MISP 60528 Pneumococcal Vaccination

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: Recruiting
• Conditions: Heart Transplant Infection Prevention
• Intervention / Treatment: Biological: PCV15

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 (Estimated): 45

Contacts and Locations

• Study Contact: Name: Vagish Hemmige, MD; Phone Number: 718-920-2705; Email: vahemmig@montefiore.org
• Study Contact Backup: Name: Margaret Mccort; Phone Number: 866-633-8255; Email: mnewmanmcc@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center, Infectious Diseases
      • Contact: Vagish Hemmige, MD; Phone Number: 718-920-2705; Email: vahemmig@montefiore.org
      • Contact: Margaret McCort, MD; Phone Number: 718-920-7361; Email: mnewmanmcc@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

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	Antibody levels	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Vagish Hemmige, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

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): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-12637

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