Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial

Rey, David; Piroth, Lionel; Wendling, Marie-Josée; Miailhes, Patrick; Michel, Marie‐Louise; Dufour, Cécilie; Haour, G.; Sogni, Philippe; Rohel, Alexandra; Ajana, F.; Billaud, Éric; Molina, Jean‐Michel; Launay, Odile; Carrat, Fabrice

doi:10.1016/s1473-3099(15)00220-0

Cited by 46 publications

(40 citation statements)

References 22 publications

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“…Different strategies have been employed to improve the response rates in immunologically compromised patients, including HIV-infected adult patients, and in patients with chronic kidney disease [4,5,6]. We designed a prospective randomized study to evaluate the efficacy of 3 different induction regimens for HBV immunization in patients with hematological malignancies.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

Suyanı¹,

Haznedar²,

Yağcı³

2016

Tjh

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Objective:Non-responsiveness to hepatitis B virus (HBV) vaccines is not rare in hemato-oncological patients due to disease-associated or treatment-induced immune suppression. Although different strategies have been employed to improve the response rates, to date there is not an approved schedule for HBV immunization in patients with hematological malignancies. We designed a prospective randomized study to evaluate the efficacy of 3 different induction regimens for HBV vaccination.Materials and Methods:In the standard-dose (SD) group, total vaccine dose delivered was 40 µg and patients were vaccinated with 20 µg at weeks 0 and 4. In the high-dose dose-intensive (HDDI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 40 µg at weeks 0 and 4. In the high-dose time-intensive (HDTI) group, total vaccine dose delivered was 80 µg and patients were vaccinated with 20 µg at weeks 0, 2, 4, and 6.Results:In a cohort of 114 patients, 38.6% responded to HBV vaccination. The response rate in the SD arm, HDDI arm, and HDTI arm was 26.2%, 29.7%, and 44.4%, respectively (p>0.05). Age was the only variable identified as having a negative impact on response.Conclusion:Short of achieving statistical significance, a higher response rate was observed in the HDTI arm. Therefore, this study supports a high-dose, time-intensive HBV vaccine induction regimen in patients with hematological malignancies who are not on chemotherapy.

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Section: Introductionmentioning

confidence: 99%

A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

Suyanı¹,

Haznedar²,

Yağcı³

2016

Tjh

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“…A study conducted in Thailand also demonstrated a high response rate of 95% by giving 4 double‐dose HBV vaccine to HIV‐positive adults with CD4 counts >200 cells/μL and undetectable PVL . However, 3 double‐dose regimen did not significantly improve serological response compared to the standard regimen among the vaccine non‐responders who underwent revaccination (74% vs 67%, P = .334) . Whether those results might be applied to HIV‐positive patients who had lost seroprotection 2 decades after neonatal HBV vaccination remains unclear.…”

Section: Discussionmentioning

confidence: 99%

Serological responses to revaccination against HBV in HIV‐positive patients born in the era of nationwide neonatal HBV vaccination

Huang

Hsieh

Sheng

et al. 2018

Liver International

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“…62 Restarting vaccination using an intensified schedule of 4 double-dose does not improve the response rate compared with the standard schedule; however, the double-dose regimen resulted in a more robust and durable immunological response, with a safety profile similar to that of the standard-dose regimen. 67 For patients who do not respond to vaccination, an annual screening for HBV markers (HBsAg, anti-HBs and anti-HBc antibodies) must be performed. The use of at least one active medication against HBV in the antiretroviral treatment of these patients is also recommended.…”

Section: Hepatitis B Vaccinementioning

confidence: 99%

Immunization of HIV-infected adult patients — French recommendations

Frésard

Gagneux‐Brunon

Lucht

et al. 2016

Human Vaccines & Immunotherapeutics

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Human immunodeficiency virus (HIV)-infected patients remain at increased risk of infection including vaccine-preventable diseases. Vaccines are therefore critical components in the protection of HIV-infected patients from an increasing number of preventable diseases. However, missed opportunities for vaccination among HIV-infected patients persist and vaccine coverage in this population could be improved. This article presents the French recommendations regarding immunization of HIV-infected adults in the light of the evidence-based literature on the benefits and the potential risks of vaccines among this vulnerable population.

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Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial

Cited by 46 publications

References 22 publications

A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies

Serological responses to revaccination against HBV in HIV‐positive patients born in the era of nationwide neonatal HBV vaccination

Immunization of HIV-infected adult patients — French recommendations

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