule compared to a high-dose one.

Timeline

Start
2015-05
Primary completion
2018-06
Completion
2018-12

Outcome

Met primary endpoint

paper standard-dose group (51%; 95% CI, 37.1%-64.6%) (odds ratio, 2.48; 95% CI, 1.02-6.10; P = .03). PMID 34424307 ↗

paper use of a high-dose regimen for HBV revaccination for patients with HIV achieves a higher and longer-lasting serological response as compared with a standard-dose regimen. PMID 34424307 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Hepatitis B Virus Vaccine Vaccine 20 ug —
Subject Recombinant Hepatitis B Virus Vaccine Vaccine 40 ug —