MedTrace Logo

Solid Organ Transplant SHINGRIX

NCT03993717 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2024-02-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2020-08-08
Completion
2020-08-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993717 on ClinicalTrials.gov