COVID-19 3rd Dose Vaccine in Transplant Patients

NCT05047640 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 20210641
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Keywords

transplant patients

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 1 month (post booster vaccination)

Secondary Outcomes (3)

• Proportion of Participants With a Positive COVID-19 Test

  Up to 1 month (post third dose)

• Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale

  Up to 1 month (post third dose)

• Number of Participants With Vaccine-related Adverse Events

  Up to 7 days (post third dose)

Study Arms (2)

BNT162b2 vaccine Group

EXPERIMENTAL

Participants in this arm will receive one booster dose of the BNT162b2.

Biological: BNT162b2 vaccine

JNJ-78436735 vaccine Group

EXPERIMENTAL

Participants in this arm will receive one booster dose of the JNJ-78436735

Biological: JNJ-78436735 Vaccine

Interventions

BNT162b2 vaccine BIOLOGICAL

Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle

BNT162b2 vaccine Group

JNJ-78436735 Vaccine BIOLOGICAL

Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle

JNJ-78436735 vaccine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Giselle Guerra: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

• 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.

  PMID: 39798807 DERIVED

• Natori 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.

  PMID: 37091963 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine; Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Giselle Guerra
• Organization: University of Miami

gguerra@med.miami.edu

3053555803

Study Officials

• Giselle Guerra, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of Transplant Services

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 17, 2021
• Study Start: September 14, 2021
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: June 4, 2024
• Results First Posted: June 22, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)