MISP 60528 Pneumococcal Vaccination
- Registration Number
- NCT04845945
- Lead Sponsor
- Montefiore Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- Infants and children under age 18
- Subjects without the capacity to consent
- Pregnancy
- Already up to date on pneumococcal vaccination or declining vaccination
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PCV15 and PPS23 PCV15 Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15 PCV15 only PCV15 Draw blood for ELISA and OPA, then administer PCV15
- Primary Outcome Measures
Name Time Method Vaccine response 12 weeks Antibody levels
- Secondary Outcome Measures
Name Time Method Serotype ELISA response 12 weeks Antibody production to specific serotype
Trial Locations
- Locations (1)
Montefiore Medical Center, Infectious Diseases
🇺🇸Bronx, New York, United States