Request for proposal in support of National Institute of Allergy and Infectious Diseases (NIAID), Division of Microbiology and Infectious Diseases (DMID)T-Cell Analyses COVAIL Trial

Frederick National Laboratory for Cancer Research (FNLCR) Operated by Leidos Biomedical Research, Inc. (Leidos Biomed) for the National Cancer Institute requires a Standalone award for T-Cell Analyses in support the COVAIL trial. The FNLCR is a Government-Owned Contractor-Operated (GOCO) Federally Funded Research and Development Center (FFRDC) located at Fort Detrick, Maryland. The FNLCR partners with university, government, and corporate scientists to speed the translation of laboratory research into new diagnostic tests and treatments for cancer and AIDS. FNLCR is a multi-program laboratory currently operated by Leidos Biomedical Research Inc. (Leidos Biomed) for the National Cancer Institute (NCI) under Prime Contracts 75N91019D00024 & HHSN261201500003I. The Government assumes no liability for reimbursement for any effort or associated costs to respond, nor for any information provided as a result of this notice as no information is being requested. Please be advised that any submissions provided despite the aforementioned notice that no information is requested become Government property and will not be returned, nor will there be any ensuing discussions or debriefings of any responses. Responses submitted to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor this site and any sites referenced herein for additional information pertaining to business opportunities with the FNLCR, if any. Description of Work: In support of the NIAID DMID COVAIL trial, Leidos Biomed is tasked with the management, oversight, and conduct of the COVAIL trial and seeks to subcontract with a laboratory capable of successfully responding to this Statement of Work (SOW) to assess the SARS-CoV-2 spike protein specific T-cell responses of candidate SARS-CoV-2 variant vaccines to identify features that may correlate to protective vaccine responses to SARS-CoV-2. The successful Offeror shall be tasked with developing a sample analysis plan detailing how they will interrogate the T cell response from longitudinally collected peripheral blood mononuclear cells (PBMCs) post booster vaccination. Note: The Subcontractor is not expected to characterize the T cell response in every participant, but to focus on comparisons that are scientifically and statistically justified to help inform the field. For example, DMID is interested in understanding the breadth of immunological response elicited by different candidate vaccine formulations, defining the differential responses in participants that have or have not experienced breakthrough infections post-booster vaccination, as well as understanding the differences afforded by prior infection histories. Multiple subcontracts may be awarded to complement the full characterization of the T cell response. The analysis plan will be reviewed by Leidos Biomed to ensure that it meets the stated objectives as outlined in this SOW. Upon acceptance of the analysis plan, the Subcontractor shall be tasked with receiving and analyzing the PBMCs according to the stated plan. The scope of work includes multiple tasks that are to be conducted, including developing a Laboratory Analysis and Development Plan, incorporating any changes or revisions requested by Leidos Biomed, receiving and properly storing PBMC sample shipments, performing T-cell analysis, and reporting results. Leidos Biomedical Research, Inc. POC: To obtain a copy of the RFP please contact Maureen Wilson, Sr. Subcontracts Administrator, at [email protected]. For information concerning other opportunities with the FNLCR, please refer to: https://frederick.cancer.gov/workwithus/solicitations