Phase
Condition
N/ATreatment
Recombinant Zoster Vaccine
Clinical Study ID
Ages 50-95 All Genders Accepts Healthy Volunteers
Study Summary
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
Study Description
Connect with a study center
CHU de Bordeaux - Hôpital Haut-Lévèque
Pessac, Gironde 33604
FranceSite Not Available
Hôpital Saint-André, CHU de Bordeaux
Bordeaux, 33075
FranceSite Not Available
SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
Bordeaux, 33000
FranceSite Not Available
Kantonsspital
St Gallen, Saint Gallen 9007
SwitzerlandSite Not Available
Ente Ospedaliero Cantonale
Lugano, Ticino 6900
SwitzerlandSite Not Available
Centre Hospitalier Universitaire Vaudoise (CHUV)
Lausanne, Vaud 1011
SwitzerlandSite Not Available
University Hospital Basel
Basel, 4031
SwitzerlandSite Not Available
Bern University Hospital (Inselspital)
Bern, 3010
SwitzerlandSite Not Available
University Hospitals of Geneva
Geneva, 1205
SwitzerlandSite Not Available
University Hospital Zurich
Zurich, 8091
SwitzerlandSite Not Available
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