Kidney Transplant; ComplicationsNCT03993717
Solid Organ Transplant SHINGRIX
An observational study of Kidney Transplant; Complications, run by Emory University at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- SHINGRIX
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jan 2020to 8 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid Organ Transplant kidney recipients
Who may be able to join
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending study visits according to the study schedule
- Males or females greater than or equal to 50 years of age.
- Oral temperature less than 38 C.
- Are in general good health, as determined by medical history and targeted physical exam related to this history
- Recent renal transplant (either 3-6 months or 12-36 months prior)
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- Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination
- Have received an ABO compatible allogeneic renal transplant
- Male subjects should agree not to contribute to conception of a child, including sperm donation, for the duration of the study.
Who cannot join
- Have received any transplant in addition to renal transplant
- Have an acute illness within 72 hours prior to vaccination
- Have a severe medical condition as determined by the investigators
- 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.).
- Be on systemic immunosuppressive agents aside from those related to their renal transplant
- Have known HIV or primary immune deficiency
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- Have a known potential immune-mediated disorder (pIMD)
- Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation
- Have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
- Have donated blood or blood products within 56 days before study vaccination and for the duration of the study
- Have received the Shingrix or Zostavax injection previously
- Have had Shingles in the past
- Be of child-bearing potential
- Have known recent exposure to wild-type varicella in the past 4 weeks
- Have a history of severe reactions following other vaccinations
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hope Clinic
Atlanta, Georgia, 30030
Emory University Hospital Clinical Research Network
Atlanta, Georgia, 30322
Emory Clinic
Atlanta, Georgia, 30324
Emory University Hospital
Atlanta, Georgia, 30324
About this study
Official title: Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients
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.
Read the 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
- Being tested
- SHINGRIX
- Keywords
- shingles vaccine, immune responses, Clinical Trials, Immunology, Kidney Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHINGRIXBiological
Also called Zoster vaccine recombinant
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
| Study group | Role | What they receive |
|---|---|---|
| Three to six months post-transplant Group | Subjects in this arm will receive the SHINGRIX vaccine three to six months after kidney transplant Receives: Biological: SHINGRIX | |
| 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 Receives: Biological: SHINGRIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of Anti-gE antibody concentrations
Anti-gE antibody concentrations will be obtained via enzyme-linked immunosorbent assay (ELISA)
Measured: Day 1, Day 61, Day 180
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.
Measured: Day 61, Day 180
Secondary outcomes (5)
Number of subjects with any related severe adverse events (SAEs)
Number of participants with SAEs from first vaccination until the end of the trial
Measured: Day 180
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
Measured: 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
Measured: 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)
Measured: Day 180
Change in HLA antibody titers
HLA antibody titers will be measured and analyzed at different time points
Measured: Day 1, Day 15, Day 61, Day 75, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start30 Jan 2020
- Primary completion8 Aug 2020
- Study completion8 Aug 2020
Why it stopped: Due to personnel changes and COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993717
- Sponsor's protocol ID
- IRB00109207
- Status last verified
- Feb 2024
- First submitted
- 18 Jun 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03993717
- Acronym / sponsor ID
- IRB00109207
- Conditions
- Kidney Transplant; Complications
- Keywords
- shingles vaccine, immune responses, Clinical Trials, Immunology, Kidney Transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to personnel changes and COVID-19.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three to six months post-transplant Group | – | Biological: SHINGRIXSubjects in this arm will receive the SHINGRIX vaccine three to six months after kidney transplant |
| Twelve to thirty-six months post-transplant Group | – | Biological: SHINGRIXSubjects in this arm will receive the SHINGRIX vaccine twelve to thirty-six months after kidney transplant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid Organ Transplant kidney recipients
Key inclusion criteria (9 listed)
- Capable of informed consent and provision of written informed consent before any study procedures.
- Capable of attending study visits according to the study schedule
- Males or females greater than or equal to 50 years of age.
- Oral temperature less than 38 C.
- Are in general good health, as determined by medical history and targeted physical exam related to this history
Key exclusion criteria (15 listed)
- Have received any transplant in addition to renal transplant
- Have an acute illness within 72 hours prior to vaccination
- Have a severe medical condition as determined by the investigators
- 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.).
- Be on systemic immunosuppressive agents aside from those related to their renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHINGRIXAlso: Zoster vaccine recombinantA 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 | Biological | Three to six months post-transplant Group, Twelve to thirty-six months post-transplant Group |
Primary outcome
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)
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.
5 secondary outcomes
Number of subjects with any related severe adverse events (SAEs)
Time frame: Day 180
Number of subjects with any grade 3 related adverse events (AEs)
Time frame: Day 91
Number of subjects with renal allograft rejection
Time frame: Day 180
Number of subjects with changes in allograft function
Time frame: Day 180
Change in HLA antibody titers
Time frame: Day 1, Day 15, Day 61, Day 75, Day 180
Results and safety
The study was stopped early (reason given: Due to personnel changes and COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Rouphael, MD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant; Complications, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to personnel changes and COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of Anti-gE antibody concentrations (time frame: Day 1, Day 61, Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.