Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 5:15 PM
Study NCT ID:
NCT05626803
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Sponsor:
Vaxart
Organization:
Study Overview
Official Title:
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-ranging Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccine Administered Orally to Healthy Volunteers Aged Greater Than or Equal to 18 Years and Less Than or Equal to 80 Years Old.
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.
Detailed Description:
Norovirus infections are a leading cause of sporadic and epidemic gastroenteritis across all age groups worldwide. This study is designed as a standard double-blind placebo-controlled single administration, dose ranging study to evaluate the safety and immunogenicity of 2 different doses of VXA-GII.4-NS plus VXA-G1.1-NN (high and medium dose administered orally for the prevention of Norovirus infection), compared with a placebo.
This study will enroll a total of 135 subjects with10 sentinel subjects in an open label period (dosing staggered to not-more-than 2 subjects per 24 hours) and randomize 125 subjects in three arms.
The first 10 sentinel subjects will receive the open label high dose of active vaccine. If no dose-related toxicities are observed, and upon the recommendation of the SMC following review of safety data, subjects will be randomized in a 2:2:1 ratio to one of the 3 study arms to receive active vaccine or placebo. After vaccination on Day 1, the study will include an Active Study Period that runs through 4 weeks after administration (Day 29), and a Follow-up Period of one year for safety and duration of immune response.
This study will enroll a total of 135 subjects with10 sentinel subjects in an open label period (dosing staggered to not-more-than 2 subjects per 24 hours) and randomize 125 subjects in three arms.
The first 10 sentinel subjects will receive the open label high dose of active vaccine. If no dose-related toxicities are observed, and upon the recommendation of the SMC following review of safety data, subjects will be randomized in a 2:2:1 ratio to one of the 3 study arms to receive active vaccine or placebo. After vaccination on Day 1, the study will include an Active Study Period that runs through 4 weeks after administration (Day 29), and a Follow-up Period of one year for safety and duration of immune response.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: