Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV

Summary

The purpose of this study is to compare the immunogenicity and safety of recombinant zoster vaccine according to CD4+ T-cell count and age in people living with HIV, and to provide evidence to guide immunization of people living with HIV.

Timeline

Start

2023-06-27

Primary completion

2026-02-10

Completion

2026-02-10

Publications

• Background Buchbinder SP, Katz MH, Hessol NA, Liu JY, O'Malley PM, Underwood R, Holmberg SD. Herpes zoster and human immunodeficiency virus infection. J Infect Dis. 1992 Nov;166(5):1153-6. doi: 10.1093/infdis/166.5.1153.
• Background Gebo KA, Kalyani R, Moore RD, Polydefkis MJ. The incidence of, risk factors for, and sequelae of herpes zoster among HIV patients in the highly active antiretroviral therapy era. J Acquir Immune Defic Syndr. 2005 Oct 1;40(2):169-74. doi: 10.1097/01.qai.0000178408.62675.b0.
• Background Erdmann NB, Prentice HA, Bansal A, Wiener HW, Burkholder G, Shrestha S, Tang J. Herpes Zoster in Persons Living with HIV-1 Infection: Viremia and Immunological Defects Are Strong Risk Factors in the Era of Combination Antiretroviral Therapy. Front Public Health. 2018 Mar 12;6:70. doi: 10.3389/fpubh.2018.00070. eCollection 2018.
• Background Grabar S, Tattevin P, Selinger-Leneman H, de La Blanchardiere A, de Truchis P, Rabaud C, Rey D, Daneluzzi V, Ferret S, Lascaux AS, Hanslik T, Costagliola D, Launay O; French Hospital Database on HIV (FHDH-ANRS CO4 Cohort). Incidence of herpes zoster in HIV-infected adults in the combined antiretroviral therapy era: results from the FHDH-ANRS CO4 cohort. Clin Infect Dis. 2015 Apr 15;60(8):1269-77. doi: 10.1093/cid/ciu1161. Epub 2015 Jan 18.
• Background Domingo P, Torres OH, Ris J, Vazquez G. Herpes zoster as an immune reconstitution disease after initiation of combination antiretroviral therapy in patients with human immunodeficiency virus type-1 infection. Am J Med. 2001 Jun 1;110(8):605-9. doi: 10.1016/s0002-9343(01)00703-3.
• Background Song JY, Lee JS, Jung HW, Choi HJ, Lee JS, Eom JS, Cheong HJ, Jung MH, Kim WJ. Herpes zoster among HIV-infected patients in the highly active antiretroviral therapy era: Korean HIV cohort study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):417-8. doi: 10.1097/QAI.0b013e3181b1d6dc. No abstract available.
• Background Kim YJ, Woo JH, Kim MJ, Park DW, Song JY, Kim SW, Choi JY, Kim JM, Han SH, Lee JS, Choi BY, Lee JS, Kim SS, Kee MK, Kang MW, Kim SI. Opportunistic diseases among HIV-infected patients: a multicenter-nationwide Korean HIV/AIDS cohort study, 2006 to 2013. Korean J Intern Med. 2016 Sep;31(5):953-60. doi: 10.3904/kjim.2014.322. Epub 2016 Apr 27.
• Background Harbecke R, Cohen JI, Oxman MN. Herpes Zoster Vaccines. J Infect Dis. 2021 Sep 30;224(12 Suppl 2):S429-S442. doi: 10.1093/infdis/jiab387.
• Background Berkowitz EM, Moyle G, Stellbrink HJ, Schurmann D, Kegg S, Stoll M, El Idrissi M, Oostvogels L, Heineman TC; Zoster-015 HZ/su Study Group. Safety and immunogenicity of an adjuvanted herpes zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a randomized, placebo-controlled study. J Infect Dis. 2015 Apr 15;211(8):1279-87. doi: 10.1093/infdis/jiu606. Epub 2014 Nov 3.
• Background Thompson MA, Horberg MA, Agwu AL, Colasanti JA, Jain MK, Short WR, Singh T, Aberg JA. Primary Care Guidance for Persons With Human Immunodeficiency Virus: 2020 Update by the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2021 Dec 6;73(11):e3572-e3605. doi: 10.1093/cid/ciaa1391.
• Background Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association, and Infectious Diseases Society of America. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-andadolescent-opportunistic-infection. Accessed March 31, 2023
• Background Centers for Disease Control and Prevention (CDC). Revised surveillance case definition for HIV infection--United States, 2014. MMWR Recomm Rep. 2014 Apr 11;63(RR-03):1-10.

Drugs

Indications

No indication recorded.