Correlates of protection for rotavirus vaccines: Possible alternative trial endpoints, opportunities, and challenges

Juana Angel*, A. Duncan Steele, Manuel A. Franco

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

40 Citations (Scopus)

Abstract

Rotavirus (RV) is a major vaccine-preventable killer of young children worldwide. Two RV vaccines are globally commercially available and other vaccines are in different stages of development. Due to the absence of a suitable correlate of protection (CoP), all RV vaccine efficacy trials have had clinical endpoints. These trials represent an important challenge since RV vaccines have to be introduced in many different settings, placebo-controlled studies are unethical due to the availability of licensed vaccines, and comparator assessments for new vaccines with clinical endpoints are very large, complex, and expensive to conduct. A CoP as a surrogate endpoint would allow predictions of vaccine efficacy for new RV vaccines and enable a regulatory pathway, contributing to the more rapid development of new RV vaccines. The goal of this review is to summarize experiences from RV natural infection and vaccine studies to evaluate potential CoP for use as surrogate endpoints for assessment of new RV vaccines, and to explore challenges and opportunities in the field.

Original languageEnglish
Pages (from-to)3659-3671
Number of pages13
JournalHuman Vaccines and Immunotherapeutics
Volume10
Issue number12
DOIs
Publication statusPublished - 1 Dec 2014
Externally publishedYes

Keywords

  • Correlates of protection
  • IgA
  • Mucosal
  • Rotavirus
  • Vaccines

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