ShinglesPhase 2NCT05554068
Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
A Phase 2 study testing Shingrix in people with Shingles, run by Loyola University at 1 site in United States.
Trial summary
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shingles
- What is being tested?
- Shingrix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥18 years
- ≥ 12 months and ≤ 36 months post-AlloSCT
- Donor sources: matched related, matched unrelated, cord blood
- Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
- Any conditioning regimen
- Any planned immunosuppressive prophylactic regimen
Show all 9Show fewer
- Patients with chronic graft-versus-host disease on stable immunosuppression
- Ability to understand and the willingness to sign a written informed consent.
- Negative pregnancy test in female patients of childbearing potential
Who cannot join
- Patients who had zoster after an allogeneic transplant and prior to enrollment
- Patients who are currently pregnant
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
- Patients who have had a relapse of their primary hematological disease
- Previous allogeneic stem cell transplantation
- Acute disease at the time of vaccination
- Thrombocytopenia that in the judgment of the investigator would make intramuscular injection unsafe.
Trial locations and contacts
1 site in 1 country.
Mary Lee contact
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Patrick Hagen
About this study
Official title: Phase II, Non-randomized, Open-label Study to Assess the Immunogenicity and Clinical Efficacy of the Recombinant Zoster Vaccine for Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Read the detailed description
Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant.
Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.
- Conditions
- Shingles
- Being tested
- Shingrix
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixDrug
Shingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Shingrix | Experimental | Patients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule. Receives: Drug: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell mediated and humoral immune response
Measured: Measured one month following eh last dose of vaccine received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start7 Mar 2023
- Primary completion7 Mar 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShinglesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagen, Patrick A, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554068
- Sponsor's protocol ID
- 215468
- Status last verified
- Mar 2023
- First submitted
- 21 Sep 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Non-randomized, Open-label Study to Assess the Immunogenicity and Clinical Efficacy of the Recombinant Zoster Vaccine for Recipients of an Allogeneic Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05554068
- Acronym / sponsor ID
- 215468
- Conditions
- Shingles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Mar 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Sep 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.
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
Detailed description
Cell mediated immunity is severely compromised after an allogeneic stem cell transplantation. This results in an increased risk of zoster with its associated morbidity and mortality. Patients typically receive prophylactic antivirals for 1 year after AlloSCT which reduces the incidence of zoster during this period. Unfortunately, after completing prophylaxis, patients continue to be at a significantly increased risk of zoster with an incidence rate of up to 29% at 3-years post transplant. The recombinant zoster vaccine provides immunogenicity and has shown clinical efficacy in preventing zoster in patients who have received an autologous transplant.
Furthermore, it has been shown to be safe in patients who had received an allogeneic transplant in a retrospective study although immunogenicity seemed to be decreased in this cohort. Due to the paucity of data in allogeneic recipients, we propose a prospective, non-randomized study to evaluate the immunogenicity and clinical efficacy of the recombinant zoster vaccine in recipients of allogeneic stem cell transplantation. As a secondary endpoint, we will compare our results to historical data of immunogenicity and clinical effectiveness of the vaccine in autologous transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shingrix | Experimental | Drug: ShingrixPatients 1-3 years post transplant will receive the Shingrix vaccine in standard dosing and schedule. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years
- ≥ 12 months and ≤ 36 months post-AlloSCT
- Donor sources: matched related, matched unrelated, cord blood
- Any malignant hematological disease including acute leukemia, myelodysplastic syndrome, non-Hodgkin's lymphoma, Hodgkin's lymphoma, chronic lymphocytic leukemia, chronic myeloid leukemia, multiple myeloma, and myeloproliferative disorders.
- Any conditioning regimen
Key exclusion criteria (7 listed)
- Patients who had zoster after an allogeneic transplant and prior to enrollment
- Patients who are currently pregnant
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the recombinant zoster vaccine, Shingrix, or other agents used in study.
- Patients who have had a relapse of their primary hematological disease
- Previous allogeneic stem cell transplantation
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 |
|---|---|---|
| ShingrixShingrix vaccine will be given to all eligible patients at one to three year post allogeneic stem cell transplantation. | Drug | Shingrix |
Primary outcome
Cell mediated and humoral immune response
Time frame: Measured one month following eh last dose of vaccine received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Mary Lee contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shingrix in people with Shingles, run by Loyola University at 1 site in United States.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick A Hagen (708-327-3810, patrick.hagen@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell mediated and humoral immune response (time frame: Measured one month following eh last dose of vaccine received). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2023.