Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients

IRB00109207

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.

2020-01-30

2020-08-08

2020-08-08

Terminated

2

Inclusion Criteria: 1. Capable of informed consent and provision of written informed consent before any study procedures. 2. Capable of attending study visits according to the study schedule 3. Males or females greater than or equal to 50 years of age. 4. Oral temperature less than 38 C. 5. Are in general good health, as determined by medical history and targeted physical exam related to this history 6. Recent renal transplant (either 3-6 months or 12-36 months prior) 7. Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination 8. Have received an ABO compatible allogeneic renal transplant 9. Male subjects should agree not to contribute to conception of a child, including sperm donation, for the duration of the study. Exclusion Criteria: 1. Have received any transplant in addition to renal transplant 2. Have an acute illness within 72 hours prior to vaccination 3. Have a severe medical condition as determined by the investigators 4. 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.). 5. Be on systemic immunosuppressive agents aside from those related to their renal transplant 6. Have known HIV or primary immune deficiency 7. Have a known potential immune-mediated disorder (pIMD) 8. Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation 9. Have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine 10. Have donated blood or blood products within 56 days before study vaccination and for the duration of the study 11. Have received the Shingrix or Zostavax injection previously 12. Have had Shingles in the past 13. Be of child-bearing potential 14. Have known recent exposure to wild-type varicella in the past 4 weeks 15. Have a history of severe reactions following other vaccinations

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2024-02-20