NCT05898464

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vaccination; Infection
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant zoster vaccination	Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart

Timeline

• Start date: 2023-06-27
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2023-06-12
• Last updated: 2025-10-02

Locations

2 sites across 1 country: South Korea