Trial Profile
A Phase 2b Double-Blinded, Randomized, Placebo-Controlled, Human Norovirus GI.1 (Norwalk Virus Inoculum) Challenge Study Following Administration of an Oral, Single-dose Norovirus Vaccine Expressing GI.1 VP1 and dsRNA Adjuvant to Protect Against Norovirus Gastroenteritis (NVG) in Healthy Adult Volunteers
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 23 Jan 2024
Price :
$35
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At a glance
- Drugs VXA G1.1 NN (Primary)
- Indications Norovirus infections
- Focus Therapeutic Use
- Sponsors Vaxart
- 17 Jan 2024 Status changed from active, no longer recruiting to completed.
- 06 Sep 2023 According to a Vaxart media release, Vaxart is currently conducting additional analyses of the data from this challenge study and its prior norovirus trials with the objectives of defining the timing of a larger phase 2b study, and identifying ways to reduce the size and duration of a subsequent Phase 3 registration study.
- 06 Sep 2023 Primary endpoint (norovirus-specific serum IgA (GMFR 7.14) and IgG (GMFR 4.64) in the vaccinated cohort compared with placebo from baseline to Day 29 post-vaccination) has been met as per Vaxart Media Release