Evaluating pneumococcal vaccination responses in heart transplant candidates
Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients
This study tests how well pneumococcal vaccines work in people being evaluated for a heart transplant, including those with a left ventricular assist device, to see if the current vaccination methods are good enough for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT04845945 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the immune response to pneumococcal vaccination in patients undergoing evaluation for heart transplant, including those who have received a left ventricular assist device (LVAD). Participants will receive vaccinations according to standard care guidelines, while their responses will be assessed using two blood tests: ELISA and OPA. The study aims to determine if current vaccination strategies are sufficient for this high-risk population. Participation involves minimal additional risk, primarily associated with blood sample collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who are either being evaluated for a heart transplant or have already received one.
Not a fit: Patients who are under 18, pregnant, or already up to date on pneumococcal vaccination will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve vaccination strategies for heart transplant candidates, enhancing their infection prevention.
How similar studies have performed: While this approach is observational and builds on existing vaccination guidelines, similar studies have shown the importance of tailored vaccination strategies in immunocompromised populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bronx, New York
- Montefiore Medical Center, Infectious Diseases — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Vagish Hemmige, MD — Montefiore Medical Center
- Study coordinator: Vagish Hemmige, MD
- Email: vahemmig@montefiore.org
- Phone: 718-920-2705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.