Covid19Phase 3NCT05047640
COVID-19 3rd Dose Vaccine in Transplant Patients
A Phase 3 study testing BNT162b2 vaccine and JNJ-78436735 Vaccine in people with Covid19, run by Giselle Guerra at 1 site in United States.
Trial summary
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- BNT162b2 vaccine and JNJ-78436735 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 25 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age and older
- Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
- Patients with active graft with at least one immunosuppressive medication
- Completed two doses of BNT162b2 vaccination at least 28 days ago
Who cannot join
- Patient with non-active graft
- Any significant side effect with previous COVID-19 vaccination
- Within 28 days of BNT162b2 vaccine completion
- Already received more than and equal to three doses of COVID-19 vaccination
- Previously received COVID-19 vaccine other than BNT162b2 vaccine
- Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination.
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- Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)
- History of Capillary Leak Syndrome
- Adults unable to consent
- Individuals who are not yet adults (younger than 18 year old)
- Vulnerable patients (prisoners)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
- Conditions
- Covid19
- Being tested
- BNT162b2 vaccine, JNJ-78436735 Vaccine
- Keywords
- transplant patients
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 vaccineBiological
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
JNJ-78436735 VaccineBiological
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 vaccine Group | Experimental | Participants in this arm will receive one booster dose of the BNT162b2. Receives: Biological: BNT162b2 vaccine |
| JNJ-78436735 vaccine Group | Experimental | Participants in this arm will receive one booster dose of the JNJ-78436735 Receives: Biological: JNJ-78436735 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
Measured: Up to 1 month (post booster vaccination)
Secondary outcomes (3)
Proportion of Participants With a Positive COVID-19 Test
As assessed by medical records and or patient's report
Measured: Up to 1 month (post third dose)
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
World Health Organization (WHO) scale is scored between from 0 -10.
0: Uninfected; non-viral Ribonucleic Acid (RNA) detected
- Asymptomatic; viral RNA detected
- Symptomatic; Independent
- Symptomatic; Assistance needed
- Hospitalized; No oxygen therapy
- Hospitalized; oxygen by mask or nasal prongs
- Hospitalized; oxygen by Non-invasive Ventilation (NIV) or High flow
- Intubation and Mechanical ventilation, partial pressure of oxygen (pO2) /fraction of inspired oxygen (FIO2) >=150 or oxygen saturation (SpO2) /FIO2>=200
- Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) or vasopressors (norepinephrine >0.3 microg/kg/min)
- Mechanical ventilation, pO2/FIO2<150 and vasopressors (norepinephrine >0.3 microg/kg/min), or Dialysis or extracorporeal membrane oxygenation (ECMO)
- Dead
Measured: Up to 1 month (post third dose)
Number of Participants With Vaccine-related Adverse Events
Number of Participants with vaccine-related adverse events as collected by the study team.
Measured: Up to 7 days (post third dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start14 Sep 2021
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giselle Guerra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giselle Guerra, University of Miami
- Investigators
- Giselle Guerra, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047640
- Sponsor's protocol ID
- 20210641
- Status last verified
- May 2024
- First submitted
- 13 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Natori Y, Martin E, Mattiazzi A, Arosemena L, Burke GW, Munagala MR, Manickavel S, Sota K, Pallikkuth S, Chen J, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. Post hoc analysis: 6 Months immunogenicity after third dose of BNT162b2 vs JNJ-78,436,735 after two doses of BNT162b2 vaccine in solid organ transplant recipients. Immunol Lett. 2025 Jun;273:106968. doi: 10.1016/j.imlet.2024.106968. Epub 2025 Jan 9.
PubMed 39798807Natori Y, Martin E, Mattiazzi A, Arosemena L, Ortigosa-Goggins M, Shobana S, Roth D, Kupin WL, Burke GW, Ciancio G, Morsi M, Phancao A, Munagala MR, Butrous H, Manickavel S, Sinha N, Sota K, Pallikkuth S, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients. Transpl Int. 2023 Apr 5;36:10938. doi: 10.3389/ti.2023.10938. eCollection 2023.
PubMed 37091963
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT05047640
- Acronym / sponsor ID
- 20210641
- Conditions
- Covid19
- Keywords
- transplant patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Giselle GuerraUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNT162b2 vaccine Group | Experimental | Biological: BNT162b2 vaccineParticipants in this arm will receive one booster dose of the BNT162b2. |
| JNJ-78436735 vaccine Group | Experimental | Biological: JNJ-78436735 VaccineParticipants in this arm will receive one booster dose of the JNJ-78436735 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years of age and older
- Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
- Patients with active graft with at least one immunosuppressive medication
- Completed two doses of BNT162b2 vaccination at least 28 days ago
Key exclusion criteria (12 listed)
- Patient with non-active graft
- Any significant side effect with previous COVID-19 vaccination
- Within 28 days of BNT162b2 vaccine completion
- Already received more than and equal to three doses of COVID-19 vaccination
- Previously received COVID-19 vaccine other than BNT162b2 vaccine
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 |
|---|---|---|
| BNT162b2 vaccineSingle dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle | Biological | BNT162b2 vaccine Group |
| JNJ-78436735 VaccineSingle dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle | Biological | JNJ-78436735 vaccine Group |
Primary outcome
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time frame: Up to 1 month (post booster vaccination)
Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
3 secondary outcomes
Proportion of Participants With a Positive COVID-19 Test
Time frame: Up to 1 month (post third dose)
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
Time frame: Up to 1 month (post third dose)
Number of Participants With Vaccine-related Adverse Events
Time frame: Up to 7 days (post third dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39798807Natori Y, Martin E, Mattiazzi A, Arosemena L, Burke GW, Munagala MR, Manickavel S, Sota K, Pallikkuth S, Chen J, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. Post hoc analysis: 6 Months immunogenicity after third dose of BNT162b2 vs JNJ-78,436,735 after two doses of BNT162b2 vaccine in solid organ transplant recipients. Immunol Lett. 2025 Jun;273:106968. doi: 10.1016/j.imlet.2024.106968. Epub 2025 Jan 9.
- Derived from this study: PubMed 37091963Natori Y, Martin E, Mattiazzi A, Arosemena L, Ortigosa-Goggins M, Shobana S, Roth D, Kupin WL, Burke GW, Ciancio G, Morsi M, Phancao A, Munagala MR, Butrous H, Manickavel S, Sinha N, Sota K, Pallikkuth S, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients. Transpl Int. 2023 Apr 5;36:10938. doi: 10.3389/ti.2023.10938. eCollection 2023.
- 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.
Giselle Guerra, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNT162b2 vaccine and JNJ-78436735 Vaccine in people with Covid19, run by Giselle Guerra 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 4 inclusion and 12 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 Jun 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (time frame: Up to 1 month (post booster vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047640, which also lists 2 linked publications.
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 Jun 2024.