Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)
Completed · Phase 1 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus (RSV)
In brief
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers
Key facts
- Study ID
- NCT02830932
- Run by
- Vaxart
- People needed
- 66
- Starts
- 2016-06-22
- Expected to finish
- 2017-09-20
- Last updated by the study team
- 2018-08-16
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 RSV 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
- Optimal Research — Melbourne, Florida, United States
Full record on ClinicalTrials.gov
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