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

Background: HBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm3 although the efficacy is only 33.3% -65%. We conducted a randomized, controlled trial to evaluate the efficacy and safety of three regimens of HBV vaccination at Chiang Mai University Hospital, Thailan...

Full description

Saved in:
Bibliographic Details
Main Authors: Kanokporn Chaiklang, Jiraprapa Wipasa, Romanee Chaiwarith, Jutarat Praparattanapan, Khuanchai Supparatpinyo
Format: Journal
Published: 2018
Subjects:
Online Access:https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84893000793&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/52058
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Chiang Mai University
id th-cmuir.6653943832-52058
record_format dspace
spelling th-cmuir.6653943832-520582018-09-04T09:32:22Z 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 Kanokporn Chaiklang Jiraprapa Wipasa Romanee Chaiwarith Jutarat Praparattanapan Khuanchai Supparatpinyo Agricultural and Biological Sciences Biochemistry, Genetics and Molecular Biology Medicine Background: HBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm3 although the efficacy is only 33.3% -65%. We conducted a randomized, controlled trial to evaluate the efficacy and safety of three regimens of HBV vaccination at Chiang Mai University Hospital, Thailand. Methods: 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 ìg IM at months 0, 1, 2, and 6 (four double doses group, n=44). The primary outcomes were to compare the immunogenicity and safety between the four-doses groups with the Standard doses group. Results: 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. Factors associated with a high titer level (anti-HBs ≥100 mIU/mL) were vaccination schedule and younger age. The most common adverse event was pain at the injection site (42.4%); this was significantly more frequent in the four double doses group compared to the Standard doses group. No serious adverse events were observed. Conclusions: In Northern Thailand, the standard three-doses HBV vaccination in HIV-infected adults with CD4+ cell counts >200 cells/mm3 and undetectable plasma HIV-1 RNA is highly effective. Although regimens of four injections of either standard or double doses could not significantly increase the response rate, these regimens may induce higher levels of antibody to the virus. Trial registration information: ClinicalTrials.gov; NCT1289106 © 2013 Chaiklang et al. 2018-09-04T09:20:34Z 2018-09-04T09:20:34Z 2013-11-12 Journal 19326203 2-s2.0-84893000793 10.1371/journal.pone.0080409 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84893000793&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/52058
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Agricultural and Biological Sciences
Biochemistry, Genetics and Molecular Biology
Medicine
spellingShingle Agricultural and Biological Sciences
Biochemistry, Genetics and Molecular Biology
Medicine
Kanokporn Chaiklang
Jiraprapa Wipasa
Romanee Chaiwarith
Jutarat Praparattanapan
Khuanchai Supparatpinyo
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
description Background: HBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm3 although the efficacy is only 33.3% -65%. We conducted a randomized, controlled trial to evaluate the efficacy and safety of three regimens of HBV vaccination at Chiang Mai University Hospital, Thailand. Methods: 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 ìg IM at months 0, 1, 2, and 6 (four double doses group, n=44). The primary outcomes were to compare the immunogenicity and safety between the four-doses groups with the Standard doses group. Results: 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. Factors associated with a high titer level (anti-HBs ≥100 mIU/mL) were vaccination schedule and younger age. The most common adverse event was pain at the injection site (42.4%); this was significantly more frequent in the four double doses group compared to the Standard doses group. No serious adverse events were observed. Conclusions: In Northern Thailand, the standard three-doses HBV vaccination in HIV-infected adults with CD4+ cell counts >200 cells/mm3 and undetectable plasma HIV-1 RNA is highly effective. Although regimens of four injections of either standard or double doses could not significantly increase the response rate, these regimens may induce higher levels of antibody to the virus. Trial registration information: ClinicalTrials.gov; NCT1289106 © 2013 Chaiklang et al.
format Journal
author Kanokporn Chaiklang
Jiraprapa Wipasa
Romanee Chaiwarith
Jutarat Praparattanapan
Khuanchai Supparatpinyo
author_facet Kanokporn Chaiklang
Jiraprapa Wipasa
Romanee Chaiwarith
Jutarat Praparattanapan
Khuanchai Supparatpinyo
author_sort Kanokporn Chaiklang
title 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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84893000793&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/52058
_version_ 1681423881853730816