CompletedPhase 1

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

United States66 participantsStarted 2016-07-29

Plain-language 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

Who can participate

Age range18 Years – 49 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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 -

What they're measuring

Incidence of Treatment Emergent Solicited and Unsolicited Adverse Events

Timeframe: Day 1 thru Day 28

Trial details

NCT IDNCT02868073

SponsorVaxart

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-10-05

View on ClinicalTrials.gov More Norovirus Gastroenteritis trials