Intradermal Hepatitis B Vaccination in Non-responder People Living with Human Immunodeficiency Virus in Japan
We performed a pilot study to assess the immunogenicity and safety of intradermal hepatitis B (HB) virus vaccines in people living with HIV (PLWH). This single-center prospective study was conducted in Yokohama, Japan. Adult PLWH with serum antibodies against HB surface antigen (anti-HBs) <10 mIU...
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| Published in | Japanese Journal of Infectious Diseases Vol. 75; no. 5; pp. 519 - 522 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
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Tokyo
National Institute of Infectious Diseases, Japanese Journal of Infectious Diseases Editorial Committee
30.09.2022
Japan Science and Technology Agency |
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| Abstract | We performed a pilot study to assess the immunogenicity and safety of intradermal hepatitis B (HB) virus vaccines in people living with HIV (PLWH). This single-center prospective study was conducted in Yokohama, Japan. Adult PLWH with serum antibodies against HB surface antigen (anti-HBs) <10 mIU/mL at all time points after standard HB vaccination were included. We administered HB surface antigen (total dose of 10 μg) at 5 separate sites intradermally at baseline, one month, and 6–9 months and measured anti-HBs 1–3 months after administration. Eleven PLWH were included in this study. The mean age was 36 years, and all patients were men. At baseline, all patients were on antiretroviral therapy, and the mean CD4+ lymphocyte count was 588 /μL and plasma HIV-RNA was <20 copies/mL, except for one patient. Anti-HB levels were elevated to >10 mIU/mL in one patient after one dose, 6 patients after 2 doses, and 4 patients after 3 doses of the intradermal vaccines. Eight patients experienced grade 1 local adverse events. Additional vaccination via the intradermal route induced an anti-HBs level >10 mIU/mL in all patients, without serious adverse events. |
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| AbstractList | We performed a pilot study to assess the immunogenicity and safety of intradermal hepatitis B (HB) virus vaccines in people living with HIV (PLWH). This single-center prospective study was conducted in Yokohama, Japan. Adult PLWH with serum antibodies against HB surface antigen (anti-HBs) <10 mIU/mL at all time points after standard HB vaccination were included. We administered HB surface antigen (total dose of 10 μg) at 5 separate sites intradermally at baseline, one month, and 6–9 months and measured anti-HBs 1–3 months after administration. Eleven PLWH were included in this study. The mean age was 36 years, and all patients were men. At baseline, all patients were on antiretroviral therapy, and the mean CD4+ lymphocyte count was 588 /μL and plasma HIV-RNA was <20 copies/mL, except for one patient. Anti-HB levels were elevated to >10 mIU/mL in one patient after one dose, 6 patients after 2 doses, and 4 patients after 3 doses of the intradermal vaccines. Eight patients experienced grade 1 local adverse events. Additional vaccination via the intradermal route induced an anti-HBs level >10 mIU/mL in all patients, without serious adverse events. We performed a pilot study to assess the immunogenicity and safety of intradermal hepatitis B (HB) virus vaccines in people living with HIV (PLWH). This single-center prospective study was conducted in Yokohama, Japan. Adult PLWH with serum antibodies against HB surface antigen (anti-HBs) <10 mIU/mL at all time points after standard HB vaccination were included. We administered HB surface antigen (total dose of 10 μg) at 5 separate sites intradermally at baseline, one month, and 6-9 months and measured anti-HBs 1-3 months after administration. Eleven PLWH were included in this study. The mean age was 36 years, and all patients were men. At baseline, all patients were on antiretroviral therapy, and the mean CD4+ lymphocyte count was 588 /μL and plasma HIV-RNA was <20 copies/mL, except for one patient. Anti-HB levels were elevated to >10 mIU/mL in one patient after one dose, 6 patients after 2 doses, and 4 patients after 3 doses of the intradermal vaccines. Eight patients experienced grade 1 local adverse events. Additional vaccination via the intradermal route induced an anti-HBs level >10 mIU/mL in all patients, without serious adverse events.We performed a pilot study to assess the immunogenicity and safety of intradermal hepatitis B (HB) virus vaccines in people living with HIV (PLWH). This single-center prospective study was conducted in Yokohama, Japan. Adult PLWH with