Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched… (NCT05575830) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
France, Switzerland225 participantsStarted 2022-12-14
Plain-language 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.
Who can participate
Age range50 Years – 95 Years
SexALL
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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 …
What they're measuring
1
Geometric mean titer (GMT) of gE-specific total IgG