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

Last updated: September 27, 2025
Sponsor: Seoul National University Hospital
Overall Status: Active - Not Recruiting

Phase

4

Condition

Shingles

Rash

Chickenpox (Varicella Zoster Infection)

Treatment

Recombinant zoster vaccination

Clinical Study ID

NCT05898464
2304-110-1426
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

  • 19 years old or older, HIV-1 infected person who have voluntarily agreed toparticipate in the study.

  • Have been taking antiviral medications stably for at least one month at the time ofscreening.

  • Have a CD4+ T-cell count measured before enrollment.

  • Do not have AIDS-defining diseases (excluding oral thrush) or acute/uncontrolledopportunistic 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

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 thefirst vaccine dose.

  • Chronic administration of immunosuppressive or other immune-modifying drugs within 6months prior to ther first vaccine dose.

  • Administration of immunoglobulins, and/or any blood products within 3 monthspreceding the first dose of study vaccine

  • Have a medical condition that makes receiving an intramuscular injection medicallycontraindicated.

  • Have a disease or condition that may affect the immunogenicity or safety of thevaccine.

  • Receiving any other vaccine within 14 days prior to and 14 days after receiving thestudy vaccine.

  • Participate in a clinical trial that involves other investigational product ordevice during the course of the study.

  • Any other person who, in the opinion of the investigator, is unsuitable for immuneresponse assessment.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Recombinant zoster vaccination
Phase: 4
Study Start date:
June 27, 2023
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • National Medical Center

    Seoul, 04564
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • National Medical Center

    Seoul 1835848, 04564
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.