serum antibodies against HB surface antigen (anti-HBs) <10 mIU/mL at all time points after standard HB vaccination were included. We administered HB surface antigen (total dose of 10 μg) at 5 separate sites intradermally at baseline, one month, and 6-9 months and measured anti-HBs 1-3 months after administration. Eleven PLWH were included in this study. The mean age was 36 years, and all patients were men. At baseline, all patients were on antiretroviral therapy, and the mean CD4+ lymphocyte count was 588 /μL and plasma HIV-RNA was <20 copies/mL, except for one patient. Anti-HB levels were elevated to >10 mIU/mL in one patient after one dose, 6 patients after 2 doses, and 4 patients after 3 doses of the intradermal vaccines. Eight patients experienced grade 1 local adverse events. Additional vaccination via the intradermal route induced an anti-HBs level >10 mIU/mL in all patients, without serious adverse events. |
| ArticleNumber | JJID.2021.834 |
| Author | Tachikawa, Natsuo Sasaki, Hiroaki Miyata, Nobuyuki Yoshimura, Yukihiro |
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| Cites_doi | 10.1086/433180 10.1086/524690 10.1016/S0264-410X(99)00389-8 10.1016/j.jdermsci.2015.11.008 10.1016/j.vaccine.2018.11.072 10.1016/j.aohep.2019.03.012 10.11150/kansenshogakuzasshi1970.68.854 10.1016/j.vaccine.2012.12.047 10.1001/jama.2011.351 10.5009/gnl.2012.6.1.86 |
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| References | 13. Yasumura S, Shimizu Y, Yasuyama T, et al. Intradermal hepatitis B virus vaccination for low- or non-responded health-care workers. Acta Med Okayama. 1991;45:457-459. 5. Rech-Medeiros AF, Marcon PDS, Tovo CdV, et al. Evaluation of response to hepatitis B virus vaccine in adults with human immunodeficiency virus. Ann Hepatol. 2019;18:725-729. 7. National Institute of Infectious Diseases, Japan. Fact sheet on hepatitis B vaccines. Available at <https://www.mhlw.go.jp/stf2/shingi2/2r9852000000bx23-att/2r9852000000bxqf.pdf> Accessed October 25, 2021. Japanese. 14. Kashiwagi S, Hayashi J, Ikematsu H, et al. A four year follow-up study of recombinant HB vaccine. Kansenshogaku Zasshi. 1994;68:854-860. Japanese. 16. Denis M, Knezevic I, Wilde H, et al. An overview of the immunogenicity and effectiveness of current human rabies vaccines administered by intradermal route. Vaccine 2019;37 Suppl 1:A99-A106. 2. U.S. Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Available at <https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/hepatitis-b-0?view=full>. Accessed August 29, 2022. 9. Kim JH, Psevdos Jr G, Groce V, et al. Persistence of protective hepatitis B surface antibody titers after successful double-dose hepatitis B virus rescue vaccination in HIV-infected patients. Gut Liver. 2012;6:86-91. 18. Lopes VB, Hassing RJ, de Vries-Sluijs TEMS, et al. Long-term response rates of successful hepatitis B vaccination in HIV-infected patients. Vaccine. 2013;31:1040-1044. 1. World Health Organization (WHO). HIV and hepatitis coinfections. Available at <https://www.who.int/news-room/fact-sheets/detail/hepatitis-b>. Accessed August 29, 2022. 4. Overton ET, Sungkanuparph S, Powderly WG, et al. Undetectable plasma HIV RNA load predicts success after hepatitis B vaccination in HIV-infected persons. Clin Infect Dis. 2005;41:1045-1048. 10. de Vries-Sluijs TEMS, Hansen BE, van Doornum GJJ, et al. A prospective open study of the efficacy of high-dose recombinant hepatitis B rechallenge vaccination in HIV-infected patients. J Infect Dis. 2008;197:292-294. 12. Ono K, Kashiwagi S. Complete seroconversion by low-dose intradermal injection of recombinant hepatitis B vaccine in hemodialysis patients. J Jpn Soc Dial Ther. 1990;23:189-193. Japanese. 3. Imamura A, Endo T, Konishi M, et al. HIV Treatment Guidelines March 2022 version. Available at <https://hiv-guidelines.jp/2022/part01.htm>. Accessed August 29, 2022. Japanese. 11. Rey D, Krantz V, Partisani M, et al. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. effects on HIV-1 viral load. Vaccine. 2000;18:1161-1165. 6. MSD K.K. HEPTAVAX-II package insert. Available at <https://www.msdconnect.jp/wp-content/uploads/sites/5/2021/02/pi_heptavax2_sr.pdf>. Accessed August 29, 2022. Japanese. 8. Launay O, van der Vliet D, 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. 2011;305:1432-1440. 15. Tozuka M, Oka T, Jounai N, et al. Efficient antigen delivery to the draining lymph nodes is a key component in the immunogenic pathway of the intradermal vaccine. J Dermatol Sci. 2016;82:38-45. 17. World Health Organization (WHO). Rabies vaccines: WHO position paper – April 2018. Available at <https://www.who.int/publications/i/item/who-wer9316> Accessed August 3, 2021. 11 12 13 14 15 16 17 18 1 2 3 4 5 6 7 8 9 10 |
