Sample Collection and General Screening Protocols

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

Abstract

The purpose of this Vaccine Research Center (VRC) Clinical Trials Program (CTP) project is to screen volunteers for protocols that involve the administration of investigational agents and to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or other body fluids, and in some circumstances perform radiographic imaging and clinical evaluations, to support laboratory research studies and to validate research assays used in evaluation of clinical trials immunogenicity results. These samples and data are used by laboratory researchers in their work on the development of vaccines and monoclonal antibodies targeting HIV and other emerging infectious diseases, to study the correlates of immunity related to infectious diseases, and in laboratory work related to the development and/or validation of immunological assays. To carry out research studies, it is sometimes necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy. These blood components can be safely obtained using apheresis procedures, which are performed in the NIH Clinical Center Department of Transfusion Medicine. During FY23, healthy volunteers have been enrolled in the VRC/CTP screening protocol (VRC 500) to assess healthy volunteers for eligibility in the following trials: a next-generation HIV monoclonal antibody targeting the HIV envelope CD4 binding site; a novel mRNA Nipah virus vaccine; and a novel hexavalent mosaic nanoparticle influenza vaccine. In addition, a new effort to collect samples by fine-needle aspiration of an axillary lymph node after influenza vaccination was implemented under the specimen collection protocol VRC 900 with the goal of understanding evolution of the B cell response after vaccination.