2022-01314

About this trial

Last updated 2 years ago

Study ID

2022-01314

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

Accepting

50 to 95 Years

All

Trial Timing

Ended 7 months ago

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.

Inclusion Criteria

- 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 For aged/gender-matched controls

- Age >50 YOA

- Not already vaccinated with RZV

- Informed consent as documented by signature

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.) in the last 14 days.

- 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.