| References_xml | – reference: 9. Kim JH, Psevdos Jr G, Groce V, et al. Persistence of protective hepatitis B surface antibody titers after successful double-dose hepatitis B virus rescue vaccination in HIV-infected patients. Gut Liver. 2012;6:86-91. – reference: 17. World Health Organization (WHO). Rabies vaccines: WHO position paper – April 2018. Available at <https://www.who.int/publications/i/item/who-wer9316> Accessed August 3, 2021. – reference: 18. Lopes VB, Hassing RJ, de Vries-Sluijs TEMS, et al. Long-term response rates of successful hepatitis B vaccination in HIV-infected patients. Vaccine. 2013;31:1040-1044. – reference: 6. MSD K.K. HEPTAVAX-II package insert. Available at <https://www.msdconnect.jp/wp-content/uploads/sites/5/2021/02/pi_heptavax2_sr.pdf>. Accessed August 29, 2022. Japanese. – reference: 7. National Institute of Infectious Diseases, Japan. Fact sheet on hepatitis B vaccines. Available at <https://www.mhlw.go.jp/stf2/shingi2/2r9852000000bx23-att/2r9852000000bxqf.pdf> Accessed October 25, 2021. Japanese. – reference: 13. Yasumura S, Shimizu Y, Yasuyama T, et al. Intradermal hepatitis B virus vaccination for low- or non-responded health-care workers. Acta Med Okayama. 1991;45:457-459. – reference: 3. Imamura A, Endo T, Konishi M, et al. HIV Treatment Guidelines March 2022 version. Available at <https://hiv-guidelines.jp/2022/part01.htm>. Accessed August 29, 2022. Japanese. – reference: 4. Overton ET, Sungkanuparph S, Powderly WG, et al. Undetectable plasma HIV RNA load predicts success after hepatitis B vaccination in HIV-infected persons. Clin Infect Dis. 2005;41:1045-1048. – reference: 16. Denis M, Knezevic I, Wilde H, et al. An overview of the immunogenicity and effectiveness of current human rabies vaccines administered by intradermal route. Vaccine 2019;37 Suppl 1:A99-A106. – reference: 14. Kashiwagi S, Hayashi J, Ikematsu H, et al. A four year follow-up study of recombinant HB vaccine. Kansenshogaku Zasshi. 1994;68:854-860. Japanese. – reference: 2. U.S. Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Available at <https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/hepatitis-b-0?view=full>. Accessed August 29, 2022. – reference: 12. Ono K, Kashiwagi S. Complete seroconversion by low-dose intradermal injection of recombinant hepatitis B vaccine in hemodialysis patients. J Jpn Soc Dial Ther. 1990;23:189-193. Japanese. – reference: 15. Tozuka M, Oka T, Jounai N, et al. Efficient antigen delivery to the draining lymph nodes is a key component in the immunogenic pathway of the intradermal vaccine. J Dermatol Sci. 2016;82:38-45. – reference: 10. de Vries-Sluijs TEMS, Hansen BE, van Doornum GJJ, et al. A prospective open study of the efficacy of high-dose recombinant hepatitis B rechallenge vaccination in HIV-infected patients. J Infect Dis. 2008;197:292-294. – reference: 11. Rey D, Krantz V, Partisani M, et al. Increasing the number of hepatitis B vaccine injections augments anti-HBs response rate in HIV-infected patients. effects on HIV-1 viral load. Vaccine. 2000;18:1161-1165. – reference: 5. Rech-Medeiros AF, Marcon PDS, Tovo CdV, et al. Evaluation of response to hepatitis B virus vaccine in adults with human immunodeficiency virus. Ann Hepatol. 2019;18:725-729. – reference: 1. World Health Organization (WHO). HIV and hepatitis coinfections. Available at <https://www.who.int/news-room/fact-sheets/detail/hepatitis-b>. Accessed August 29, 2022. – reference: 8. Launay O, van der Vliet D, 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. 2011;305:1432-1440. – ident: 2 – ident: 17 – ident: 3 – ident: 4 doi: 10.1086/433180 – ident: 10 doi: 10.1086/524690 – ident: 11 doi: 10.1016/S0264-410X(99)00389-8 – ident: 15 doi: 10.1016/j.jdermsci.2015.11.008 – ident: 1 – ident: 12 – ident: 16 doi: 10.1016/j.vaccine.2018.11.072 – ident: 5 doi: 10.1016/j.aohep.2019.03.012 – ident: 14 doi: 10.11150/kansenshogakuzasshi1970.68.854 – ident: 18 doi: 10.1016/j.vaccine.2012.12.047 – ident: 13 – ident: 8 doi: 10.1001/jama.2011.351 – ident: 9 doi: 10.5009/gnl.2012.6.1.86 – ident: 6 – ident: 7 |
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| SubjectTerms | Adverse events Antibodies Antigens Antiretroviral agents Antiretroviral therapy CD4 antigen Cell number Hepatitis Hepatitis B HIV Human immunodeficiency virus Immunization Immunogenicity intradermal Lymphocytes non-responder Patients Public health vaccine Vaccines |
| Title | Intradermal Hepatitis B Vaccination in Non-responder People Living with Human Immunodeficiency Virus in Japan |
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