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

NCT ID: NCT05575830

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2026-03-31

Brief 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 ®)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RZV or Shingrix®)

Recombinant Zoster Vaccine

Group Type: EXPERIMENTAL

Recombinant Zoster Vaccine

Intervention Type: BIOLOGICAL

Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Interventions

Recombinant Zoster Vaccine

Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Intervention Type: BIOLOGICAL

Other Intervention Names

(Shingrix® )

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Calmy Alexandra

OTHER

Sponsor Role: lead

Responsible Party

Calmy Alexandra

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexandra Calmy, Prof. MD

Role: STUDY_DIRECTOR

University Hospitals of Geneva, Infectious disease department,

Locations

Hôpital Saint-André, CHU de Bordeaux

Bordeaux, Bordeaux, France

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

Bordeaux, France, France

CHU de Bordeaux - Hôpital Haut-Lévèque

Pessac, Gironde, France

University Hospital Basel

Basel, Basel, Switzerland

Bern University Hospital (Inselspital)

Bern, Canton of Bern, Switzerland

University Hospitals of Geneva

Geneva, Canton of Geneva, Switzerland

Kantonsspital

Sankt Gallen, Canton of St. Gallen, Switzerland

Centre Hospitalier Universitaire Vaudoise (CHUV)

Lausanne, Canton of Vaud, Switzerland

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Ente Ospedaliero Cantonale

Lugano, Canton Ticino, Switzerland

Countries

France; Switzerland

References

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.

Reference Type: DERIVED

PMID: 38504173 (View on PubMed)

Related Links

https://www.ema.europa.eu/documents/product-information/shingrix-epar-product-information_en.pdf

Shingrix vaccine information

Other Identifiers

2023-504482-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-01314

Identifier Type: -

Identifier Source: org_study_id