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| Name | Class |
|---|---|
| National Medical Center, Seoul | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV #1 | Experimental | CD4+ T cell count <300 cells/µL |
|
| HIV #2 | Active Comparator | CD4+ T cell count≥300 cells/µL |
|
| non-HIV | Active Comparator | Healthy adult |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant zoster vaccination | Biological | Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response | Defined as a 4-fold or greater increase in anti-VZV antibody concentration from pre-vaccination testing in seropositive subjects and a 4-fold or greater increase in anti-gE antibody concentration from the cutoff in seronegative subjects prior to vaccination. | 1 month, 13 months after 2nd dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cell-mediated immunogenicity | Defined as a 2-fold or greater increase in CD4+ T cells expressing at least two activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) post-vaccination compared to pre-vaccination baseline. | 1 month, 13 months after 2nd dose |
| Differences in humoral immune response and cell mediated immunogenecity |
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Inclusion Criteria (for HIV #1, HIV #2) :
Inclusion Criteria (for non-HIV) :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan Beom Park, M.D., PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea | |||
| National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1308664 | 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. | |
| 16186734 | 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. |
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We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.
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| ID | Term |
|---|---|
| D007239 | Infections |
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Comparison of geometric mean of anti VZV IgG titer and proportions of VZV-specific CD4+ and CD8+ T-cells between HIV#1 and HIV#2 |
| 1 month, 13 months after 2nd dose |
| Grade 3/4 adverse events (AE) | Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose | Within 7 days (Day 0-6) after the first and second dose. |
| Any serious adverse events (SAEs) | Any serious adverse events occurring throughout the study period | Throughout the study period: Day 0~450 or termination, whichever came first |
| Increase in HIV Viral Load or decrease in CD4+ T-cell Count | Increase in HIV Viral Load by 0.5 log or more or decrease in CD4+ T-cell Count by 30% or more | 1 month after 2nd dose |
| Any AIDS-defining disease | Occurrence of any AIDS defining condition according to the appendix of the "Revised surveillance case definition for HIV infection--United States, 2014" (Centers for Disease Controls and Prevention); | Within 3 months after 2nd dose |
| Seoul |
| 04564 |
| South Korea |
| 29594092 | 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. |
| 25601456 | 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. |
| 11382367 | 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. |
| 20190589 | 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. |
| 27117317 | 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. |
| 34590136 | 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. |
| 25371534 | 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. |
| 33225349 | 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 |
| 24717910 | 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. |