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

Last updated: April 8, 2025
Sponsor: Calmy Alexandra
Overall Status: Active - Not Recruiting

Phase

4

Condition

N/A

Treatment

Recombinant Zoster Vaccine

Clinical Study ID

NCT05575830
2022-01314
2023-504482-23
  • Ages 50-95
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 securityscheme

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

Exclusion Criteria:

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

  • Immunosuppression from the following:

  • Current malignant neoplasm;

  • primary immunodeficiency;

  • recent (<2 years) solid or bone-marrow transplant or any transplant stillrequiring immunosuppressive therapy

  • Intake of drugs which suppress the immune system (e.g. glucocorticoids for a longtime [an equivalent dose of prednisolone >20 mg/day > 3 months], monoclonalantibodies, cytostatics, biological products, etc.) within 6 months beforescreening.

  • Administration of immunoglobulins or any blood products within 3 months precedingthe 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 inthe 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 thestudy, e.g. due to language problems, psychological disorders, dementia, etc. of theparticipant

  • Participation in another study with investigational drug within the 30 dayspreceding and during the present study.

  • (France) Pregnant or breastfeeding woman

  • (France) Patient governed by articles L 1121-5 to L 1121-8 (persons deprived oftheir liberty by a judicial or administrative decision, minors, persons of legal agewho are the object of a legal protection measure or unable to express their consent)

Study Design

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: Recombinant Zoster Vaccine
Phase: 4
Study Start date:
December 14, 2022
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • CHU de Bordeaux - Hôpital Haut-Lévèque

    Pessac, Gironde 33604
    France

    Site Not Available

  • Hôpital Saint-André, CHU de Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

  • SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • Kantonsspital

    St Gallen, Saint Gallen 9007
    Switzerland

    Site Not Available

  • Ente Ospedaliero Cantonale

    Lugano, Ticino 6900
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudoise (CHUV)

    Lausanne, Vaud 1011
    Switzerland

    Site Not Available

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • Bern University Hospital (Inselspital)

    Bern, 3010
    Switzerland

    Site Not Available

  • University Hospitals of Geneva

    Geneva, 1205
    Switzerland

    Site Not Available

  • University Hospital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

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