Kidney Transplant Recipient Response to Shingrix VaccinePhase 3NCT04128189
Shingrix in Renal Transplant Recipients
A Phase 3 study testing Shingrix in people with Kidney Transplant Recipient Response to Shingrix Vaccine and Kidney Failure, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant Recipient Response to Shingrix Vaccine, Kidney Failure, Kidney Failure, Chronic
- What is being tested?
- Shingrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Mar 2023to Jun 2029
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years Able and willing to provide written informed consent Currently on the waiting list for kidney transplantation at a participating institution, with anticipated transplantation occurring between >3 and 24 months after the first dose of Shingrix
- Either:
- Eligible to receive Shingrix at study entry per CDC-recommended schedule, or Previously completed the Shingrix vaccination series within 3 to 24 months prior to study entry Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)
- Female participants of childbearing potential must:
- Use adequate contraception for at least 30 days prior to vaccination Have a negative pregnancy test on the day of each vaccination Agree to continue adequate contraception during the study and for 2 months after completing the vaccination series Be considered by the investigator likely to comply with study requirements
Who cannot join
- Active immunosuppressive or immunodeficient condition (e.g., malignancy, HIV infection) or receipt of immunosuppressive therapy within 3 months prior to planned vaccination that, in the investigator's opinion, may interfere with vaccine response History of herpes zoster (shingles) within the past 3 years Receipt of varicella vaccine within 3 years prior to study entry Known allergy to any component of the Shingrix vaccine Receipt of investigational drugs within 30 days prior to enrollment or planned use during the study Receipt of non-live vaccines within 2 weeks prior to any Shingrix dose or planned within 30 days after vaccination Receipt of live vaccines within 4 weeks prior to any Shingrix dose or planned within 30 days after vaccination Pregnant or breastfeeding Planned or prior multi-organ transplantation Residence or travel distance greater than 2 hours from the study site, which would interfere with study visits or timely processing of blood samples
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Varun K Phadke, MD, varun.phadke@emory.edu
Varun K Phadke, MD
- Recruiting
University of Colorado Anschutz
Aurora, Colorado, 80045
Tori Rutherford, RN BSN, 303-724-2454, tori.rutherford@childrenscolorado.org
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Amy C Sherman, MD, acsherman@bwh.harvard.edu
Amy C Sherman, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Hana ElSahly, MD, Hana.ElSahly@bcm.edu
Hana ElSahly, MD
About this study
Official title: Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection.
The main questions it aims to answer are:
Read more
How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant?
Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose?
How long does protection from the vaccine last before and after transplant?
How safe is the vaccine in this group, including whether it affects transplant-related immune markers?
Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection.
Participants will:
Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining
If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose
Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits
Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research
Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.
Read the detailed description
This study is designed to evaluate the immunogenicity and safety of the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) in adults with renal failure, including those who subsequently undergo kidney transplantation. Patients with chronic renal failure and transplant recipients have impaired cellular immunity due to underlying disease and immunosuppressive therapy, placing them at increased risk for herpes zoster and related complications, including post-herpetic neuralgia and disseminated varicella-zoster virus infection. Although Shingrix is recommended for immunocompromised adults, the magnitude, durability, and optimal timing of immune responses in the setting of renal failure and transplantation remain incompletely defined.
The primary objective is to determine whether Shingrix induces acceptable cellular immune responses, as measured by gE-specific T cell activity using FluoroSpot assays, and to evaluate the safety of vaccination in this population. Vaccine response (VR) is defined as a ≥2-fold increase in gE-specific IL-2 FluoroSpot responses compared to baseline, and geometric mean fold rise (GMFR) will be used to quantify the magnitude of immune responses.
Among renal transplant candidates vaccinated at study entry, the study will assess whether ≥60% achieve a vaccine response at 30 days after the second dose and whether the GMFR is at least 60% of that observed in historical immunocompetent controls. In participants who completed the two-dose Shingrix series prior to enrollment, immune response magnitude will be compared with historical controls, adjusted for time since vaccination.
For participants who undergo kidney transplantation, the study will evaluate immune responses before and after transplantation and assess the effect of a third (booster) dose of Shingrix administered post-transplant. Transplant recipients who receive a third dose will be compared with those who do not receive a third dose, with the primary comparison focused on gE-specific cellular immune responses at 1 year after transplantation. Additional comparisons will include responses at ≥2 months post-transplant and 30 days after the third dose, as well as comparisons with non-transplanted participants and historical controls following standard two-dose vaccination.
