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Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.

ABSTRACT: BACKGROUND:Presence of isolated anti-HBc antibody is common in HIV-infected patients in endemic areas and could be caused by prior HBV infection with loss of anti-HBs antibody. The role of vaccination in these patients remains controversial and is based largely on limited and low quality data. We, therefore, conducted this study to determine immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody. METHODS:An open-label, randomized controlled trial was conducted among HIV-infected patients visiting HIV clinic of the Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand between July and September 2017. Inclusion criteria included ??18 years of age, currently on a stable antiretroviral regimen, CD4+ cell count ??200 cells/mm3, plasma HIV-1 RNA

SUBMITTER: Laksananun N

PROVIDER: S-EPMC6498566 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.

Laksananun Nattinee N Praparattanapan Jutarat J Kotarathititum Wilai W Supparatpinyo Khuanchai K Chaiwarith Romanee R

AIDS research and therapy 20190503 1

<h4>Background</h4>Presence of isolated anti-HBc antibody is common in HIV-infected patients in endemic areas and could be caused by prior HBV infection with loss of anti-HBs antibody. The role of vaccination in these patients remains controversial and is based largely on limited and low quality data. We, therefore, conducted this study to determine immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.<h4>Methods</h4>An ope ...[more]

PMID: 31053142

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Project description:BackgroundHBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm(3) 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.MethodsFrom February 4, 2011 to May 4, 2012, 132 HIV-infected adults with CD4+ cell counts >200 cells/mm(3), 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 ?g IM at months 0, 1, and 6 (Standard doses group, n=44), 20 ?g IM at months 0, 1, 2, 6 (four doses group, n=44), or 40 ?g 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.ResultsAt 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.ConclusionsIn Northern Thailand, the standard three-doses HBV vaccination in HIV-infected adults with CD4+ cell counts >200 cells/mm(3) 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 informationClinicalTrials.gov; NCT1289106; http://clinicaltrials.gov/ct2/show/NCT01289106.

Project description:BackgroundWe previously reported that four doses or four double doses of hepatitis B vaccination regimens could not significantly increase a response rate compared with standard doses. However, the antibody levels were higher in the four doses and four double doses groups. This study followed those patients for at least 3 years and aimed to evaluate the immunogenicity of the three vaccination regimens.MethodsHIV-infected adults who had CD4+ cell counts > 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all hepatitis B virus markers were randomly assigned to receive one of three recombinant vaccines (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) between February 2011 and May 4, 2012. Of 132 participants, 126 were evaluated from August 2015 to January 2016; 42 in the standard doses, 43 in the four doses, and 41 in the four double doses groups.ResultsAt a median duration of 49.7 months (range 46.7-53.7) after completion of the primary vaccination schedule, the percentages of responders with anti-HBs ≥ 10 mIU/mL were 57.1% (95% CI 41.5-72.8%) in the standard doses group; 76.7% (95% CI 63.6-89.9%) in the four doses group (P = 0.067 vs. the standard doses group); and 80.5% (95% CI 67.8-93.2%) in the four double doses group (P = 0.033 vs. the standard doses group). Factors associated with a responder were the vaccination schedule (either four doses or four double doses groups) and a younger age.ConclusionsDespite the highly effectiveness of the standard hepatitis B vaccination regimen at 6 months after completion, the long-term immunogenicity was lower than the four double doses regimen among HIV-infected adults with CD4+ cell counts > 200 cells/mm3 and undetectable plasma HIV-1 RNA. The standard vaccination regimen may not be the best strategy to provide long-term immune response against hepatitis B virus among HIV-infected individuals. Trial registration NCT1289106, NCT02713620.

Project description:BACKGROUND:Due to numerous blood exposures hospital staff are at risk of acquiring hepatitis B virus (HBV) infections. This study aimed at estimating prevalence of HBV, associated risk factors and HBV vaccination among Polish health care workers (HCWs). METHODS:A cross-sectional sero-survey was conducted (October 2016-January 2018) in 10 randomly selected hospitals from two provinces: of low and high incidence of HBV, with the use of an anonymous, self- administered questionnaire. Blood samples were screened for hepatitis B core antibodies (anti-HBc) with enzyme immunoassay. RESULTS:Of the 306 participating HCWs, 88.6% were females, 69.9% nurses (mean age 47.8?±?9.0?years). HBV vaccination was reported by 94.2%, participants (4.7% with 2 doses, 58.1% with 3 doses, 37.2% took a booster), but of these 75.1% reported no post-immunization serology. The sero-prevalence of anti-HBc was 12.1% (95%CI 8.4-15.7%); only 11.1% had ever screened themselves for HBV infection. Out of 37 anti-HBc positive HCWs, 29 reported being vaccinated for HBV; 10.5% vaccinated HCWs were anti-HBc positive. Regarding other occupational risk factors, 27.8% had experienced a sharp injury (SI) in the last year, 80.0% of incidents were not reported. The use of safety devices (SD) was 86.3%; 35.9% participants used to recap a needle. Older age (OR?=?4.24), lack of HBV vaccination (OR?=?7.42), working at the province of high HBV incidence in the general population (OR?=?2.69) were each predictors of participant's HBV infection. CONCLUSIONS:High anti-HBc seroprevalence was found in hospital staff with older generation particularly constituting a risk group. Unsatisfactory vaccination coverage and the use of SDs, needle recapping and under-reporting of SIs were main modifiable risk factors regarding HBV infection. The study provides evidence of the protective role of HBV vaccine, as well as the possible effect of HBV incidence in the general population on HCW's anti-HBc seropositivity. Universal vaccination, followed by strict policies to confirm immunity, better compliance with infection-control practices and widespread implementation of SDs should be enforced to protect hospital staff from occupationally acquired HBV infections.

Dataset Information

Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.

Publications

Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.

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