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 Health Stable Older Adult Volunteers 55-80 Years of Age
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Norovirus Infections
- Sponsor
- Vaxart
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Rate of Solicited Adverse Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)
Detailed 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 3 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Solicited Adverse Events
Time Frame: Day 1 (Vaccination) to 7 days post vaccination
Safety
Rate of Unsolicited Adverse Events
Time Frame: Day 1 (Vaccination) to 28 days post vaccination
Safety
Secondary Outcomes
- VP1 specific IgA ASC(Day 1 (Vaccination) to 7 days post vaccination)
- Norovirus GI.1 histo-blood group antigen GBGA blocking antibodies (BT50)(Day 1 (Vaccination) to 7 days post vaccination)
- VP1 specific serum IgG(Day 1 (Vaccination) to 7 days post vaccination)