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

Active Not RecruitingPhase 4

Sponsor: Calmy Alexandra

Conditions: RZV Vaccine (Shingrix ®)

Interventions: Recombinant Zoster Vaccine

Countries: France, Switzerland

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 overview

Sex: ALL

Age: 50 Years to 95 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)

Locations (10)

Bordeaux, Bordeaux, France
Bordeaux, France, France
Pessac, Gironde, France
Basel, Basel, Switzerland
Bern, Canton of Bern, Switzerland
Geneva, Canton of Geneva, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Lausanne, Canton of Vaud, Switzerland
Zurich, Canton of Zurich, Switzerland
Lugano, Canton Ticino, Switzerland