MISP 60528 Pneumococcal Vaccination

Montefiore Medical Center4 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Transplant Infection Prevention

Interventions

PCV15BIOLOGICAL

Blood draw after the vaccination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center, Infectious Diseases

The Bronx, New York, United States

Outcomes

Primary Outcomes

Vaccine response

Antibody levels

Time frame: 12 weeks

Secondary Outcomes

Serotype ELISA response

Antibody production to specific serotype

Time frame: 12 weeks

Data from ClinicalTrials.gov

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