drugset / Trial / NCT01289106
Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects
RandomizedParallel-groupOpen-labelPrevention
Summary
The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.
Timeline
- Start
- 2011-01
- Primary completion
- 2011-10
- Completion
- 2012-04
Publications
- Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.
- Chawansuntati K, Chaiklang K, Chaiwarith R, Praparattanapan J, Supparatpinyo K, Wipasa J. Hepatitis B Vaccination Induced TNF-alpha- and IL-2-Producing T Cell Responses in HIV- Healthy Individuals Higher than in HIV+ Individuals Who Received the Same Vaccination Regimen. J Immunol Res. 2018 Feb 27;2018:8350862. doi: 10.1155/2018/8350862. eCollection 2018.
- Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HepavaxGene | Vaccine | 20 ug | Intramuscular |
| Subject | HepavaxGene | Vaccine | 40 ug | Intramuscular |