Safety will be evaluated throughout the study, including assessment of adverse events and monitoring of transplant-related immunologic parameters such as calculated panel-reactive antibodies (cPRA). The study will also assess the overall safety profile of Shingrix administered before and/or after transplantation.
The study is designed to address key gaps in knowledge regarding optimal vaccination strategies in transplant populations. Two approaches are evaluated: vaccination prior to transplantation, when immune competence may be greater, and a combined strategy of pre-transplant vaccination followed by post-transplant boosting. Pre-transplant vaccination may provide early protection during the high-risk post-transplant period and may induce more robust immune memory prior to the initiation of intensive immunosuppression.
Herpes zoster represents a significant clinical and economic burden in transplant recipients, with reported incidence rates of approximately 1.9 cases per 100 patient-years in solid organ transplant populations and substantial associated healthcare costs. Optimizing the use of Shingrix in this population has the potential to reduce morbidity and improve outcomes in patients with renal failure and those undergoing transplantation.
Immunologic outcomes will include measurement of both humoral and cellular immune responses, including gE-specific antibody levels and T cell responses. Cellular immunity will be assessed using validated FluoroSpot assays measuring IL-2-producing cells, with additional exploratory analyses of T cell subsets (including central memory, effector memory, follicular helper, and stem cell memory T cells) to better characterize immune durability and function. Peripheral blood mononuclear cells will be processed and analyzed using standardized procedures to ensure reproducibility and comparability with historical datasets.
Overall, this study will define the magnitude and durability of immune responses to Shingrix in patients with renal failure, determine the impact of kidney transplantation on vaccine-induced immunity, and evaluate whether a third dose administered after transplantation enhances immune protection. These findings are expected to inform vaccination strategies for transplant candidates and recipients and address an important unmet need in immunocompromised populations.
- Conditions
- Kidney Transplant Recipient Response to Shingrix Vaccine, Kidney Failure, Kidney Failure, Chronic, Kidney Transplantation, Herpes Zoster (HZ)
- Being tested
- Shingrix
- Keywords
- Shingrix, Recombinant Zoster Vaccine, Herpes Zoster Vaccine, Herpes Zoster, Shingles, Kidney Failure, Chronic Kidney Disease, Renal Failure, Kidney Transplant, Renal Transplantation, Transplant Candidates, Immunocompromised, Immunogenicity, Vaccine Response, Cellular Immunity, T Cell Response, Booster Dose, Vaccine Durability, Post-Transplant Immunity, Vaccine Safety
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Herpes Zoster, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShingrixBiological
Intervention: Biological - Recombinant Zoster Vaccine (Shingrix) The recombinant adjuvanted glycoprotein E (gE) herpes zoster vaccine (Shingrix) will be administered as a 0.5 mL intramuscular injection per dose. Participants who have not previously received Shingrix will receive the standard two-dose series, with doses administered at Month 0 and Month 2. Participants who have previously completed the primary two-dose series will not receive additional doses at study entry.
Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive either a third (booster) dose of Shingrix or no additional dose. The third dose, when administered, will consist of a single 0.5 mL intramuscular injection given at least 2 months following transplantation, when clinically stable.
The duration of participation for vaccination and follow-up is approximately 30 to 37 months. Immunogenicity and safety outcomes will be assessed at multiple time points
| Study group | Role | What they receive |
|---|---|---|
| Transplanted subject | Experimental | Experimental Arm: Third Dose of Shingrix (Post-Transplant) Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive a third (booster) dose of the recombinant zoster vaccine (Shingrix) after transplantation. These participants will be followed to assess immunogenicity (e.g., vaccine response and geometric mean fold rise) and safety outcomes over time. Receives: Biological: Shingrix |
| No Intervention Comparator Arm: No Third Dose (Post-Transplant) | No intervention | Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive no additional (third) dose of Shingrix after transplantation. These participants will undergo the same follow-up assessments to evaluate immunogenicity and safety outcomes and will serve as the comparator group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gE-Specific IL-2 T Cell Response at 12 Months After Randomization
- gE-Specific IL-2 T Cell Response at 12 Months After Randomization
Description: Cellular immune response measured by gE-specific IL-2-producing spot-forming cells (SFC) per 10⁶ peripheral blood mononuclear cells (PBMC) using FluoroSpot assay in renal transplant recipients. Comparison between participants who receive a third dose of Shingrix post-transplant and those who do not receive a third dose.
