Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial.

ABSTRACT:

Background

Noroviruses are the leading cause of epidemic acute gastroenteritis and foodborne diarrheal disease in humans. However, there are no approved vaccines for noroviruses. Potential correlates of protection identified through human challenge studies include mucosal IgA, memory B cells, and serum-blocking antibody titers (BT50).

Methods

We conducted a single-site, randomized, double-blind, placebo-controlled clinical trial of an oral norovirus vaccine to determine safety and immunogenicity. This tablet vaccine is comprised of a nonreplicating adenovirus-based vector expressing the VP1 gene from the GI.1 norovirus strain and a double-stranded RNA adjuvant. Sixty-six adult subjects meeting inclusion/exclusion criteria were randomized 2:1 to receive a single vaccine dose

SUBMITTER: Kim L 

PROVIDER: S-EPMC6124525 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature