NCT04951323

Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)

Status unknown Phase 3 Last updated 18 May 2022

What this trial tests

Phase 3 trial testing anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) in Coronavirus Disease 2019 (Covid19) in 50 participants. Status unknown.

Timeline

22 March 2021

Primary endpoint
1 December 2022

1 January 2023

Quick facts

Lead sponsor	University of Liege
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	22 March 2021
Primary completion	1 December 2022
Estimated completion	1 January 2023
Sites	1 location across Belgium

Drugs / interventions tested

• anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer) — full drug profile →

Conditions studied

• Coronavirus Disease 2019 (Covid19) — all drugs for Coronavirus Disease 2019 (Covid19) →
• Hematopoietic Neoplasms — all drugs for Hematopoietic Neoplasms →

Sponsor

University of Liege

Who can join

Adults 18 to 100, any sex, with Coronavirus Disease 2019 (Covid19) or Hematopoietic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. COVID-19 mRNA vaccines: Platforms and current developments.
   Szabó GT, Mahiny AJ, Vlatkovic I. · · 2022 · cited 198× · PMID 35189345 · DOI 10.1016/j.ymthe.2022.02.016
2. Therapeutic cancer vaccines: From biological mechanisms and engineering to ongoing clinical trials.
   Sobhani N, Scaggiante B, Morris R, Chai D, et al · · 2022 · cited 57× · PMID 35759856 · DOI 10.1016/j.ctrv.2022.102429
3. Vaccines for COVID-19: A Systematic Review of Immunogenicity, Current Development, and Future Prospects.
   Zhang Z, Shen Q, Chang H. · · 2022 · cited 44× · PMID 35572592 · DOI 10.3389/fimmu.2022.843928
4. Nanoparticles in clinical trials of COVID-19: An update.
   Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
5. The clinical impact of mRNA therapeutics in the treatment of cancers, infections, genetic disorders, and autoimmune diseases.
   Deyhimfar R, Izady M, Shoghi M, Kazazi MH, et al · · 2024 · cited 17× · PMID 38486748 · DOI 10.1016/j.heliyon.2024.e26971
6. Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment.
   Zou H, Yang Y, Dai H, Xiong Y, et al · · 2021 · cited 12× · PMID 34880750 · DOI 10.3389/fphar.2021.732403
7. Applications of mRNA Delivery in Cancer Immunotherapy.
   Pan X, Zhang YW, Dai C, Zhang J, et al · · 2025 · cited 11× · PMID 40125430 · DOI 10.2147/ijn.s500520
8. COVID-19, the firestone in 21st century: a review on coronavirus disease and its clinical perspectives.
   Karthika C, Swathy Krishna R, Rahman MH, Akter R, et al · · 2021 · cited 11× · PMID 34599450 · DOI 10.1007/s11356-021-16654-9