Solid Organ Transplant SHINGRIX

NCT ID: NCT03993717

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2020-08-08

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.

Detailed Description

Shingles is a viral illness caused by the same virus that causes the chicken pox. Reactivation of this virus leads to shingles which is a painful blistering rash. Around 10% of organ transplant patients get shingles. This study will help us assess the safety and efficacy of a new shingles vaccine, SHINGRIX in Kidney Transplant patients. SHINGRIX is FDA approved for the prevention of shingles.

In this study, 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.

This research is conducted at the Emory University Hospital and Emory Clinics. Additionally follow up visits might also be conducted at the Emory Hope Clinic, the clinical arm of the Emory Vaccine Center.

Subjects will be identified through review of medical records or by referral from their healthcare providers. Subjects may also self-refer from the IRB approved recruitment flyers. Following identification/referral, a coordinator or recruiter will contact the subject and tell them about the study and see if he/she is interested. If the potential subject is interested, the recruiter will obtain an oral consent and prescreen them for the study using a screening checklist. Qualified subjects will be scheduled to come into the clinic and be fully consented and proceed with screening/enrollment.

Blood specimens will be collected and stored for the research study and for future use. Subjects can opt to have their information stored in a Hope Clinic database in order to contact them for other studies they may qualify for in the future. There are no other optional studies planned at this time.

Conditions

Kidney Transplant; Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Three to six months post-transplant Group

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

SHINGRIX

Intervention Type: 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

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

SHINGRIX

Intervention Type: 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

Interventions

SHINGRIX

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Zoster vaccine recombinant

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Rouphael

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine Rouphael, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

Countries

United States

Other Identifiers

IRB00109207

Identifier Type: -

Identifier Source: org_study_id