Varicella Zoster VaccinePhase 3NCT03685682
Recombinant Subunit Herpes Zoster Vaccine in VZV-Seronegative Organ Transplant Recipients
A Phase 3 study testing recombinant subunit Herpes zoster vaccine in people with Varicella Zoster Vaccine, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicella Zoster Vaccine
- What is being tested?
- recombinant subunit Herpes zoster vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2018to 5 Sep 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid organ transplant recipient.
- Age ≥18 years
- VZV-seronegative at time of transplant
- ≥90 days post-transplant
- Able to provide informed consent
Who cannot join
- Has already received the recombinant subunit Herpes zoster vaccine in the past
- Ongoing CMV viremia > 200 IU/mL
- HIV infection
- Diagnosis of malignancy (e.g. PTLD)
- History of a severe allergic reaction (anaphylactic reaction) after any vaccine
- Documented Chickenpox or Shingles after transplantation
Show all 13Show fewer
- Congenital immunodeficiency (e.g., CVID)
- Treatment for rejection in the past 30 days
- Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin
- Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody
- Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis
- Febrile illness in the past one week
- Unable to comply with the study protocol
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
Official title: Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
Read the detailed description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.
- Conditions
- Varicella Zoster Vaccine
- Being tested
- recombinant subunit Herpes zoster vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant subunit Herpes zoster vaccineBiological
Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months
| Study group | Role | What they receive |
|---|---|---|
| VZV seronegative Transplant Patients | Experimental | recombinant subunit Herpes zoster vaccine Receives: Biological: recombinant subunit Herpes zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination
Measured: 4 weeks after second dose of vaccine
Secondary outcomes (1)
Rate of Vaccine-related Adverse Events
Adverse events will be graded as mild, moderate, severe
Measured: Up to 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 posted26 Sep 2018
- Study start25 May 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
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 Varicella Zoster VaccineStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT03685682
- Sponsor's protocol ID
- UHNTID007
- Status last verified
- Aug 2020
- First submitted
- 23 Sep 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
L'Huillier AG, Hirzel C, Ferreira VH, Ierullo M, Ku T, Selzner N, Schiff J, Juvet S, Miao C, Schmid DS, Humar A, Kumar D. Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2316-2323. doi: 10.1097/TP.0000000000003621.
PubMed 33528118
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 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 in VZV-seronegative Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03685682
- Acronym / sponsor ID
- UHNTID007
- Conditions
- Varicella Zoster Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 26 Sep 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 in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
Detailed description
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VZV seronegative Transplant Patients | Experimental | Biological: recombinant subunit Herpes zoster vaccinerecombinant subunit Herpes zoster vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Solid organ transplant recipient.
- Age ≥18 years
- VZV-seronegative at time of transplant
- ≥90 days post-transplant
- Able to provide informed consent
Key exclusion criteria (13 listed)
- Has already received the recombinant subunit Herpes zoster vaccine in the past
- Ongoing CMV viremia > 200 IU/mL
- HIV infection
- Diagnosis of malignancy (e.g. PTLD)
- History of a severe allergic reaction (anaphylactic reaction) after any vaccine
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 subunit Herpes zoster vaccineSeronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months | Biological | VZV seronegative Transplant Patients |
Primary outcome
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
Time frame: 4 weeks after second dose of vaccine
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination
1 secondary outcome
Rate of Vaccine-related Adverse Events
Time frame: Up to 4 weeks after second dose of vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 33528118L'Huillier AG, Hirzel C, Ferreira VH, Ierullo M, Ku T, Selzner N, Schiff J, Juvet S, Miao C, Schmid DS, Humar A, Kumar D. Evaluation of Recombinant Herpes Zoster Vaccine for Primary Immunization of Varicella-seronegative Transplant Recipients. Transplantation. 2021 Oct 1;105(10):2316-2323. doi: 10.1097/TP.0000000000003621.
- 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.
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 3 study testing recombinant subunit Herpes zoster vaccine in people with Varicella Zoster Vaccine, run by University Health Network, Toronto 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 5 Aug 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster 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?
On the ClinicalTrials.gov record for NCT03685682, 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 Aug 2020.