Title of Collaborative Activity: |
Development of Filovirus BSL-D Neutralization and Enzyme-Linked Immunosorbent Assay (ELISA) Tests for Licensing of Vaccines and Immunoglobulin Preparations |
Description of Collaborative Activity: |
NIH has been working with the Food and Drug Administration (FDA) to develop standardized BSL2 neutralization and enzyme-linked immunosorbent assay (ELISA) tests to evaluate nonhuman primate immune responses to filoviruses. These standardized tests can be used by all filovirus vaccine developers to assess these surrogate markers for vaccine efficacy in preclinical studies and for studies performed to obtain FDA licensure of a vaccine under the Animal Rule. |
Type of Collaborative Activity: |
Research Initiative
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Year the Collaborative Activity Originated: |
2013 |
NIH Participating Institutes/Centers/Office of the Director: |
NIAID |
HHS Agency Collaborators on this Activity: |
FDA |
