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Solid Organ Transplant SHINGRIX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993717
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

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 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 and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant. The duration of the study is 180 days.


Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Biological: SHINGRIX Phase 4

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 and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant.

This is a clinical trial that will be 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.

This study could help assess safety and efficacy of the SHINGRIX vaccine and also determine the optimal timing of vaccination in Kidney Transplant patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective assignment, open label
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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
Other Name: Zoster vaccine recombinant

Experimental: 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
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
Other Name: Zoster vaccine recombinant




Primary Outcome Measures :
  1. Change in levels of Anti-gE antibody concentrations [ Time Frame: Day 1, Day 61, Day 180 ]
    Anti-gE antibody concentrations will be obtained via enzyme-linked immunosorbent assay (ELISA)

  2. Change in number of subjects with a vaccine response for anti-gE antibody [ Time Frame: Day 61, Day 180 ]

    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.


Secondary Outcome Measures :
  1. Number of subjects with any related severe adverse events (SAEs) [ Time Frame: Day 180 ]
    Number of participants with SAEs from first vaccination until the end of the trial

  2. Number of subjects with any grade 3 related adverse events (AEs) [ Time Frame: Day 91 ]
    Number of subjects with any grade 3 related AEs from each vaccination and until 15 days after each vaccination

  3. Number of subjects with renal allograft rejection [ Time Frame: Day 180 ]
    Number of subjects with renal allograft rejection from first vaccination until the end of the trial

  4. Number of subjects with changes in allograft function [ Time Frame: Day 180 ]

    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)


  5. Change in HLA antibody titers [ Time Frame: Day 1, Day 15, Day 61, Day 75, Day 180 ]
    HLA antibody titers will be measured and analyzed at different time points



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993717


Contacts
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Contact: Nadine Rouphael, MD 404-712-1435 nroupha@emory.edu

Locations
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United States, Georgia
Hope Clinic Recruiting
Atlanta, Georgia, United States, 30030
Contact: Nadine Rouphael, MD    404-712-1435    nroupha@emory.edu   
Emory University Hospital Clinical Research Network Recruiting
Atlanta, Georgia, United States, 30322
Contact: Nadine Rouphael, MD    404-712-1435    nroupha@emory.edu   
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30324
Contact: Nadine Rouphael, MD    404-712-1435    nroupha@emory.edu   
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30324
Contact: Nadine Rouphael, MD    404-712-1435    nroupha@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Nadine Rouphael, MD Emory University

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Responsible Party: Nadine Rouphael, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03993717    
Other Study ID Numbers: IRB00109207
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nadine Rouphael, Emory University:
shingles vaccine
immune responses
Clinical Trials
Immunology
Kidney Transplant
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs