NCT02732054

Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts

Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.

Detailed description

HIV-infected adults with CD4+ cell counts \< 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group). This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]	Different HBV vaccine regimen in each group

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-04-08
• Last updated: 2017-04-19

Locations

1 site across 1 country: Thailand