Solid Organ Transplant SHINGRIX

Stopped early

Conditions studied: Kidney Transplant; Complications

In brief

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.

Key facts

Study ID

NCT03993717

Run by

Emory University

People needed

2

Starts

2020-01-30

Expected to finish

2020-08-08

Last updated by the study team

2024-02-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Recent renal transplant (either 3-6 months or 12-36 months prior)
• Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination
• Have received an ABO compatible allogeneic renal transplant
• Male subjects should agree not to contribute to conception of a child, including sperm donation, for the duration of the study.

You may not qualify if…

• 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
• Have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
• Have donated blood or blood products within 56 days before study vaccination and for the duration of the study
• Have received the Shingrix or Zostavax injection previously
• Have had Shingles in the past
• Be of child-bearing potential
• Have known recent exposure to wild-type varicella in the past 4 weeks
• Have a history of severe reactions following other vaccinations

Where it is running

• Hope Clinic — Atlanta, Georgia, United States
• Emory University Hospital Clinical Research Network — Atlanta, Georgia, United States
• Emory Clinic — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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