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Effects of Gamma Irradiation of Human Serum Samples from rVSVΔG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays

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  • 1 Merck & Co., Inc., Kenilworth, New Jersey;
  • | 2 Crozet BioPharma, Devens, Massachusetts

ABSTRACT

Gamma irradiation (GI) is included in the CDC guidance on inactivation procedures to render a group of select agents and toxins nonviable. The Ebola virus falls within this group because it potentially poses a severe threat to public health and safety. To evaluate the impact of GI at a target dose of 50 kGy on neutralizing antibody titers induced by the rVSVΔG-ZEBOV-GP vaccine (V920), we constructed a panel of 48 paired human serum samples (GI-treated versus non–GI-treated) from healthy participants selected from a phase 3 study of V920 (study V920-012; NCT02503202). Neutralizing antibody titers were determined using a validated plaque-reduction neutralization test. GI of sera from V920 recipients was associated with approximately 20% reduction in postvaccination neutralizing antibody titers. GI was not associated with any change in pre-vaccination neutralizing antibody titers.

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Author Notes

Address correspondence to Jakub K. Simon, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033. E-mail: jakub.simon@merck.com

Disclosure: R. J. G.-K., J. A., S. D., and J. K. S. are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, and may own stock/stock options in Merck & Co., Inc., Kenilworth, NJ. R. N. has received personal fees from New Link Genetics as a consultant.

Financial support: This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ. This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract no. HHSO100201500002C. Medical writing assistance, under the direction of the authors, was provided by Adele Blair, of CMC AFFINITY, McCann Health Medical Communications, in accordance with Good Publication Practice (GPP3) guidelines. This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ.

Authors’ addresses: Rebecca J. Grant-Klein, Joseph Antonello, Sheri Dubey, and Jakub K. Simon, Merck & Co., Inc., Kenilworth, NJ, E-mails: rebecca.klein1@merck.com, joseph_antonello@merck.com, sheri_dubey@merck.com, and jakub.simon@merck.com. Rick Nichols, Crozet BioPharma, Devens, MA, E-mail: rick.nichols@crozetbiopharma.com.

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