NCT05805618

Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects

A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects Aged 18-59 Years

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.

Detailed description

It is planned to enroll healthy subjects and adopt a 3-dose vaccination schedule (day 0 to day 56) of intramuscular injections of study vaccines in the deltoid muscle of the upper arm of subjects on day 0, day 28 and day 56, respectively. The subjects will sequentially enter into the low and high dose groups by stages, with approximately 30 subjects in each group (test group:control group = 2:1) and approximately up to 60 subjects in total. At least half of the subjects are Chinese in the two cohorts respectively

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Norovirus Hexavalent Vaccine	To prevent acute gastroenteritis caused by norovirus of genotypes GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17
OTHER	Matching Placebo	matching placebo for Recombinant Norovirus Hexavalent Vaccine / KH002

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-04-10
• Last updated: 2023-11-28