Solid Organ Transplant SHINGRIX (NCT03993717) | Clinical Trial Compass
TerminatedNot Applicable
Solid Organ Transplant SHINGRIX
Stopped: Due to personnel changes and COVID-19.
United States2 participantsStarted 2020-01-30
Plain-language summary
This study will assess the immune responses to the recombinant, AS01-adjuvanted varicella zoster virus subunit (HZ/su) vaccine or SHINGRIX in immunosuppressed patients, particularly those who have received a renal transplant, and aim to better understand if the vaccine and perhaps other adjuvanted vaccines are safe in these patients.
30 participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.The duration of the study is 180 days.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Capable of informed consent and provision of written informed consent before any study procedures.
. Capable of attending study visits according to the study schedule
. Males or females greater than or equal to 50 years of age.
. Oral temperature less than 38 C.
. Are in general good health, as determined by medical history and targeted physical exam related to this history
. Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in levels of Anti-gE antibody concentrations
Timeframe: Day 1, Day 61, Day 180
2
Change in number of subjects with a vaccine response for anti-gE antibody
. Have received an ABO compatible allogeneic renal transplant
Exclusion criteria
. Have received any transplant in addition to renal transplant
. Have an acute illness within 72 hours prior to vaccination
. Have a severe medical condition as determined by the investigators
. Have kidney disease related to any known immune/autoimmune phenomena including, but not limited to: systemic lupus erythematosus, glomerulonephritis (post-streptococcal, Goodpasture syndrome, granulomatosis with polyangitis, polyarteritis nodosa, etc.).
. Be on systemic immunosuppressive agents aside from those related to their renal transplant
. Have known HIV or primary immune deficiency
. Have a known potential immune-mediated disorder (pIMD)
. Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation