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

Last updated: February 8, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Rash

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 within one month of screening.
  • 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 months precedingthe 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 or deviceduring 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

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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.