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Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines

NCT03897309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-09-21

No results posted yet for this study

Summary

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.

Conditions

  • Norovirus Infection

Interventions

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

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • Mary Beth Manning, MD · Rapid Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2021-01-15
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897309 on ClinicalTrials.gov