Varicella ZosterPhase 4NCT06162494
Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
A Phase 4 study testing Recombinant Zoster Vaccine in people with Varicella Zoster, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites in United States.
Trial summary
This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity. Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Varicella Zoster
- 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
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Mar 2024to 30 Sep 2028
- 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 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 19 years of age or older and willing to provide written informed consent for the study participation.
- Prior recipient of solid organ transplant more than one year prior to participation.
- Stable immunosuppressive medication regimen for last 6 months prior to participation
- Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
- For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.
Who cannot join
- Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
- More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
- History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
- Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
- History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
- Active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine
- Febrile illness with Temp ≥39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1.
- Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
Read the detailed description
This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.
- Conditions
- Varicella Zoster
- Being tested
- Recombinant Zoster Vaccine
- Keywords
- Solid Organ Transplant, Vaccine
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
After giving consent, participants will be given first dose of vaccine. Participants will be brought back 60-90 days post-vaccine for follow up testing and second dose of vaccine
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Zoster Vaccine Administration and Testing | Experimental | all participants will receive 2 doses of recombinant zoster vaccine (Shingrix) Receives: Biological: Recombinant Zoster Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Reporting
Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories
- Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2)
- Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2)
- Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2)
- Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study
Measured: 30 days-1 year
Anti-glycoprotein E antibody Concentration
Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration
Measured: 30-60 days
Secondary outcomes (2)
Glycoprotein E-Specific Cellular Responses
Percentage of vaccinees with 2-fold rise in glycoprotein E-specific cellular responses as defined by interferon and IL-2 measured by Fluorospot
Measured: 30-60 days
Acute Rejection Reporting
Percentage of vaccinees that develop complications of acute rejection within 2 months of receiving each dose of the 2-dose series compared to historical time since transplant-graft- and immunosuppressive regimen-matched unvaccinated controls
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start18 Mar 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella ZosterStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Ravi Jhaveri, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Ravi Jhaveri, MD, Principal investigator, Ann and Robert H Lurie Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162494
- Sponsor's protocol ID
- 2022-5099
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2023
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT06162494
- Acronym / sponsor ID
- 2022-5099
- Conditions
- Varicella Zoster
- Keywords
- Solid Organ Transplant, Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, Children's Hospital Medical Center, Cincinnati
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 8 Dec 2023 (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 goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
Detailed description
This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant Zoster Vaccine Administration and Testing | Experimental | Biological: Recombinant Zoster Vaccineall participants will receive 2 doses of recombinant zoster vaccine (Shingrix) |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 19 years of age or older and willing to provide written informed consent for the study participation.
- Prior recipient of solid organ transplant more than one year prior to participation.
- Stable immunosuppressive medication regimen for last 6 months prior to participation
- Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
- For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.
Key exclusion criteria (8 listed)
- Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
- More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
- History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
- Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
- History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
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: ShingrixAfter giving consent, participants will be given first dose of vaccine. Participants will be brought back 60-90 days post-vaccine for follow up testing and second dose of vaccine | Biological | Recombinant Zoster Vaccine Administration and Testing |
Primary outcome
Adverse Event Reporting
Time frame: 30 days-1 year
Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories 1. Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2) 2. Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2) 3. Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2) 4. Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study
Anti-glycoprotein E antibody Concentration
Time frame: 30-60 days
Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration
2 secondary outcomes
Glycoprotein E-Specific Cellular Responses
Time frame: 30-60 days
Acute Rejection Reporting
Time frame: 2 months
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 27 Mar 2026.
- 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.
Ravi Jhaveri, MD principal investigator
Ann and Robert H Lurie Children's Hospital
3 sites in 1 country: 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 Varicella Zoster, run by Ann & Robert H Lurie Children's Hospital of Chicago at 3 sites 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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Adverse Event Reporting (time frame: 30 days-1 year). The study lists 2 primary outcomes in all. 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 27 Mar 2026.