NCT04845945

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2024

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

March 19, 2021

Last Update Submit

February 2, 2026

Conditions

Heart Transplant Infection Prevention

Outcome Measures

Primary Outcomes (1)

  • Vaccine response

    Antibody levels

    12 weeks

Secondary Outcomes (1)

  • Serotype ELISA response

    12 weeks

Study Arms (3)

PCV15 only

Draw blood for ELISA and OPA, then administer PCV15

Biological: PCV15

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

Interventions

PCV15BIOLOGICAL

Blood draw after the vaccination

Also known as: PPS23, PCV15 and PPS23
PCV15 and PPS23PCV15 only

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Infants and children under age 18
  • Subjects without the capacity to consent
  • Pregnancy
  • Already up to date on pneumococcal vaccination or declining vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center, Infectious Diseases

The Bronx, New York, 10467, United States

Location

Study Officials

  • Vagish Hemmige, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 15, 2021

Study Start

June 10, 2021

Primary Completion

August 24, 2024

Study Completion

August 24, 2024

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)