RZV Vaccine (Shingrix ®)Phase 4Shingr'HIVNCT05575830
Immune Response of Shingrix Vaccine in People Living With HIV (> 50 y.o.) Compared to Age-matched Controls
A Phase 4 study testing Recombinant Zoster Vaccine in people with RZV Vaccine (Shingrix ®), run by Calmy Alexandra at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- RZV Vaccine (Shingrix ®)
- What is being tested?
- Recombinant Zoster Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 14 Dec 2022to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Switzerland7 sites
University Hospital Basel
Basel, Basel, 4031
Bern University Hospital (Inselspital)
Bern, Canton of Bern, 3010
University Hospitals of Geneva
Geneva, Canton of Geneva, 1205
Centre Hospitalier Universitaire Vaudoise (CHUV)
Lausanne, Canton of Vaud, 1011
Ente Ospedaliero Cantonale
Lugano, Canton Ticino, 6900
Kantonsspital
Sankt Gallen, Canton of St. Gallen, 9007
University Hospital Zurich
Zurich, Canton of Zurich, 8091
France3 sites
Hôpital Saint-André, CHU de Bordeaux
Bordeaux, Bordeaux, 33075
SMIT - Service de Maladies Infectieuses et Tropicales Le Tripode -Groupe Hospitalier Pellegrin
Bordeaux, France, 33000
CHU de Bordeaux - Hôpital Haut-Lévèque
Pessac, Gironde, 33604
About this study
Official 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
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.
Read the detailed description
This is a prospective multicentric phase IV study, aiming at evaluating the immunogenicity and safety profile of RZV in PLWH over 50 years of age (YOA) on long term antiretroviral therapy (ART) (>10 years) compared to non-HIV age-matched adult controls to address the combined effect of aging and immunosuppression from HIV disease.
Inclusion will be stratified as follow:
HIV+ groups:
- Group 1: PLWH registered in the SHCS or ANRS CO3, >75 YOA and under cART for more than 10 years - N=50
- Group 2: PLWH patients registered in the SHCS, aged between 60 and 75 and under cART for more than 10 years - N=50
- Group 3: PLWH patients registered in the SHCS, aged between 50 and 59 and under cART for more than 10 years - N=50
Control groups:
- Group 4: Healthy adults aged >75 YOA- N=25
- Group 5: Healthy adults aged between 60 and 75 - N=25
- Group 6: Healthy adults aged between 50 and 59 - N=25
In addition, participants of all groups will be proposed to be included in the "Innate substudy" (target of 15 participants/group) and have two additional blood drawings 1 day after each vaccine dose to measure innate response triggered by RZV.
Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 1, Day61, Day90, Day360.
Unsolicited Adverse events of special intesrest (AESI) will be collected on Day 28, Day 60, Day90, Day360; patients reported outcomes (PROs) will be declared for one week after each vaccination.
- Conditions
- RZV Vaccine (Shingrix ®)
- Being tested
- Recombinant Zoster Vaccine
- Keywords
- RZV vaccine, PLWH, Immune response, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Zoster VaccineBiological
Also called (Shingrix® )
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
| Study group | Role | What they receive |
|---|---|---|
| RZV or Shingrix®) | Experimental | Recombinant Zoster Vaccine Receives: Biological: Recombinant Zoster Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of gE-specific total IgG
gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
Measured: Day 90
Secondary outcomes (5)
Vaccine safety - AESI 7 days
Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card
Measured: 7 days
Vaccine safety - SAE 360 days
Incidence of SAE throughout the study period
Measured: 360 days
Vaccine safety -pIMDs
Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Measured: 360 days
Vaccine safety - PLWH
In PLWH: Percentage of PLWH with viral load >50 copies/ml one month after the second RZV vaccination (D90)
Measured: Day 90
Vaccine immunogenicity - CD4+ T cells
Mean of gE-specific CD4+ T cells expressing at least 2 activation markers (i.e. CD40L, IFN-gamma, IL-2 or TNF-alpha) per million of T cells, measured at D90
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start14 Dec 2022
- Primary completion16 Apr 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RZV Vaccine (Shingrix ®)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calmy Alexandra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Calmy Alexandra, University Hospital, Geneva
- Investigators
- Alexandra Calmy, Prof. MD, Study director, University Hospitals of Geneva, Infectious disease department,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575830
- Sponsor's protocol ID
- 2022-01314
- Other IDs
- 2023-504482-23, 2023
- Acronym
- Shingr'HIV
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hentzien M, Bonnet F, Bernasconi E, Biver E, Braun DL, Munting A, Leuzinger K, Leleux O, Musardo S, Prendki V, Schmid P, Staehelin C, Stoeckle M, Walti CS, Wittkop L, Appay V, Didierlaurent AM, Calmy A. Immune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol. BMC Infect Dis. 2024 Mar 19;24(1):329. doi: 10.1186/s12879-024-09192-5.
