COVID-19 3rd Dose Vaccine in Transplant Patients

Giselle Guerra

Status and phase

Terminated

Phase 3

Conditions

Covid19

Treatments

Biological: BNT162b2 vaccine

Biological: JNJ-78436735 Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT05047640

20210641

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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