BridgeMD
Immune response to the recombinant Zoster Vaccine in people living with HIV over 50 years of age compared to non-HIV age- and gender-matched controls - Shingr'HIV
EU CTIS ID: 2023-504482-23-00
What this study is testing
To assess the antibody response to RZV at D90 in >50 YOA PLWH under cART for more than 10 years compared to age/gender-matched non-HIV controls.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- For PLWH: Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort
- For PLWH + Controls : Age >50 YOA
- For PLWH: Time since cART initiation > 10 years
- For PLWH + Controls : Not already vaccinated with RZV
- For PLWH: HIV viral load <50 copies/ml (within 6 months from the last blood sampling)
- For PLWH + Controls : Informed consent as documented by signature
You likely can't join if
- Ongoing signs of febrile or non-febrile infection at the time of the first vaccination
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period
- (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).
- 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 prednisone >20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening
- Having received a vaccine in the last month or is expected to receive a vaccine in the next month
See the full eligibility criteria
- For PLWH: Be registered in the SHCS or in the ANRS CO3 Aquitaine Cohort
- For PLWH + Controls : Age >50 YOA
- For PLWH: Time since cART initiation > 10 years
- For PLWH + Controls : Not already vaccinated with RZV
- For PLWH: HIV viral load <50 copies/ml (within 6 months from the last blood sampling)
- For PLWH + Controls : Informed consent as documented by signature
- For PLWH + Controls : (France) : Person affiliated with or beneficiary of the French social security scheme
- Ongoing signs of febrile or non-febrile infection at the time of the first vaccination
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Administration of immunoglobulins or any blood products within 3 months preceding the first dose of vaccine or planned administration during the study period
- (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).
- 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 prednisone >20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) within 6 months before screening
- 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 due to hypersensitivity to the active substances or to any of the excipients
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.