Time frame: 12 months after vaccination (post-transplant)
Measured: 12 months after vaccination
Secondary outcomes (6)
Vaccine Response (VR) at 30 Days After Second Dose
Description: Proportion of participants achieving a ≥2-fold increase in gE-specific IL-2 FluoroSpot responses compared to pre-vaccination baseline among transplant candidates vaccinated at study entry.
Measured: Time Frame: 30 days after second dose (approximately Month 3)
Geometric Mean Fold Rise (GMFR) in gE-Specific IL-2 Responses at 30 Days After Second Dose
Description: Fold increase in gE-specific IL-2 FluoroSpot responses from baseline in transplant candidates vaccinated at study entry, compared with historical controls.
Measured: Time Frame: 30 days after second dose
GMFR in Previously Vaccinated Participants
Description: Magnitude of gE-specific IL-2 FluoroSpot responses in participants who completed the two-dose Shingrix series prior to enrollment, compared with historical controls adjusted for time since vaccination.
Measured: Time Frame: Study entry, 24 months, and 36 months after vaccination
Immunogenicity at ≥2 Months Post-Transplant
Description: GMFR in gE-specific IL-2 FluoroSpot responses in transplant recipients at least 2 months after transplantation, compared with historical controls and non-transplanted participants.
Measured: Time Frame: ≥2 months post-transplant
Immune Response 30 Days After Third Dose (Post-Transplant)
VR and GMFR in transplant recipients 30 days after receipt of a third dose of Shingrix, compared with historical controls (after two doses) and non-transplanted participants.
Measured: 30 days after third dose
GMFR at 1 Year Post-Randomization
Comparison of GMFR in transplant recipients who receive a third dose versus those who do not, and versus historical controls after two-dose vaccination.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start2 Mar 2023
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Recipient Response to Shingrix VaccineStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel assignment design. All enrolled participants will undergo evaluation of immune responses to the recombinant zoster vaccine (Shingrix), including those vaccinated at study entry and those previously vaccinated prior to enrollment. Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized in a 1:1 ratio to one of two parallel groups: (1) receipt of a third (booster) dose of Shingrix administered post-transplant, or (2) no additional (third) dose following transplantation. The two groups will be followed concurrently and compared with respect to immunogenicity outcomes, including vaccine response (VR) and geometric mean fold rise (GMFR), as well as safety outcomes. Randomization will occur after transplantation, and participants will remain in their assigned group for the duration of follow-up. Participants who do not undergo transplantation will not be randomized but will contribute observational immunogenic
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Myron J Levin, MD, Principal investigator, University of Colorado Anschutz School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128189
- Sponsor's protocol ID
- 19-0005
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Shingrix in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT04128189
- Acronym / sponsor ID
- 19-0005
- Conditions
- Kidney Transplant Recipient Response to Shingrix Vaccine, Kidney Failure, Kidney Failure, Chronic, Kidney Transplantation, Herpes Zoster (HZ)
- Keywords
- Shingrix, Recombinant Zoster Vaccine, Herpes Zoster Vaccine, Herpes Zoster, Shingles, Kidney Failure, Chronic Kidney Disease, Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 Oct 2019 (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 goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection.
The main questions it aims to answer are:
How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant?
Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose?
How long does protection from the vaccine last before and after transplant?
How safe is the vaccine in this group, including whether it affects transplant-related immune markers?
Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection.
Participants will:
Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining
If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose
Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits
Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research
Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.
Detailed description
This study is designed to evaluate the immunogenicity and safety of the adjuvanted recombinant glycoprotein E (gE) herpes zoster (HZ) vaccine (Shingrix) in adults with renal failure, including those who subsequently undergo kidney transplantation. Patients with chronic renal failure and transplant recipients have impaired cellular immunity due to underlying disease and immunosuppressive therapy, placing them at increased risk for herpes zoster and related complications, including post-herpetic neuralgia and disseminated varicella-zoster virus infection. Although Shingrix is recommended for immunocompromised adults, the magnitude, durability, and optimal timing of immune responses in the setting of renal failure and transplantation remain incompletely defined.
