FDA Studying Highly Dangerous Viruses to Inform Development of Vaccines


Ebola at the top of the list for research

In order to address the challenges of characterizing the durability of the human immune response to infection with Ebola virus, the U.S. Food and Drug Administration is supporting a study of the immune response in Ebola Virus disease and Marburg Virus disease survivors as well as in individuals vaccinated with investigational Ebola vaccines. This study will help the evaluation of the performance of existing medical countermeasures (MCMs) while also supporting the development of next-generation MCMs.

In collaboration with the Congolese Institut National de la Recherche Biomédicale (National Institute for Biomedical Research), the University of California at Los Angeles (UCLA) will expand a biobank of plasma and peripheral blood mononuclear cell (PBMC) samples to help support the development of MCMs against Ebola and Marburg viruses. 

These biobanks will be used in conjunction with Stanford University and the University of Hawaii, as well as the National Institutes of Health Integrated Research Facility to characterize the natural immunity of survivors as well as the correlation to vaccine-induced immunity.

Here are four projected program outcomes from the FDA:

  1. Comprehensive evaluation of the anti-GP antibody response of the rVSV-ZEBOV vaccine via FANG and FRNA assay of vaccines and control populations.
  2. Identification of potential correlates of vaccine-induced immunity via characterization of immune profiles of vaccinated populations (using sub-cohorts from Objective 1) via Western blot, GeneXpert, Lehrer multiplex pan-filovirus assay on vaccine sub-cohorts.
  3. Characterization of long-term (life course) natural immunity in EVD survivors via CyTOF, Lehrer multiplex pan-filovirus assay, and Elispot assay of EVD survivors.
  4. Characterization of correlates of natural immunity of MVD survivors via Lehrer multiplex pan-filovirus assay, CyTOF mass cytometry and assessment of neutralizing antibodies via PRNT and FRNA assays.

The project, funded through the MCMi Regulatory Science Extramural Research program, is planned to run through September 2020.


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