Prospects and Challenges in the Development of a Norovirus Vaccine

Nicolas W. Cortes-Penfield, Sasirekha Ramani, Mary K. Estes, Robert L. Atmar

Research output: Contribution to journalReview articlepeer-review

80 Scopus citations


Purpose Norovirus is the leading cause of acute epidemic gastroenteritis among children under the age of 5 years and adults in the United States and in adults worldwide, accounting for an estimated 20% of episodes of acute gastroenteritis across all ages. No effective vaccine is presently available. This article provides an overview of the current state of norovirus vaccine development, emphasizing barriers and challenges in the development of an effective vaccine, correlates of protection used to assess vaccine efficacy, and the results of clinical trials of the major candidate vaccines. Methods We performed an unstructured literature review of published articles listed in PubMed in the field of norovirus vaccine development, with an emphasis on studies in humans. Findings Two candidate vaccines have reached clinical trials, and a number of other candidates are in the preclinical stages of development. Multivalent vaccination may be effective in inducing broadly neutralizing antibodies protective against challenge with novel and heterologous norovirus strains. Most identified correlates of protection have not been validated in large-scale challenge studies, nor have the degrees to which these correlates covary been assessed. Implications Immune correlates of protection against norovirus infection need to be further developed to facilitate additional studies of the tolerability and efficacy of candidate norovirus vaccines in humans.

Original languageEnglish (US)
Pages (from-to)1537-1549
Number of pages13
JournalClinical Therapeutics
Issue number8
StatePublished - Aug 2017
Externally publishedYes


  • acute gastroenteritis
  • calicivirus
  • norovirus
  • prevention
  • vaccine

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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