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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: RZV Vaccine (Shingrix ®)
• Intervention / Treatment: Biological: Recombinant Zoster Vaccine

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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bordeaux
    • Bordeaux, Bordeaux, France, 33075
      • Hôpital Saint-André, CHU de Bordeaux
  • France
    • Bordeaux, France, France, 33000
      • SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
  • Gironde
    • Pessac, Gironde, France, 33604
      • Chu de Bordeaux - Hopital Haut-Leveque
• Switzerland
  • Basel
    • Basel, Basel, Switzerland, 4031
      • University Hospital Basel
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Ente Ospedaliero Cantonale
  • Canton of Bern
    • Bern, Canton of Bern, Switzerland, 3010
      • Bern University Hospital (Inselspital)
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • University Hospitals of Geneva
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Kantonsspital
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudoise (CHUV)
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For PLWH:

• Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort
• Age >50 YOA
• Time since cART initiation > 10 years
• Not already vaccinated with RZV
• HIV viral load <50 copies/ml (within 6 months from the last blood sampling)
• Informed consent as documented by signature
• (France) : Person affiliated with or beneficiary of the French social security scheme

For aged/gender-matched controls

• Age >50 YOA
• Not already vaccinated with RZV
• Informed consent as documented by signature
• (France) Not HIV infected
• (France) Person affiliated with or beneficiary of the French social security scheme

Exclusion Criteria:

• Ongoing signs of febrile or non-febrile infection at the time of the first vaccination

• Immunosuppression from the following:

  • Current malignant neoplasm;
  • primary immunodeficiency;
  • recent (<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy
• Intake of drugs which suppress the immune system (e.g. glucocorticoids for a long time [an equivalent dose of prednisolone >20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening.
• Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period
• Having received a vaccine in the last month or is expected to receive a vaccine in the next month
• Having received a shingles vaccine within one year
• Presented with herpes zoster in the previous year
• Contra-indication to RZV
• Hospitalized patients
• Unable to provide informed consent or inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Participation in another study with investigational drug within the 30 days preceding and during the present study.
• (France) Pregnant or breastfeeding woman
• (France) Patient governed by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RZV or Shingrix®); Recombinant Zoster Vaccine	Biological: Recombinant Zoster Vaccine; Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60; Other Names: (Shingrix® )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean titer (GMT) of gE-specific total IgG	gE-specific total IgG titers is determined by gE-specific ELISA from sera samples	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine safety - AESI 7 days	Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card	7 days
Vaccine safety - SAE 360 days	Incidence of SAE throughout the study period	360 days
Vaccine safety -pIMDs	Incidence of potential immune mediated disorders (pIMDs) throughout the study period	360 days
Vaccine safety - PLWH	In PLWH: Percentage of PLWH with viral load >50 copies/ml one month after the second RZV vaccination (D90)	Day 90
Vaccine immunogenicity - CD4+ T cells	Mean of gE-specific CD4+ T cells expressing at least 2 activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) per million of T cells, measured at D90	Day 90

Collaborators and Investigators

• Sponsor: Calmy Alexandra
• Investigators: Study Director: Alexandra Calmy, Prof. MD, University Hospitals of Geneva, Infectious disease department,

Publications and helpful links

General Publications

• Hentzien M, Bonnet F, Bernasconi E, Biver E, Braun DL, Munting A, Leuzinger K, Leleux O, Musardo S, Prendki V, Schmid P, Staehelin C, Stoeckle M, Walti CS, Wittkop L, Appay V, Didierlaurent AM, Calmy A. Immune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol. BMC Infect Dis. 2024 Mar 19;24(1):329. doi: 10.1186/s12879-024-09192-5.

Helpful Links

• Shingrix vaccine information

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): April 16, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Immune response; PLWH; RZV vaccine
• Other Study ID Numbers: 2022-01314; 2023-504482-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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