Brief Summary
This study aims to use two different blood tests (ELISA and OPA) to study response to pneumococcal vaccination administered as per standard guidelines in patients who are undergoing workup for heart transplant (whether or not they have undergone LVAD implantation or have undergone heart transplant.
Brief Title
MISP 60528 Pneumococcal Vaccination
Detailed Description
The patients will be receiving vaccination consistent with standard of care guidelines, regardless of study participation. The additional risk of study participation would be the risks associated with venipuncture (injury to vessel or nerve, syncope).
Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.
Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-2705
Central Contact Email
vahemmig@montefiore.org
Central Contact Role
Contact
Central Contact Phone
866-633-8255
Central Contact Email
mnewmanmcc@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Heart Transplant Infection Prevention
Eligibility Criteria
Inclusion Criteria:
* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines
Exclusion Criteria:
* Infants and children under age 18
* Subjects without the capacity to consent
* Pregnancy
* Already up to date on pneumococcal vaccination or declining vaccination
* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines
Exclusion Criteria:
* Infants and children under age 18
* Subjects without the capacity to consent
* Pregnancy
* Already up to date on pneumococcal vaccination or declining vaccination
Inclusion Criteria
Inclusion Criteria:
* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines
* Age 18 or over
* Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
* Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines
Gender
All
Gender Based
false
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04845945
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-12637
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients
Primary Outcomes
Outcome Description
Antibody levels
Outcome Measure
Vaccine response
Outcome Time Frame
12 weeks
Secondary Outcomes
Outcome Description
Antibody production to specific serotype
Outcome Time Frame
12 weeks
Outcome Measure
Serotype ELISA response
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
We are excluding infants and children as they are immunologically different from adults, respond to vaccinations differently, and guidelines for childhood vaccination are different from those for adult vaccination.
Std Ages
Adult
Older Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Vagish Hemmige
Investigator Email
vahemmig@montefiore.org
Investigator Phone
718-920-0705