Clinical Trial

Oral Norovirus Vaccine Study on Healthy Subjects

Study Description

Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent Dosing in Healthy Adult Volunteers. The study consists of 2 parts: Part 1 is the double-blinded portion where subjects will be randomized to one of two monovalent vaccine groups, bivalent vaccine group or placebo. Subjects will be followed for ~4 weeks post vaccination for safety and immunogenicity. Part 2 will consist of an open label booster vaccination for the bivalent treatment group ~4 months post initial vaccination. All subjects will be followed for long term safety for 1 year post initial vaccination.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - VXA-G1.1-NN

Monovalent GI.1 tableted vaccine

Biological - VXA-G2.4-NS

Monovalent GII.4 tableted vaccine

Biological - Placebo Tablets

Tablets matching in number and appearance to active vaccine doses

Additional Information

Official Study Title

A Ph 1b, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 With Monovalent or Bivalent Dosing

Clinical Trial ID

NCT03897309

ParticipAid ID

e5yEAe