NCT06944717

A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old

A Phase 1, Single Center, Open Label, Single Dose, Dose Escalation Study to Determine the Safety and Immunogenicity of a Novel Bivalent Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Volunteers Aged ≥ 18 Years and ≤ 80 Years Old

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vaxart · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.

Conditions

• Norovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	VXA-G1.1-NN	Legacy vaccine, administered orally.
BIOLOGICAL	VXA-G2.4-NS	Legacy vaccine, administered orally.
BIOLOGICAL	VXA G1.1 NN-T	Next generation vaccine, administered orally.
BIOLOGICAL	VXA G2.4 NS-T	Next generation vaccine, administered orally.

Timeline

• Start date: 2025-03-03
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-04-25
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study