Establishing a correlate of protection as a surrogate endpoint for rotavirus vaccines could enable predictions of vaccine efficacy and facilitate a more rapid regulatory pathway for new vaccines.
Can correlates of protection be used as surrogate endpoints for the assessment of new rotavirus vaccines?
Identifying a suitable correlate of protection for rotavirus vaccines could serve as a surrogate endpoint, facilitating faster development and regulatory approval of new vaccines without requiring massive clinical endpoint trials.
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.
Ángel et al. (Sat,) conducted a review in Rotavirus infection. Rotavirus vaccines was evaluated. Establishing a correlate of protection as a surrogate endpoint for rotavirus vaccines could enable predictions of vaccine efficacy and facilitate a more rapid regulatory pathway for new vaccines.
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