Active, not recruiting
Phase 4
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
Condition(s) studied
RZV Vaccine (Shingrix ®)
Investigational drug(s) / intervention(s)
Recombinant Zoster Vaccine: Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
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
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)
Primary outcome measure(s)
- Geometric mean titer (GMT) of gE-specific total IgG — Day 90
gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
Trial sites (10)
| Facility | City | Region | Status |
| Hôpital Saint-André, CHU de Bordeaux |
Bordeaux |
Bordeaux |
|
| SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin |
Bordeaux |
France |
|
| CHU de Bordeaux - Hôpital Haut-Lévèque |
Pessac |
Gironde |
|
| University Hospital Basel |
Basel |
Basel |
|
| Bern University Hospital (Inselspital) |
Bern |
Canton of Bern |
|
| University Hospitals of Geneva |
Geneva |
Canton of Geneva |
|
| Kantonsspital |
Sankt Gallen |
Canton of St. Gallen |
|
| Centre Hospitalier Universitaire Vaudoise (CHUV) |
Lausanne |
Canton of Vaud |
|
| University Hospital Zurich |
Zurich |
Canton of Zurich |
|
| Ente Ospedaliero Cantonale |
Lugano |
Canton Ticino |
|