MISP 60528 Pneumococcal Vaccination | NCT04845945

Studies
MISP 60528 Pneumococcal Vaccination

NCT04845945

Sponsor

Montefiore Medical Center

Status

Terminated

Last Update Posted

Feb 4, 2026Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Heart Transplant Infection Prevention

Interventions

PCV15

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MISP 60528	Other Grant/Funding Number	Merck

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Termination of funding by the sponsor/funder.

Expanded Access Info

Start Date

Jun 10, 2021Actual

Primary Completion Date

Aug 24, 2024Actual

Completion Date

Aug 24, 2024Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY
Sunfire Biotechnologies	UNKNOWN
Quest Clinical Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PCV15	Biological	Blood draw after the vaccination	PCV15 and PPS23 PCV15 only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaccine response	Antibody levels	12 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vagish Hemmige, MD	Montefiore Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center, Infectious Diseases		The Bronx	New York	10467	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided