common.study.topics.clinical

Oral Norovirus Vaccine Study on Healthy Subjects

common.study.values.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.

common.study.values.location

participant.ui.study.affiliations-map.online-study.header-virtual

participant.ui.study.affiliations-map.online-study.text

participant.ui.study.affiliations-map.legend.locations participant.ui.study.affiliations-map.legend.selected

common.study.values.methods

No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

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

participant.views.study.view.additional

participant.views.study.view.scientific-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

common.study.values.clinical-trial-id

NCT03897309

participant.views.study.view.id

e5yEAe