drugset / Trial / NCT05047640
COVID-19 3rd Dose Vaccine in Transplant Patients
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2021-09-14
- Primary completion
- 2022-10-25
- Completion
- 2022-10-25
Outcome
Missed primary endpoint
Stopped (Enrollment): “Difficulty in recruitment”
paper There were no statistically significant differences between the two vaccine protocols for IgG positivity (83.3% vs. 85.2% for BNT162b2 and JNJ-78436735, respectively, p = 0.85 PMID 37091963 ↗
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ad26.COV2.S | Vaccine | — | Intramuscular |
| Subject | BNT162b2 | Messenger RNA (mRNA) | 0.3 ml | Intramuscular |