Solid Organ Transplant SHINGRIX

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03993717
• Other study ID #: IRB00109207
• Status: Terminated
• Start date: January 30, 2020
• Est. completion date: August 8, 2020

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 8, 2020
• Est. primary completion date: August 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Clinical Research Network	Atlanta	Georgia
United States	Hope Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of subjects with any related severe adverse events (SAEs)	Number of participants with SAEs from first vaccination until the end of the trial	Day 180
Secondary	Number of subjects with any grade 3 related adverse events (AEs)	Number of subjects with any grade 3 related AEs from each vaccination and until 15 days after each vaccination	Day 91
Secondary	Number of subjects with renal allograft rejection	Number of subjects with renal allograft rejection from first vaccination until the end of the trial	Day 180
Secondary	Number of subjects with changes in allograft function	Number of subjects with changes in allograft function from first vaccination until the end of the trial.; Allograft function will be defined as increase in serum creatinine levels (= 1.25, = 1.50, = 1.75 or = 2 fold increase)	Day 180
Secondary	Change in HLA antibody titers	HLA antibody titers will be measured and analyzed at different time points	Day 1, Day 15, Day 61, Day 75, Day 180