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

April 22, 2026 updated by: Wan Beom Park, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 04564
        • National medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (for HIV #1, HIV #2) :

  • 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.

Inclusion Criteria (for non-HIV) :

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV #1
CD4+ T cell count <300 cells/µL
Biological: Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Active Comparator: HIV #2
CD4+ T cell count≥300 cells/µL
Biological: Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart
Active Comparator: non-HIV
Healthy adult
Biological: Recombinant zoster vaccination
Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral immune response
Time Frame: 1 month, 13 months after 2nd dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade 3/4 adverse events (AE)
Time Frame: Within 7 days (Day 0-6) after the first and second dose.
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.
Increase in HIV Viral Load or decrease in CD4+ T-cell Count
Time Frame: 1 month after 2nd dose
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
Time Frame: Within 3 months after 2nd dose
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
Cell-mediated immunogenicity
Time Frame: 1 month, 13 months after 2nd dose
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
Time Frame: 1 month, 13 months after 2nd dose
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
Any serious adverse events (SAEs)
Time Frame: Throughout the study period: Day 0~450 or termination, whichever came first
Any serious adverse events occurring throughout the study period
Throughout the study period: Day 0~450 or termination, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center
National Medical Center, Seoul

Investigators

  • Principal Investigator: Wan Beom Park, M.D., PhD., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Actual)

February 10, 2026

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2304-110-1426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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