MISP 60528 Pneumococcal Vaccination

NCT ID: NCT04845945

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2024-08-24

Brief Summary

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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

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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.

Conditions

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Heart Transplant Infection Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCV15 only

Draw blood for ELISA and OPA, then administer PCV15

PCV15

Intervention Type BIOLOGICAL

Blood draw after the vaccination

PPS23 only

Draw blood for ELISA and OPA, then administer PPS23

No interventions assigned to this group

PCV15 and PPS23

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

PCV15

Intervention Type BIOLOGICAL

Blood draw after the vaccination

Interventions

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PCV15

Blood draw after the vaccination

Intervention Type BIOLOGICAL

Other Intervention Names

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PPS23 PCV15 and PPS23

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Sunfire Biotechnologies

UNKNOWN

Sponsor Role collaborator

Quest Clinical Research

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vagish Hemmige, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center, Infectious Diseases

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MISP 60528

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-12637

Identifier Type: -

Identifier Source: org_study_id

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