The primary objective is to determine whether Shingrix induces acceptable cellular immune responses, as measured by gE-specific T cell activity using FluoroSpot assays, and to evaluate the safety of vaccination in this population. Vaccine response (VR) is defined as a ≥2-fold increase in gE-specific IL-2 FluoroSpot responses compared to baseline, and geometric mean fold rise (GMFR) will be used to quantify the magnitude of immune responses.
Among renal transplant candidates vaccinated at study entry, the study will assess whether ≥60% achieve a vaccine response at 30 days after the second dose and whether the GMFR is at least 60% of that observed in historical immunocompetent controls. In participants who completed the two-dose Shingrix series prior to enrollment, immune response magnitude will be compared with historical controls, adjusted for time since vaccination.
For participants who undergo kidney transplantation, the study will evaluate immune responses before and after transplantation and assess the effect of a third (booster) dose of Shingrix administered post-transplant. Transplant recipients who receive a third dose will be compared with those who do not receive a third dose, with the primary comparison focused on gE-specific cellular immune responses at 1 year after transplantation. Additional comparisons will include responses at ≥2 months post-transplant and 30 days after the third dose, as well as comparisons with non-transplanted participants and historical controls following standard two-dose vaccination.
Safety will be evaluated throughout the study, including assessment of adverse events and monitoring of transplant-related immunologic parameters such as calculated panel-reactive antibodies (cPRA). The study will also assess the overall safety profile of Shingrix administered before and/or after transplantation.
The study is designed to address key gaps in knowledge regarding optimal vaccination strategies in transplant populations. Two approaches are evaluated: vaccination prior to transplantation, when immune competence may be greater, and a combined strategy of pre-transplant vaccination followed by post-transplant boosting. Pre-transplant vaccination may provide early protection during the high-risk post-transplant period and may induce more robust immune memory prior to the initiation of intensive immunosuppression.
Herpes zoster represents a significant clinical and economic burden in transplant recipients, with reported incidence rates of approximately 1.9 cases per 100 patient-years in solid organ transplant populations and substantial associated healthcare costs. Optimizing the use of Shingrix in this population has the potential to reduce morbidity and improve outcomes in patients with renal failure and those undergoing transplantation.
Immunologic outcomes will include measurement of both humoral and cellular immune responses, including gE-specific antibody levels and T cell responses. Cellular immunity will be assessed using validated FluoroSpot assays measuring IL-2-producing cells, with additional exploratory analyses of T cell subsets (including central memory, effector memory, follicular helper, and stem cell memory T cells) to better characterize immune durability and function. Peripheral blood mononuclear cells will be processed and analyzed using standardized procedures to ensure reproducibility and comparability with historical datasets.
Overall, this study will define the magnitude and durability of immune responses to Shingrix in patients with renal failure, determine the impact of kidney transplantation on vaccine-induced immunity, and evaluate whether a third dose administered after transplantation enhances immune protection. These findings are expected to inform vaccination strategies for transplant candidates and recipients and address an important unmet need in immunocompromised populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel assignment design. All enrolled participants will undergo evaluation of immune responses to the recombinant zoster vaccine (Shingrix), including those vaccinated at study entry and those previously vaccinated prior to enrollment. Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized in a 1:1 ratio to one of two parallel groups: (1) receipt of a third (booster) dose of Shingrix administered post-transplant, or (2) no additional (third) dose following transplantation. The two groups will be followed concurrently and compared with respect to immunogenicity outcomes, including vaccine response (VR) and geometric mean fold rise (GMFR), as well as safety outcomes. Randomization will occur after transplantation, and participants will remain in their assigned group for the duration of follow-up. Participants who do not undergo transplantation will not be randomized but will contribute observational immunogenic
| Arm | Type | Receives |
|---|---|---|
| Transplanted subject | Experimental | Biological: ShingrixExperimental Arm: Third Dose of Shingrix (Post-Transplant) Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive a third (booster) dose of the recombinant zoster vaccine (Shingrix) after transplantation. These participants will be followed to assess immunogenicity (e.g., vaccine response and geometric mean fold rise) and safety outcomes over time. |
