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

NCT05898464 | Completed Phase 4 DMC

• 1 other identifier: 2304-110-1426
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Vaccination; Infection; Vaccine Adverse Reaction

Keywords

Recombinant zoster vaccine; Vaccination of people living with HIV

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Cell-mediated immunogenicity

  1 month, 13 months after 2nd dose

• Differences in humoral immune response and cell mediated immunogenecity

  1 month, 13 months after 2nd dose

• Grade 3/4 adverse events (AE)

  Within 7 days (Day 0-6) after the first and second dose.

• Any serious adverse events (SAEs)

  Throughout the study period: Day 0~450 or termination, whichever came first

• Increase in HIV Viral Load or decrease in CD4+ T-cell Count

  1 month after 2nd dose

Study Arms (3)

HIV #1

EXPERIMENTAL

CD4+ T cell count \<300 cells/µL

Biological: Recombinant zoster vaccination

HIV #2

ACTIVE COMPARATOR

CD4+ T cell count≥300 cells/µL

Biological: Recombinant zoster vaccination

non-HIV

ACTIVE COMPARATOR

Healthy adult

Biological: Recombinant zoster vaccination

Interventions

Recombinant zoster vaccination BIOLOGICAL

Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart

HIV #1; HIV #2; non-HIV

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older, HIV-1 infected person who have voluntarily agreed to participate in the study.
• 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.
• years old or older who have voluntarily agreed to participate in the study.
• Do not have uncontrolled chronic medical conditions

You may not qualify if:

• Have received any type of zoster vaccine within 1 year.
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Medical Center, Seoul: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

National Medical Center

Seoul, 04564, South Korea

Location

Related Publications (12)

• 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.

  PMID: 1308664 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.

  PMID: 16186734 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.

  PMID: 29594092 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.

  PMID: 25601456 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.

  PMID: 11382367 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.

  PMID: 20190589 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.

  PMID: 27117317 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.

  PMID: 34590136 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.

  PMID: 25371534 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.

  PMID: 33225349 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.

  PMID: 24717910 BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

• Wan Beom Park, M.D., PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 12, 2023
• Study Start: June 27, 2023
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)