Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial

References

• AIDSinfo UNAIDS. Fact sheet-Latest global and regional statistics on the status of the AIDS epidemic. [EB/OL]. (2021August17). https://www.unaids.org/en/resources/fact-sheet.
   Google Scholar
• National Health Commission of the People’s Republic of China. National. notifiable diseases overview in 2020. [cited 2021 June 13]. Available from: http://www.nhc.gov.cn/jkj/s3578/202103/f1a448b7df7d4760976fea6d55834966.shtml .
   Google Scholar
• Ganesan M, Poluektova LY, Kharbanda KK, et al. Human immunodeficiency virus and hepatotropic viruses co-morbidities as the inducers of liver injury progression. World J Gastroenterol. 2019;25(4):398–410.
   PubMed Web of Science ®Google Scholar
• Dan F. The prevalence and related factors of HBV/HCV coinfection in HIV/AIDS adults in China: systematic review and meta-analysis. Taiyuan: Shanxi Medical University; 2018.
   Google Scholar
• Thio CL, Seaberg EC, Skolasky R, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the multicenter cohort study (MACS). Lancet. 2002;360(9349):1921–1926.
   PubMed Web of Science ®Google Scholar
• Sarmati L, Malagnino V. HBV Infection in HIV-driven immune suppression. Viruses. 2019;11(11):1077.
   PubMed Web of Science ®Google Scholar
• Konopnicki D, Mocroft A, Wit SD, et al. Hepatitis B and HIV prevalence, AIDS progression, response to highly active antiretroviral therapy and increased mortality in the EuroSIDA cohort. AIDS. 2005;19(6):593–601.
   PubMed Web of Science ®Google Scholar
• Kourtis AP, Bulterys M, Hu DJ, et al. HIV-HBV coinfection-a global challenge. N Engl J Med. 2012;366(19):1749–1752.
   PubMed Web of Science ®Google Scholar
• Tsai MS, Chang SY, Lo YC, et al. Hepatitis B virus (HBV) coinfection accelerates immunologic progression in patients with primary HIV infection in an area of hyperendemicity for HBV infection. J Infect Dis. 2013;208(7):1184–1186.
   PubMed Web of Science ®Google Scholar
• WHO. Hepatitis B. [cited 2021 June 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
   Google Scholar
• Lee JH, Hong S, Im JH, et al., Systematic review and meta-analysis of immune response of double dose of hepatitis B vaccination in HIV-infected patients. Vaccine. 38(24): 3995–4000. 2020.
   PubMed Web of Science ®Google Scholar
• Fonseca MO, Pang LW, Cavalheiro NDP, et al. Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose. Vaccine. 2005;23(22):2902–2908.
   PubMed Web of Science ®Google Scholar
• Rey D, Piroth L, Wendling MJ, et al. 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. Lancet Infect Dis. 2015;15(11):1283–1291.
   PubMed Web of Science ®Google Scholar
• Flynn PM, Cunningham CK, Rudy B, et al. Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens. J Acquir Immune Defic Syndr. 2011;56(4):325–332.
   PubMed Web of Science ®Google Scholar
• Laksananun N, Praparattanapan J, Kotarathititum W, et al., Immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody. AIDS Res Ther. 16(1): 10. 2019.
   PubMed Web of Science ®Google Scholar
• Chaiklang K, Wipasa J, Chaiwarith R, et al., 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. PLoS One. 8(11): e80409. 2013.
   PubMed Web of Science ®Google Scholar
• Launay O, Vliet DVD, Rosenberg AR, et al., Safety and immunogenicity of 4 intramuscular double doses and 4 intradermal low doses vs standard hepatitis B vaccine regimen in adults with HIV-1: a randomized controlled trial. JAMA. 305(14): 1432–1440. 2011.
   PubMed Web of Science ®Google Scholar
• Chinese Society of Infectious Diseases, Chinese Society of Hepatology, Chinese Medical Association. The guidelines of prevention and treatment for chronic hepatitis B (2019 version). Zhonghua Gan Zang Bing Za Zhi. 2019;27(12):938–961.
   PubMedGoogle Scholar
• Feng Y, Yao T, Chang Y, et al., Immunogenicity and persistence of high-dose recombinant hepatitis B vaccine in adults infected with human immunodeficiency virus in China: a randomized, double-blind, parallel controlled trial. Vaccine. 39(27): 3582–3589. 2021.
   PubMed Web of Science ®Google Scholar
• CFDA. The standard guidelines for adverse reactions grading of vaccine clinical trials. China food and drug administration. [cited 2021 July 3]. Available from: http://www.sda.gov.cn/WS01/ CL0844/9350_5.html
   Google Scholar
• Lopes VB, Hassing RJ, de Vries-sluijs TE, et al. Long-term response rates of successful hepatitis B vaccination in HIV-infected patients. Vaccine. 2013;31(7):1040–1044.
   PubMed Web of Science ®Google Scholar
• Nicolini LA, Magne F, Signori A, et al. Hepatitis B virus vaccination in HIV: immunogenicity and persistence of seroprotection up to 7 years following a primary immunization course. AIDS Res Hum Retroviruses. 2018;34(11):922–928.
   PubMed Web of Science ®Google Scholar
• Douek DC, Picker LJ, Koup RA. T cell dynamics in HIV-1 infection. Annu Rev Immunol. 2003;21(1):265–304.
   PubMedGoogle Scholar
• Veiga AP, Casseb J, Duarte AJ. Humoral response to hepatitis B vaccination and its relationship with T CD45RA+ (naive) and CD45RO+ (memory) subsets in HIV-1-infected subjects. Vaccine. 2006;24(49–50):7124–7128.
   PubMed Web of Science ®Google Scholar
• Pettit NN, DePestel DD, Malani PN, et al. Factors associated with seroconversion after standard dose hepatitis B vaccination and high-dose revaccination among HIV-infected patients. HIV Clin Trials. 2010;11(6):332–339.
   PubMed Web of Science ®Google Scholar
• Seremba E, Ocama P, Ssekitoleko R, et al. Immune response to the hepatitis B vaccine among HIV-infected adults in Uganda. Vaccine. 2021 22; 39(8): 1265–1271.
   PubMed Web of Science ®Google Scholar
• Kim H, Harrington R, Crane H, et al. Hepatitis B vaccination in HIV-infected adults: current evidence, recommendations and practical considerations. Int J STD AIDS. 2009;20(9):595–600.
   PubMed Web of Science ®Google Scholar
• Catherine F, Piroth L. Hepatitis B virus vaccination in HIV-infected people: a review. Hum Vaccin Immunother. 2017;13(6):1–10.
   PubMed Web of Science ®Google Scholar