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

Completed · Phase 1 · Has a placebo group

Conditions studied: Norovirus Gastroenteritis

In brief

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

Key facts

Study ID

NCT02868073

Run by

Vaxart

People needed

66

Starts

2016-07-29

Expected to finish

2017-10-01

Last updated by the study team

2018-05-31

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female volunteers aged 18 - 49 years, inclusive
• Able to give written informed consent
• Healthy (no clinically significant health concerns)
• Safety laboratory values within the following range criteria normal range
• Body mass index between 17 and 35 at screening

You may not qualify if…

• Receipt of any investigational norovirus vaccine within two years prior to study
• Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
• Administration of any licensed vaccine within 30 days prior to study
• 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
• History of drug, alcohol or chemical abuse within 1 year prior to vaccination
• Presence of a fever ≥ 38oC measured orally at baseline
• Stool sample with occult blood at screening -

Where it is running

• Celerion, Inc. — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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