MISP 60528 Pneumococcal Vaccination

February 2, 2026 updated by: Montefiore Medical Center

Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center, Infectious Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

We are excluding infants and children as they are immunologically different from adults, respond to vaccinations differently, and guidelines for childhood vaccination are different from those for adult vaccination.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PCV15 only
Draw blood for ELISA and OPA, then administer PCV15
Biological: PCV15
Blood draw after the vaccination
Other Names:
  • PPS23
  • PCV15 and PPS23
PPS23 only
Draw blood for ELISA and OPA, then administer PPS23
PCV15 and PPS23
Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15
Biological: PCV15
Blood draw after the vaccination
Other Names:
  • PPS23
  • PCV15 and PPS23

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine response
Time Frame: 12 weeks
Antibody levels
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype ELISA response
Time Frame: 12 weeks
Antibody production to specific serotype
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

Merck Sharp & Dohme LLC
Quest Clinical Research
Sunfire Biotechnologies

Investigators

  • Principal Investigator: Vagish Hemmige, MD, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

August 24, 2024

Study Completion (Actual)

August 24, 2024

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-12637
  • MISP 60528 (Other Grant/Funding Number: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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