MISP 60528 Pneumococcal Vaccination

Montefiore Medicine Academic Health System

Status: Terminated

Conditions: Heart Transplant Infection Prevention

Treatments: Biological: PCV15

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04845945

MISP 60528 (Other Grant/Funding Number)

2021-12637

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4 participants in 3 patient groups

PCV15 only

Description:

Draw blood for ELISA and OPA, then administer PCV15

Treatment:

Biological: PCV15

PPS23 only

Description:

Draw blood for ELISA and OPA, then administer PPS23

PCV15 and PPS23

Description:

Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15

Treatment:

Biological: PCV15