drugset / Trial / NCT02003703
Comparative Efficacy of an Intensified Re-vaccination Scheme for Hepatitis B Virus Infection Among Patients Infected With HIV .
Phase 3
Completed
107 enrolled
Universidad de Valparaiso
Aclin Laboratory · collabGlaxoSmithKline · collabRoche Pharma AG · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Hepatitis B Virus Vaccine | Vaccine | 20 ug | — |
| Subject | Recombinant Hepatitis B Virus Vaccine | Vaccine | 40 ug | — |