PubMed 38504173
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05575830
- Acronym / sponsor ID
- Shingr'HIV / 2022-01314
- Conditions
- RZV Vaccine (Shingrix ®)
- Keywords
- RZV vaccine, PLWH, Immune response, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Calmy AlexandraUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective multicentric phase IV study, aiming at evaluating the immunogenicity and safety profile of RZV in PLWH over 50 years of age (YOA) on long term antiretroviral therapy (ART) (>10 years) compared to non-HIV age-matched adult controls to address the combined effect of aging and immunosuppression from HIV disease.
Inclusion will be stratified as follow:
HIV+ groups:
- Group 1: PLWH registered in the SHCS or ANRS CO3, >75 YOA and under cART for more than 10 years - N=50
- Group 2: PLWH patients registered in the SHCS, aged between 60 and 75 and under cART for more than 10 years - N=50
- Group 3: PLWH patients registered in the SHCS, aged between 50 and 59 and under cART for more than 10 years - N=50
Control groups:
- Group 4: Healthy adults aged >75 YOA- N=25
- Group 5: Healthy adults aged between 60 and 75 - N=25
- Group 6: Healthy adults aged between 50 and 59 - N=25
In addition, participants of all groups will be proposed to be included in the "Innate substudy" (target of 15 participants/group) and have two additional blood drawings 1 day after each vaccine dose to measure innate response triggered by RZV.
Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 1, Day61, Day90, Day360.
Unsolicited Adverse events of special intesrest (AESI) will be collected on Day 28, Day 60, Day90, Day360; patients reported outcomes (PROs) will be declared for one week after each vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RZV or Shingrix®) | Experimental | Biological: Recombinant Zoster VaccineRecombinant Zoster Vaccine |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (16 listed)
- Ongoing signs of febrile or non-febrile infection at the time of the first vaccination
- Immunosuppression from the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Zoster VaccineAlso: (Shingrix® )Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60 | Biological | RZV or Shingrix®) |
Primary outcome
Geometric mean titer (GMT) of gE-specific total IgG
Time frame: Day 90
gE-specific total IgG titers is determined by gE-specific ELISA from sera samples
5 secondary outcomes
Vaccine safety - AESI 7 days
Time frame: 7 days
Vaccine safety - SAE 360 days
Time frame: 360 days
Vaccine safety -pIMDs
Time frame: 360 days
Vaccine safety - PLWH
Time frame: Day 90
Vaccine immunogenicity - CD4+ T cells
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 38504173Hentzien M, Bonnet F, Bernasconi E, Biver E, Braun DL, Munting A, Leuzinger K, Leleux O, Musardo S, Prendki V, Schmid P, Staehelin C, Stoeckle M, Walti CS, Wittkop L, Appay V, Didierlaurent AM, Calmy A. Immune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol. BMC Infect Dis. 2024 Mar 19;24(1):329. doi: 10.1186/s12879-024-09192-5.
- Shingrix vaccine informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for RZV Vaccine (Shingrix ®)
Active, not recruitingPhase 4
Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases
Rheumatoid Arthritis, Spondylitis, Ankylosing
RecruitingObservational study
Comprehensive Characterization of Immune Response Induced by Adjuvanted Glycoprotein E (gE)-Based Recombinant VAccine Zoster in Vulnerable Population Receiving ImmunOmodulaNt Therapies
RZV Vaccine (Shingrix ®)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Calmy, Prof. MD study director
University Hospitals of Geneva, Infectious disease department,
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Zoster Vaccine in people with RZV Vaccine (Shingrix ®), run by Calmy Alexandra at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) of gE-specific total IgG (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.