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
Summary description of the study
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)
Intervention under investigation
Recombinant vaccine against shingles (Shingrix) administered intramuscularly in two doses separated by an interval of two months.
(BASEC)
Disease under investigation
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)
Exclusion criteria
- 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)
Trial sites
Basel, Bern, Geneva, Lausanne, Lugano, St. Gallen, Zurich
(BASEC)
Sponsor
Alexandra Calmy Geneva University Hospital
(BASEC)
Contact
Contact Person Switzerland
Alexandra Calmy
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.chGeneva University Hospital
(BASEC)
General Information
University Hospitals of Geneva, Infectious disease department,,
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.ch(ICTRP)
General Information
University Hospitals of Geneva, Infectious disease department,
(ICTRP)
Scientific Information
University Hospitals of Geneva, Infectious disease department,,
+41 22 372 98 12
Alexandra.Calmy@clutterhcuge.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
20.10.2022
(BASEC)
ICTRP Trial ID
NCT05575830 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls (ICTRP)
Disease under investigation
RZV Vaccine (Shingrix ) (ICTRP)
Intervention under investigation
Biological: Recombinant Zoster Vaccine (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
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)
Secondary trial IDs
2023-504482-23, 2022-01314 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05575830 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available