4.5 Article

Effect of Gamma Irradiation on the Antibody Response Measured in Human Serum from Subjects Vaccinated with Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine

Journal

AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
Volume 101, Issue 1, Pages 207-213

Publisher

AMER SOC TROP MED & HYGIENE
DOI: 10.4269/ajtmh.19-0076

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Funding

  1. Department of Health and Human Services, Office of the Assistant Secretary of Preparedness and Response, Biomedical Advanced Research and Development Authority [HHSO10201500002C]
  2. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ

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rVSV Delta G-ZEBOV-GP vaccine is a live recombinant (r) vesicular stomatitis virus (VSV), where the VSV G protein is replaced with the Zaire Ebola virus (ZEBOV) glycoprotein (GP). For vaccine immunogenicity testing, clinical trial sera collected during an active ZEBOV outbreak underwent gamma irradiation (GI) before testing in biosafety level 2 laboratories to inactivate possible wild-type ZEBOV. Before irradiating pivotal trial samples, two independent studies evaluated the impact of GI (50 kGy) on binding ZEBOV-GP (ELISA) antibodies against rVSV Delta G-ZEBOV-GP, using sera from a North American phase 1 study. Gamma irradiation was associated with slightly higher antibody concentrations in pre-vaccination samples and slightly lower concentrations postvaccination. Results indicate that GI is a viable method for treating samples from regions where filoviruses are endemic, with minor effects on antibody titers. The impact of GI on immunogenicity analyses should be considered when interpreting data from irradiated specimens.

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