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Vaccination; InfectionPhase 4NCT05898464

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

A Phase 4 study testing Recombinant zoster vaccination in people with Vaccination; Infection and Vaccine Adverse Reaction, run by Seoul National University Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Recombinant zoster vaccination
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
2 sitesSouth Korea
Study dates
27 Jun 2023to 10 Feb 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 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.
  • 50 years old or older who have voluntarily agreed to participate in the study.
  • Do not have uncontrolled chronic medical conditions

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Hospital

    Seoul, 03080

  • National Medical Center

    Seoul, 04564

Other trials in South Korea

About this study

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.

Read the detailed description
  • HIV-infected individuals willing to receive recombinant zoster vaccine will be recruited at three study hospitals.
  • 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.
Being tested
Recombinant zoster vaccination
Keywords
Recombinant zoster vaccine, Vaccination of people living with HIV
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant zoster vaccinationBiological

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

Study groups in NCT05898464
Study groupRoleWhat they receive
HIV #1ExperimentalCD4+ T cell count <300 cells/µL
Receives: Biological: Recombinant zoster vaccination
HIV #2Active comparatorCD4+ T cell count≥300 cells/µL
Receives: Biological: Recombinant zoster vaccination
non-HIVActive comparatorHealthy adult
Receives: Biological: Recombinant zoster vaccination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 month, 13 months after 2nd dose

Secondary outcomes (6)

  1. 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.

    Measured: 1 month, 13 months after 2nd dose

  2. Differences in humoral immune response and cell mediated immunogenecity

    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

    Measured: 1 month, 13 months after 2nd dose

  3. Grade 3/4 adverse events (AE)

    Solicited and unsolicited local and systemic adverse events occurring within 7 days after the first and second dose

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

  4. Any serious adverse events (SAEs)

    Any serious adverse events occurring throughout the study period

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

  5. 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

    Measured: 1 month after 2nd dose

  6. 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);

    Measured: Within 3 months after 2nd dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start27 Jun 2023
  3. Primary completion10 Feb 2026
  4. Study completion10 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05898464
Sponsor's protocol ID
2304-110-1426
Status last verified
Apr 2026
First submitted
30 May 2023
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 1308664

  • 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.

    PubMed 16186734

  • 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.

    PubMed 29594092

  • 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.

    PubMed 25601456

  • 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.

    PubMed 11382367

  • 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.

    PubMed 20190589

  • 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.

    PubMed 27117317

  • 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.

    PubMed 34590136

  • 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.

    PubMed 25371534

  • 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.

    PubMed 33225349

  • 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.

    PubMed 24717910

  • Kim MK, Jo HJ, Lee CM, Kang CK, Lee CE, Oh HS, Choe PG, Park SW, Kim G, Kim Y, Chin B, Park WB, Kim NJ. Impact of CD4 T cell counts on the immunogenicity and safety of the recombinant zoster vaccine in people living with HIV. Int J Infect Dis. 2026 Sep 8;172:109100. doi: 10.1016/j.ijid.2026.109100. Online ahead of print.

    PubMed 42710800

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Recombinant zoster vaccination in people with Vaccination; Infection and Vaccine Adverse Reaction, run by Seoul National University Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral immune response (time frame: 1 month, 13 months after 2nd dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05898464, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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