Heart Transplant Infection Prevention
Conditions
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.
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.
Interventions
BIOLOGICALPCV15
Blood draw after the vaccination
Sponsors
Montefiore Medical Center
Merck Sharp & Dohme LLC
Sunfire Biotechnologies
Quest Clinical Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine response | 12 weeks | Antibody levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype ELISA response | 12 weeks | Antibody production to specific serotype |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVagish Hemmige, MD
Montefiore Medical Center
Outcome results
None listed