Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines

Nicholas A. Lyons, Theodore J.D. Knight-Jones, Chris Bartels, David J. Paton, Giancarlo Ferrari, Meghan S. Vermillion, W Abdullah Brooks, Roxann Motroni, Elizabeth Parker, Melissa L. Hefferin Berquist, Keith J. Sumption, Eyal Klement

Research output: Contribution to journalArticle

Abstract

Vaccines are commonly used to control Foot-and-Mouth Disease (FMD) in endemic regions and form an important part of contingency plans for FMD-free countries. Conventional FMD vaccines have numerous limitations, and the U.S. government supports the development of next-generation vaccines. In the U.S., vaccine efficacy is typically demonstrated through experimental vaccination and challenge of animals using the World Organization for Animal Health (OIE) standards. Although conventional challenge and immunogenicity studies provide useful information, they have limitations and results do not always accurately predict field performance. Consequently, there is a need to test next-generation vaccines under field conditions to gain a better understanding of field performance to inform policy decisions and support their viability as a commercial product. In June 2017, an expert consultation was organised to discuss and define an optimal field study design for novel FMD vaccines. Cattle were the primary species considered, although parallel strategies for swine and small ruminants were also discussed. Many methodological and logistical considerations in the study design were identified, including: (1) study site selection and the importance of baseline studies to understand exposure risk, (2) ethics of using a placebo and assessing equivalence with conventional vaccines, (3) merits of using individual randomised versus cluster randomised trials, (4) preventive versus reactive vaccination, and (5) methods of randomisation and blinding. The proposed optimal study design was a multicentre (i.e. farm), three-arm, double-blind randomised controlled trial comparing groups receiving the novel vaccine to a conventional vaccine group and a placebo group. Large farms in areas of high exposure risk were identified as ideal study sites, and the primary study outcome was susceptibility to disease or infection, during a six-month observation period, following a single dose of vaccine. This report provides a summary of the important issues to consider when designing a field efficacy study in livestock and proposes a study design that could be utilised for novel FMD vaccines.

Original languageEnglish (US)
Pages (from-to)1007-1015
Number of pages9
JournalVaccine
Volume37
Issue number8
DOIs
StatePublished - Feb 14 2019

Fingerprint

Foot-and-Mouth Disease
foot-and-mouth disease
field experimentation
Vaccines
vaccines
experimental design
placebos
Vaccination
vaccination
Placebos
large farms
farm area
Disease Susceptibility
Ruminants
small ruminants
ethics
Livestock
Random Allocation
Ethics
animal health

Keywords

  • Foot-and-mouth disease
  • Livestock
  • Vaccine efficacy
  • Vaccine evaluation

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Lyons, N. A., Knight-Jones, T. J. D., Bartels, C., Paton, D. J., Ferrari, G., Vermillion, M. S., ... Klement, E. (2019). Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines. Vaccine, 37(8), 1007-1015. https://doi.org/10.1016/j.vaccine.2018.12.064

Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines. / Lyons, Nicholas A.; Knight-Jones, Theodore J.D.; Bartels, Chris; Paton, David J.; Ferrari, Giancarlo; Vermillion, Meghan S.; Brooks, W Abdullah; Motroni, Roxann; Parker, Elizabeth; Hefferin Berquist, Melissa L.; Sumption, Keith J.; Klement, Eyal.

In: Vaccine, Vol. 37, No. 8, 14.02.2019, p. 1007-1015.

Research output: Contribution to journalArticle

Lyons, NA, Knight-Jones, TJD, Bartels, C, Paton, DJ, Ferrari, G, Vermillion, MS, Brooks, WA, Motroni, R, Parker, E, Hefferin Berquist, ML, Sumption, KJ & Klement, E 2019, 'Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines', Vaccine, vol. 37, no. 8, pp. 1007-1015. https://doi.org/10.1016/j.vaccine.2018.12.064
Lyons NA, Knight-Jones TJD, Bartels C, Paton DJ, Ferrari G, Vermillion MS et al. Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines. Vaccine. 2019 Feb 14;37(8):1007-1015. https://doi.org/10.1016/j.vaccine.2018.12.064
Lyons, Nicholas A. ; Knight-Jones, Theodore J.D. ; Bartels, Chris ; Paton, David J. ; Ferrari, Giancarlo ; Vermillion, Meghan S. ; Brooks, W Abdullah ; Motroni, Roxann ; Parker, Elizabeth ; Hefferin Berquist, Melissa L. ; Sumption, Keith J. ; Klement, Eyal. / Considerations for design and implementation of vaccine field trials for novel foot-and-mouth disease vaccines. In: Vaccine. 2019 ; Vol. 37, No. 8. pp. 1007-1015.
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