Heart Transplant Infection PreventionNCT04845945
MISP 60528 Pneumococcal Vaccination
An observational study of Heart Transplant Infection Prevention, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Infection Prevention
- What is being tested?
- PCV15
- Type of treatment
- Vaccines
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2021to 24 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Infants and children under age 18
- Subjects without the capacity to consent
- Pregnancy
- Already up to date on pneumococcal vaccination or declining vaccination
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center, Infectious Diseases
The Bronx, New York, 10467
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Transplant Infection Prevention
- Being tested
- PCV15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV15Biological
Also called PPS23, PCV15 and PPS23
Blood draw after the vaccination
| Study group | Role | What they receive |
|---|---|---|
| PCV15 only | Draw blood for ELISA and OPA, then administer PCV15 Receives: 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 Receives: Biological: PCV15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine response
Antibody levels
Measured: 12 weeks
Secondary outcomes (1)
Serotype ELISA response
Antibody production to specific serotype
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start10 Jun 2021
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Why it stopped: Termination of funding by the sponsor/funder.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant Infection PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sunfire Biotechnologies, Quest Clinical Research
- Responsible party
- Sponsor
- Investigators
- Vagish Hemmige, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845945
- Sponsor's protocol ID
- 2021-12637
- Other IDs
- MISP 60528
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients
- ClinicalTrials.gov ID
- NCT04845945
- Acronym / sponsor ID
- 2021-12637
- Conditions
- Heart Transplant Infection Prevention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of funding by the sponsor/funder.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Sunfire Biotechnologies, Quest Clinical Research
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCV15 only | – | Biological: PCV15Draw blood for ELISA and OPA, then administer PCV15 |
| PPS23 only | – | –Draw blood for ELISA and OPA, then administer PPS23 |
| PCV15 and PPS23 | – | Biological: PCV15Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Infants and children under age 18
- Subjects without the capacity to consent
- Pregnancy
- Already up to date on pneumococcal vaccination or declining vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV15Also: PPS23, PCV15 and PPS23Blood draw after the vaccination | Biological | PCV15 and PPS23, PCV15 only |
Primary outcome
Vaccine response
Time frame: 12 weeks
Antibody levels
1 secondary outcome
Serotype ELISA response
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Termination of funding by the sponsor/funder.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vagish Hemmige, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Infection Prevention, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Termination of funding by the sponsor/funder.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.