The Collaborative Clinical Research Branch (CCRB) is responsible for the Statement of Work of the CCRB Support Laboratories (Applied and Developmental Research Directorate, Leidos Biomedical Inc.), which are contracted through the National Cancer Institute-Frederick. The Laboratories support NIAID clinical trials and basic researchers. The Contracting Officer’s Representative (COR) is a member of the CCRB and are heavily involved with review and facilitating the work and collaborations with scientists, budget, and oversight to ensure compliance with the NIAID mission. The Laboratories collaborate with NIAID-sponsored networks and trials such as the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), the NIAID Influenza Research Collaboration, Accelerating COVID-19 Therapeutics and Interventions (ACTIV), and Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE).
The Laboratories provide assay development and repository services to urgent and compelling public health concerns such as HIV, influenza, Ebola, Zika, SARS-CoV-2, MPOX, and other emerging and re-emerging infectious diseases. The Laboratories also assist with research for vaccines like HIV and Ebola. The Laboratories use novel antigen and antibody assays for SARS-CoV-2 in conjunction with host biomarkers to analyze specimens from NIAID-sponsored clinical trials and studies on therapeutics and vaccines.
The Laboratories perform assays that include but are not limited to: immune functions, viral loads, biomarkers using ELISA/MESO technology, advanced flow cytometry (clinical and research), cell sorting by FACS and/or magnetic beads, cellular proliferation, influenza Hemagglutination Inhibition Assay, EBV cell lines, luciferase immunoprecipitation systems (LIPS) assay, quantitative antigen and antibody assays, Illumina sequencing, and bioinformatic pipelines for consensus sequences, host genomics, and intrahost variability. Laboratories that run clinical assays are CLIA certified.
Additionally, the Laboratories prepare and store biospecimens such as plasma, serum, CSF, PBMC, respiratory swabs, and biopsies. Samples from an extensive biorepository containing more than 3 million specimens dating back to the early 1980s that can be requested to perform retrospective and prospective studies on such diseases as HIV, HCV, influenza, and SARS-CoV-2.
In addition to Laboratory services in Frederick, the Laboratories support the DCR Global Research Projects (Special Projects). The Laboratories work with the government DCR/CCRB Laboratory Lead to support development and maintenance of high-quality clinical laboratories and scientific capacity in the Special Projects. They also assist with rapid mobilization during emergency responses.
For more information about DCR Laboratories, please email DCRLaboratory@mail.nih.gov.