Solid Organ Transplant SHINGRIX

NCT03993717 | Terminated FDA Drug

• 1 other identifier: IRB00109207
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Kidney Transplant; Complications

Keywords

shingles vaccine; immune responses; Clinical Trials; Immunology; Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• Change in levels of Anti-gE antibody concentrations

  Anti-gE antibody concentrations will be obtained via enzyme-linked immunosorbent assay (ELISA)

  Day 1, Day 61, Day 180

• Change in number of subjects with a vaccine response for anti-gE antibody

  Vaccine response is defined as: * For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]) * For initially seropositive subjects (defined as ≥ 97 mIU/ml), antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

  Day 61, Day 180

Secondary Outcomes (5)

• Number of subjects with any related severe adverse events (SAEs)

  Day 180

• Number of subjects with any grade 3 related adverse events (AEs)

  Day 91

• Number of subjects with renal allograft rejection

  Day 180

• Number of subjects with changes in allograft function

  Day 180

• Change in HLA antibody titers

  Day 1, Day 15, Day 61, Day 75, Day 180

Study Arms (2)

Three to six months post-transplant Group

Subjects in this arm will receive the SHINGRIX vaccine three to six months after kidney transplant

Biological: SHINGRIX

Twelve to thirty-six months post-transplant Group

Subjects in this arm will receive the SHINGRIX vaccine twelve to thirty-six months after kidney transplant

Biological: SHINGRIX

Interventions

SHINGRIX BIOLOGICAL

A single intramuscular injection of the FDA-approved recombinant glycoprotein E herpes zoster (HZ/su) vaccine will be administered in the deltoid muscle of the preferred arm

Also known as: Zoster vaccine recombinant

Three to six months post-transplant Group; Twelve to thirty-six months post-transplant Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Solid Organ Transplant kidney recipients

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Hope Clinic

Atlanta, Georgia, 30030, United States

Location

Emory University Hospital Clinical Research Network

Atlanta, Georgia, 30322, United States

Location

Emory Clinic

Atlanta, Georgia, 30324, United States

Location

Emory University Hospital

Atlanta, Georgia, 30324, United States

Location

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: January 30, 2020
• Primary Completion: August 8, 2020
• Study Completion: August 8, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)