NCT05575830

Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls

Immune Response to the Recombinant Zoster Vaccine in People Living With HIV Over 50 Years of Age Compared to Non-HIV Age- and Gender-matched Controls - The Shingr'HIV Phase IV Multicenter Study

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Calmy Alexandra · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in older people (\> 50 years) living with HIV (PLWH) compared to age-matched healthy adults over a 1-year period.

Detailed description

This is a prospective multicentric phase IV study, aiming at evaluating the immunogenicity and safety profile of RZV in PLWH over 50 years of age (YOA) on long term antiretroviral therapy (ART) (\>10 years) compared to non-HIV age-matched adult controls to address the combined effect of aging and immunosuppression from HIV disease. Inclusion will be stratified as follow: HIV+ groups: * Group 1: PLWH registered in the SHCS or ANRS CO3, \>75 YOA and under cART for more than 10 years - N=50 * Group 2: PLWH patients registered in the SHCS, aged between 60 and 75 and under cART for more than 10 years - N=50 * Group 3: PLWH patients registered in the SHCS, aged between 50 and 59 and under cART for more than 10 years - N=50 Control groups: * Group 4: Healthy adults aged \>75 YOA- N=25 * Group 5: Healthy adults aged between 60 and 75 - N=25 * Group 6: Healthy adults aged between 50 and 59 - N=25 In addition, participants of all groups will be proposed to be included in the "Innate substudy" (target of 15 participants/group) and have two additional blood drawings 1 day after each vaccine dose to measure innate response triggered by RZV. Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 1, Day61, Day90, Day360. Unsolicited Adverse events of special intesrest (AESI) will be collected on Day 28, Day 60, Day90, Day360; patients reported outcomes (PROs) will be declared for one week after each vaccination.

Conditions

• RZV Vaccine (Shingrix ®)

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Zoster Vaccine	Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Timeline

• Start date: 2022-12-14
• Primary completion: 2025-04-16
• Completion: 2026-03-31
• First posted: 2022-10-12
• Last updated: 2025-09-05

Locations

10 sites across 2 countries: France, Switzerland