NCT07254728

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 Years Old and Their Breast-feeding Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Vaxart · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity of oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and its association with the immunogenicity response in breastmilk.

Conditions

• Norovirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	VXA-G1.1-NN	Oral tablets.
BIOLOGICAL	VXA-G2.4-NS	Oral tablets.
BIOLOGICAL	Placebo Tablets	Oral tablets.

Timeline

• Start date: 2023-10-27
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2025-11-28
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

5 sites across 1 country: South Africa

Regulatory

• FDA-regulated drug study