The Centers for Disease Control and Prevention (CDC) intends to issue a Request for Proposal (RFP) to support the National Center for Immunizations and Respiratory Diseases (NCIRD) Influenza Division.
The NCIRD Influenza Division is responsible for the detection and characterization of influenza viruses for the purposes of disease surveillance and vaccine strain selection. Tests that measure immunity to influenza and characterize the antigenicity of the virus are critical for detecting influenza infection, understanding the mode of transmission, and selecting viruses to be included in the annual vaccine.
New, High throughput and automated assays are necessary to keep up the pace with the testing demands of global influenza surveillance. Development of new assays to support surveillance was initiated several years ago, but updates are required to ensure that the assays can detect newly emerging influenza viruses and to keep up with new technologies.
The purpose of this activity in the contract is to develop new technologies to improve upon the traditional hemagglutination inhibition (HI) assay to make the assay mobile, high-throughput, standardized, and automated.
Data obtained from the assay is essential for World Health Organization (WHO) and Food and Drug Administration (FDA) to make influenza vaccine recommendations. However, this assay is difficult to make mobile, standardize, and automate because it relies on the use of red blood cells, antisera dilutions and humans to read the test results.
The Influenza Division is also responsible for influenza outbreak investigations, seasonal vaccine strain selections, and vaccine effectiveness studies. There are often situations where the influenza laboratories are not capable of completing research projects due to a significant outbreak or emergence of a new virus subtype thus requiring a shift of testing priorities.
In these cases, HI assays, microneutralization (MN) assays, Sanger gene sequencing, Reverse Transcription Polymerase Chain Reaction (RT-PCR) testing for vaccine strain selection and effectiveness studies need to be outsourced to publish study results in a timely manner.
Activities supporting vaccine effectiveness and vaccine development, such as avidity antibody assays, Antibody-dependent cell-mediated cytotoxicity (ADCC) and related assays, and B-cell sequencing activities are necessary to support the vaccine development and efficacy determination activities of the entire influenza surveillance process. These activities in the contract will also serve as a vehicle for influenza surge testing when CDC laboratories are overwhelmed with other testing demands.
As part of the U.S. pandemic preparedness and response, it is important to assess influenza vaccine potency and efficacy with the goals of supporting the development, approval, and production of influenza vaccines. The contract will support these activities with the development of an enzyme-linked immunoassay (or equivalent assay) to assess influenza vaccine potency and efficacy.
The contract also calls for activities to acquire left over sera from various diagnostic laboratories across the U.S. to characterize seroprevalences against emerging novel influenza viruses from various age groups.
Further details are available via Solicitation Number: 2015-N-17131. The official RFP is expected to be released on or about June 15, 2015.