NCT05575830Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 225 (estimated)
- First submitted
- 1 Sept 2022
- Start date
- 14 Dec 2022
- Primary completion date
- 16 Apr 2025
- Lead sponsor
- Calmy Alexandra
- Diseases
- HIV
- NCT number
- NCT05575830
- EU CT number
- 2023-504482-23-00
- EudraCT number
- 2023-504482-23
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 225
- From 14 Dec 2022 to the primary completion date, 16 Apr 2025
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
Other illness
- Ongoing signs of febrile or non-febrile infection at the time of the first vaccination
- 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
Age
- Immunosuppression from the following:
- Current malignant neoplasm;
- primary immunodeficiency;
- recent (\<2 years) solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy
- (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)
Other
- Contra-indication to RZV
- Hospitalized patients
- (France) Pregnant or breastfeeding woman
Who the study is looking for
- 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
Age in the registry: 50 years to 95 years · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Bern University Hospital, Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Hospitals of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| Centre Hospitalier Universitaire Vaudoise (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Ente Ospedaliero Cantonale Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Kantonsspital Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.