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 range50 Years
SexALL
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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 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