| No Intervention Comparator Arm: No Third Dose (Post-Transplant) | No intervention | –Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive no additional (third) dose of Shingrix after transplantation. These participants will undergo the same follow-up assessments to evaluate immunogenicity and safety outcomes and will serve as the comparator group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 70 years Able and willing to provide written informed consent Currently on the waiting list for kidney transplantation at a participating institution, with anticipated transplantation occurring between >3 and 24 months after the first dose of Shingrix
- Eligible to receive Shingrix at study entry per CDC-recommended schedule, or Previously completed the Shingrix vaccination series within 3 to 24 months prior to study entry Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)
- Use adequate contraception for at least 30 days prior to vaccination Have a negative pregnancy test on the day of each vaccination Agree to continue adequate contraception during the study and for 2 months after completing the vaccination series Be considered by the investigator likely to comply with study requirements
Key exclusion criteria (1 listed)
- Active immunosuppressive or immunodeficient condition (e.g., malignancy, HIV infection) or receipt of immunosuppressive therapy within 3 months prior to planned vaccination that, in the investigator's opinion, may interfere with vaccine response History of herpes zoster (shingles) within the past 3 years Receipt of varicella vaccine within 3 years prior to study entry Known allergy to any component of the Shingrix vaccine Receipt of investigational drugs within 30 days prior to enrollment or planned use during the study Receipt of non-live vaccines within 2 weeks prior to any Shingrix dose or planned within 30 days after vaccination Receipt of live vaccines within 4 weeks prior to any Shingrix dose or planned within 30 days after vaccination Pregnant or breastfeeding Planned or prior multi-organ transplantation Residence or travel distance greater than 2 hours from the study site, which would interfere with study visits or timely processing of blood samples
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 |
|---|---|---|
| ShingrixIntervention: Biological - Recombinant Zoster Vaccine (Shingrix) The recombinant adjuvanted glycoprotein E (gE) herpes zoster vaccine (Shingrix) will be administered as a 0.5 mL intramuscular injection per dose. Participants who have not previously received Shingrix will receive the standard two-dose series, with doses administered at Month 0 and Month 2. Participants who have previously completed the primary two-dose series will not receive additional doses at study entry. Participants who undergo kidney transplantation within 24 months after initial vaccination will be randomized to receive either a third (booster) dose of Shingrix or no additional dose. The third dose, when administered, will consist of a single 0.5 mL intramuscular injection given at least 2 months following transplantation, when clinically stable. The duration of participation for vaccination and follow-up is approximately 30 to 37 months. Immunogenicity and safety outcomes will be assessed at multiple time points | Biological | Transplanted subject |
Primary outcome
gE-Specific IL-2 T Cell Response at 12 Months After Randomization
Time frame: 12 months after vaccination
1. gE-Specific IL-2 T Cell Response at 12 Months After Randomization Description: Cellular immune response measured by gE-specific IL-2-producing spot-forming cells (SFC) per 10⁶ peripheral blood mononuclear cells (PBMC) using FluoroSpot assay in renal transplant recipients. Comparison between participants who receive a third dose of Shingrix post-transplant and those who do not receive a third dose. Time frame: 12 months after vaccination (post-transplant)
6 secondary outcomes
Vaccine Response (VR) at 30 Days After Second Dose
Time frame: Time Frame: 30 days after second dose (approximately Month 3)
Geometric Mean Fold Rise (GMFR) in gE-Specific IL-2 Responses at 30 Days After Second Dose
Time frame: Time Frame: 30 days after second dose
GMFR in Previously Vaccinated Participants
Time frame: Time Frame: Study entry, 24 months, and 36 months after vaccination
Immunogenicity at ≥2 Months Post-Transplant
Time frame: Time Frame: ≥2 months post-transplant
Immune Response 30 Days After Third Dose (Post-Transplant)
Time frame: 30 days after third dose
GMFR at 1 Year Post-Randomization
Time frame: 12 months after randomization
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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.
Myron J Levin, MD principal investigator
University of Colorado Anschutz School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shingrix in people with Kidney Transplant Recipient Response to Shingrix Vaccine and Kidney Failure, run by University of Colorado, Denver at 4 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 1 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
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?
Contact Tori Rutherford, RN BSN (303-724-2454, tori.rutherford@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gE-Specific IL-2 T Cell Response at 12 Months After Randomization (time frame: 12 months after vaccination). 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 Apr 2026.