Shingrix Vaccine for Kidney Transplant Recipients
Trial Summary
What is the purpose of this trial?
This study evaluates the safety and immune response of the Shingrix vaccine in kidney transplant recipients. Participants on the waiting list for kidney transplant will be given the standard 2 doses of Shingrix. Those participants who have been transplanted by 16 months, may be given a 3rd dose of Shingrix.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take investigational drugs 30 days before or during the study, and you should avoid certain vaccines close to the time you receive Shingrix.
What data supports the effectiveness of the Shingrix vaccine for kidney transplant recipients?
Research shows that the Shingrix vaccine significantly boosts the immune response against the varicella-zoster virus in kidney transplant recipients, with a median response 8 times higher after the second dose compared to before vaccination. This suggests that the vaccine can effectively enhance immunity in these patients, despite their immunocompromised status.12345
Is the Shingrix vaccine safe for kidney transplant recipients?
The Shingrix vaccine has been shown to be generally safe in humans, with most people experiencing mild reactions like pain at the injection site or fever. Serious side effects are rare and occur at similar rates as in those who received a placebo. However, there was a case of a blistering skin reaction in a patient with a different condition, which is not common.13567
How is the Shingrix vaccine unique for kidney transplant recipients?
Shingrix is a unique vaccine for kidney transplant recipients because it is a recombinant vaccine that contains a specific protein from the varicella-zoster virus and an adjuvant to boost the immune response, making it effective even in those with weakened immune systems due to immunosuppressive therapy.12348
Research Team
Myron J Levin, MD
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
This trial is for adults on the kidney transplant waiting list, expected to receive a transplant within 3-16 months. Women must use contraception and have a negative pregnancy test before vaccination. Excluded are those with recent herpes vaccines, positive cPRA scores, other vaccine or drug conflicts, travel constraints, immune suppression not related to transplantation, multi-organ transplants or acute illness.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the standard 2 doses of Shingrix, with a potential 3rd dose for those transplanted by 16 months
Follow-up
Participants are monitored for safety, tolerability, and immune response, including SAEs, pIMDs, and occurrence of HZ
Treatment Details
Interventions
- Shingrix
Shingrix is already approved in United States, European Union, Canada for the following indications:
- Prevention of shingles in healthy adults over age 50 and in immunocompromised adults over age 18
- Prevention of herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults 50 years of age and older
- Prevention of herpes zoster (shingles) in adults 50 years of age and older
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor