Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 66
• Participant gender: Both

Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vaxart
• Treatments: Vaccines
• Last Updated: 2016-08-15

Criteria

Inclusion Criteria:

1. Male or female volunteers aged 18 - 49 years, inclusive

2. Able to give written informed consent

3. Healthy (no clinically significant health concerns)

4. Safety laboratory values within the following range criteria normal range

5. Body mass index between 17 and 35 at screening

Exclusion Criteria:

1. Receipt of any investigational norovirus vaccine within two years prior to study

2. Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination

3. Administration of any licensed vaccine within 30 days prior to study

4. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline

5. History of drug, alcohol or chemical abuse within 1 year prior to vaccination

6. Presence of a fever ≥ 38oC measured orally at baseline

7. Stool sample with occult blood at screening -