Immune response to the recombinant vaccine against shingles in HIV-positive patients over 50 years old compared to an age- and sex-matched control population - a multicenter phase IV study_ Shingr’HIV
Zusammenfassung der Studie
Shingles is caused by the reactivation of the chickenpox virus that remains in the nervous system for life once chickenpox is cured. Shingles presents as pain and a rash and can be complicated by severe and persistent pain (postherpetic neuralgia). The occurrence of shingles and postherpetic neuralgia increases beyond 50 years and in immunocompromised patients, particularly in people living with HIV. • There is a vaccine against shingles, Shingrix®, approved in Switzerland for all individuals over 50 years old as well as for all adults over 18 years old who are severely immunocompromised. • Although studies have shown that Shingrix® is well tolerated and effective in young HIV patients, the vaccine response in older patients who have lived with HIV for a long time is still not well understood, which may make their immune system less effective. Nevertheless, these patients are vulnerable to shingles and are part of the priority groups for vaccination. • The aim of this study is therefore to characterize the immune response and potential side effects of the Shingrix® vaccine in older HIV-positive patients treated with antiretroviral medications. Their response will be compared to that of a control group consisting of individuals over 50 years old and representative of the general population.
(BASEC)
Untersuchte Intervention
Recombinant vaccine against shingles (Shingrix) administered intramuscularly in two doses separated by an interval of two months.
(BASEC)
Untersuchte Krankheit(en)
HIV-positive patients are considered at risk of developing a severe form of shingles due to a weakened immune system.
(BASEC)
HIV patients - participants registered in the Swiss HIV Cohort (SHCS) - over 50 years old - on antiretroviral therapy for more than 10 years - not having received the shingles vaccine - HIV viral load < 50 copies/ml Controls: - over 50 years old - not having received the shingles vaccine (BASEC)
Ausschlusskriterien
- Ongoing signs of febrile or non-febrile infection at the time of the first vaccination. - Immunosuppression due to the following factors: o current malignant neoplasm o primary immunodeficiency; o recent transplantation (<2 years) of solid organs or bone marrow or any transplantation still requiring immunosuppressive treatment o Use of immunosuppressive medications (e.g., long-term glucocorticoids [an equivalent dose of prednisolone > 20 mg/day > 3 months], monoclonal antibodies, cytostatics, biological products, etc.) in the last 2 weeks - Having received a vaccine in the last month or scheduled to receive a vaccine in the next month - Having received a shingles vaccine in the past year - Having had shingles in the past year - Contraindication to RZV - Hospitalized patients - Unable to provide informed consent or to follow the study procedures, for example due to language issues, psychological disorders, dementia, etc. of the participant. - Participation in another study with an experimental drug within 30 days prior to and during this study. (BASEC)
Studienstandort
Basel, Bern, Genf, Lausanne, Lugano, St Gallen, Zürich
(BASEC)
Sponsor
Alexandra Calmy Geneva University Hospital
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Alexandra Calmy
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.chGeneva University Hospital
(BASEC)
Allgemeine Auskünfte
University Hospitals of Geneva, Infectious disease department,,
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.ch(ICTRP)
Allgemeine Auskünfte
University Hospitals of Geneva, Infectious disease department,
(ICTRP)
Wissenschaftliche Auskünfte
University Hospitals of Geneva, Infectious disease department,,
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.10.2022
(BASEC)
ICTRP Studien-ID
NCT05575830 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 - a phase IV multicenter study (BASEC)
Wissenschaftlicher Titel
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 - The Shingr'HIV Phase IV Multicenter Study (ICTRP)
Öffentlicher Titel
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls (ICTRP)
Untersuchte Krankheit(en)
RZV Vaccine (Shingrix ) (ICTRP)
Untersuchte Intervention
Biological: Recombinant Zoster Vaccine (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Geometric mean titer (GMT) of gE-specific total IgG (ICTRP)
Vaccine safety - AESI 7 days;Vaccine safety - SAE 360 days;Vaccine safety -pIMDs;Vaccine safety - PLWH;Vaccine immunogenicity - CD4+ T cells (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Alexandra Calmy, Prof. MD;Alexandra Calmy, Prof. MD, Alexandra.Calmy@hcuge.ch, +41 22 372 98 12, University Hospitals of Geneva, Infectious disease department,, (ICTRP)
Sekundäre IDs
2023-504482-23, 2022-01314 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05575830 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar