Booster Dose Trial

Phase 2 Terminated 106 enrolled Montefiore Medical Center Albert Einstein College of Medicine · collab National Cancer Institute (NCI) · collab The Leukemia and Lymphoma Society · collab

NaSingle-groupOpen-labelPrevention

Summary

The goal of this study is to assess the safety and effectiveness of COVID vaccine booster doses in patients with cancer who have not developed an antibody after the U.S. Food and Drug Administration (FDA) Emergency Use Authorized COVID primary vaccination series.

Timeline

Start: 2021-08-10
Primary completion: 2022-04-20
Completion: 2023-05-21

Outcome

Outcome not reported

Stopped (Business): “Due to decreased level of engagement and available funding, PI determined it appropriate to close the study prior to visit occurring. IRB approved.”

Publications

Thakkar A, Pradhan K, Duva B, Carreno JM, Sahu S, Thiruthuvanathan V, Campbell S, Gallego S, Bhagat TD, Rivera J, Choudhary G, Olea R, Sabalza M, Shapiro LC, Lee M, Quinn R, Mantzaris I, Chu E, Will B, Pirofski LA, Krammer F, Verma A, Halmos B. Study of efficacy and longevity of immune response to third and fourth doses of COVID-19 vaccines in patients with cancer: A single arm clinical trial. Elife. 2023 Mar 28;12:e83694. doi: 10.7554/eLife.83694.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BNT162b2	Messenger RNA (mRNA)	—	—