Varicella Zoster VaccinePhase 4NCT03493776
Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
A Phase 4 study testing VZV subunit vaccine in people with Varicella Zoster Vaccine, run by Deepali Kumar at 1 site in Canada.
Trial summary
The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Varicella Zoster Vaccine
- What is being tested?
- VZV subunit vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2018to Apr 2021
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single or double lung transplant recipient.
- Age ≥50 years
- On waiting list for lung transplantation
- Age ≥50 years
Who cannot join
- Has already received varicella zoster subunit vaccine in the past
- Shingles within the last 12 months
- Ongoing CMV viremia > 200 IU/mL
- HIV infection
- Diagnosis of malignancy (eg PTLD)
- Has already received Shingrix or Zostavax (live shingles vaccine) in the past
Show all 10Show fewer
- Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
- Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
- Shingles within the last 12 months
- HIV infection
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Toronto General Hospital, Multi-Organ Transplant
Toronto, Ontario, M5G2N2
About this study
The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
Read the detailed description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
- Conditions
- Varicella Zoster Vaccine
- Being tested
- VZV subunit vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VZV subunit vaccineBiological
VZV subunit vaccine
| Study group | Role | What they receive |
|---|---|---|
| Pre-Transplant Group | Active comparator | VZV Subunit vaccine will be administered Receives: Biological: VZV subunit vaccine |
| Post-Transplant Group | Experimental | VZV Subunit vaccine will be administered Receives: Biological: VZV subunit vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination).
Measured: 4 weeks after second dose of vaccine
Secondary outcomes (2)
Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.
Humoral immunogenicity (increase of GMTs of anti-VZV antibodies) in lung transplant
Measured: 4 weeks after second dose of vaccine
Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group
Humoral immunogenicity (GMTs of anti-VZV antibodies compared pre and post vaccination) against VZV induced by varicella zoster subunit vaccine in lung transplant recipients compared to the pre-transplant control group.
Measured: 4 weeks after second dose of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 Apr 2018
- Primary completion5 Sep 2019
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella Zoster VaccineStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepali Kumar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deepali Kumar, University Health Network, Toronto
- Investigators
- Deepali Kumar, MD, Principal investigator, Multi organ transplant program, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493776
- Sponsor's protocol ID
- UHN-Shingrix-001
- Status last verified
- Oct 2020
- First submitted
- 29 Mar 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
- ClinicalTrials.gov ID
- NCT03493776
- Acronym / sponsor ID
- UHN-Shingrix-001
- Conditions
- Varicella Zoster Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Deepali KumarUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 Apr 2018 (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 investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
Detailed description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Transplant Group | Active comparator | Biological: VZV subunit vaccineVZV Subunit vaccine will be administered |
| Post-Transplant Group | Experimental | Biological: VZV subunit vaccineVZV Subunit vaccine will be administered |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single or double lung transplant recipient.
- Age ≥50 years
- On waiting list for lung transplantation
- Age ≥50 years
Key exclusion criteria (10 listed)
- Has already received varicella zoster subunit vaccine in the past
- Shingles within the last 12 months
- Ongoing CMV viremia > 200 IU/mL
- HIV infection
- Diagnosis of malignancy (eg PTLD)
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 |
|---|---|---|
| VZV subunit vaccineVZV subunit vaccine | Biological | Post-Transplant Group, Pre-Transplant Group |
Primary outcome
Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
Time frame: 4 weeks after second dose of vaccine
Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination).
2 secondary outcomes
Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.
Time frame: 4 weeks after second dose of vaccine
Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group
Time frame: 4 weeks after second dose of vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Varicella Zoster Vaccine
RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
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.
Deepali Kumar, MD principal investigator
Multi organ transplant program, University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VZV subunit vaccine in people with Varicella Zoster Vaccine, run by Deepali Kumar at 1 site in Canada.
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 4 inclusion and 10 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 19 Oct 2020. 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 Canada. 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?
Results are not available in the source record.
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?
Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine. (time frame: 4 weeks after second dose of vaccine). 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 19 Oct 2020.