Immunogenicity and Safety of Recombinant Zoster Vaccine in People Living With HIV
NCT ID: NCT05898464
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2023-06-27
2026-03-31
Brief Summary
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Detailed Description
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* Participants are divided into two groups based on HIV status and CD4+ T cell count (HIV #1: CD4+ T cell count \<300 cells/µL, HIV #2: CD4+ T cell count≥300 cells/µL, non-HIV).
* Target numbers are 50 for each group.
* Give 2 intramuscular doses of recombinant zoster vaccine 2 months apart.
* Contact by phone on days 3 and 7 after each dose to assess for adverse events.
* Evaluate immunogenicity at 1 month and 13 months after the second dose and safety.
* An interim analysis is planned after the first approximately 30 participants of HIV group and 10 participants of non-HIV group complete a visit 13 months after 2nd dose.
* Evaluation for the safety is planned after the first approximately 10 participants of the HIV #2 arm complete a visit 13 months after 2nd dose.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HIV #1
CD4+ T cell count \<300 cells/µL
Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
HIV #2
CD4+ T cell count≥300 cells/µL
Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
non-HIV
Healthy adult
Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Interventions
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Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Eligibility Criteria
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Inclusion Criteria
* Have been taking antiviral medications stably for at least one month at the time of screening.
* Have a CD4+ T-cell count measured before enrollment.
* Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolled opportunistic infection at the time of enrollment.
* Do not have uncontrolled chronic medical conditions other than HIV infection.
* 50 years old or older who have voluntarily agreed to participate in the study.
* Do not have uncontrolled chronic medical conditions
Exclusion Criteria
* Have been diagnosed with chickenpox or shingles within 12 months.
* Have a history of severe allergy to any of the components of Shingrix vaccine.
* Have a acute medical condition at the time of screening.
* Unable to be evaluated for adverse events via telephone contact after vaccination.
* Pregnant (including those planning to become pregnant) or lactating women.
* Those who have received chemotherapy or radiotherapy within 6 months prior to the first vaccine dose.
* Chronic administration of immunosuppressive or other immune-modifying drugs within 6 months prior to ther first vaccine dose.
* Administration of immunoglobulins, and/or any blood products within 3 months preceding the first dose of study vaccine
* Have a medical condition that makes receiving an intramuscular injection medically contraindicated.
* Have a disease or condition that may affect the immunogenicity or safety of the vaccine.
* Receiving any other vaccine within 14 days prior to and 14 days after receiving the study vaccine.
* Participate in a clinical trial that involves other investigational product or device during the course of the study.
* Any other person who, in the opinion of the investigator, is unsuitable for immune response assessment.
19 Years
ALL
No
Sponsors
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National Medical Center, Seoul
OTHER
SMG-SNU Boramae Medical Center
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Wan Beom Park
Professor
Principal Investigators
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Wan Beom Park, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Other Identifiers
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2304-110-1426
Identifier Type: -
Identifier Source: org_study_id
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