NCT02713620

Hepatitis B Vaccination in HIV-infected Adults

Comparison of Immunogenicity of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-infected Adults: a Result From Randomized Controlled Trial at 3 Years After Vaccination

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a follow up study from the published article entitled "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" by Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. that was published in PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013. ClinicalTrials.gov; NCT1289106. This study aimed to evaluate the efficacy of the HBV vaccination regimens using either four standard doses or four double doses compared with the current standard regimen of three doses in HIV-infected adults in northern Thailand. In addition, the investigators evaluated the efficacy of the HBV vaccination with the current standard regimen of three doses between healthy adults and HIV-infected patients.

Detailed description

From February 4, 2011 to May 4, 2012, 132 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 three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (four double doses group, n=44). There was another group of healthy individuals received standard dose of 20 μg IM at months 0, 1, and 6 recruited during the same time and under the same protocol. In brief, at months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (P=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (P=0.434 and 0.062), respectively. This current study aimed to evaluate the efficacy of the different HBV vaccination regimens at 36 months after vaccination. In addition to compare the group using four standard doses or four double doses with the current standard regimen of three doses in HIV-infected adults in northern Thailand, the investigators also compare the efficacy of the current standard regimen of 3 doses between HIV-infected and healthy individuals.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)	Different HBV vaccine regimen in each group

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2016-03-21
• Last updated: 2017-04-19

Locations

1 site across 1 country: Thailand