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Article History

Received: 1 December 2017

Accepted: 26 February 2018

First Online: 6 March 2018

Authors’ information

: ROD is a former president of the Society for Immunotherapy of Cancer (2000–2002, then called the International Society for the Biotherapy of Cancer) after serving two previous terms on its Board of Directors. For more than a decade he was Chairman of the Cancer Biotherapy Research Group. From 1989 to 2011 he was Medical Director of the Hoag Cancer Center, where this trial was conducted, and Scientific Director for the Hoag Cell Biology Laboratory, where the investigational products used in this trial were manufactured.

: The MACVAC clinical trial was conducted per the Declaration of Helsinki after approval by the Western Institutional Review Board (Seattle, WA), and in accord with assurances filed with and approved by the Department of Health and Human Services. All patients gave written informed consent prior to randomization. In addition to Institutional Review Board oversight, conduct of the trial was monitored by an external consultant, and Hoag Hospital’s institutional clinical research oversight committee. The protocol and manufacturing procedures were reviewed by the US Food and Drug Administration in association with BB-IND 5838 for the tumor cell vaccine, 8554 for the dendritic cell vaccine. The trial was registered on ClinicalTrials.gov (NCT00436930) on 28 July 2009.

: Not applicable

: ROD is an employ of AIVITA Biomedical, Inc. ANC is an employee of TCR2. GIN is an employ of AVITIA Biomedical, Inc. ROD, ANC, and GIN are former employees of Caladrius Biosciences, Inc. and retain stock in that company. None of the other authors declared any conflicts as related to this trial.

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