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Due to personnel changes and COVID-19.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three to six months post-transplant Group | Subjects in this arm will receive the SHINGRIX vaccine three to six months after kidney transplant |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 61, Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of subjects with any grade 3 related adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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Solid Organ Transplant kidney recipients
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Rouphael, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinic | Atlanta | Georgia | 30030 | United States | ||
| Emory University Hospital Clinical Research Network |
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Number of subjects with any grade 3 related AEs from each vaccination and until 15 days after each vaccination
| Day 91 |
| 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 |
| 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 |
| 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 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Emory Clinic | Atlanta | Georgia | 30324 | United States |
| Emory University Hospital | Atlanta | Georgia | 30324 | United States |