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Clinical Trial Summary

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)


Clinical Trial Description

A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 2 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old). Subjects will we randomized in the study utilizing an age and dose escalation schedule. A Safety Monitoring Committee will provide oversight of the trial throughout the duration of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04854746
Study type Interventional
Source Vaxart
Contact Shaily J Garg
Phone 650-521-4496
Email [email protected]
Status Recruiting
Phase Phase 1
Start date April 26, 2021
Completion date June 1, 2022

See also
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Completed NCT01435811 - Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1) Phase 1
Recruiting NCT04875676 - Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines Phase 1/Phase 2