Phase 1 Norwalk Vaccine Study

Norovirus Clinical Trial

Official title: Randomized Double-Blind Placebo-Controlled Phase 1, Safety and Immunogenicity Study of Two Dosages of Intranasal Norwalk Virus-like Particle Vaccine ( Norwalk VLP Antigen, MPL®, Chitosan, Mannitol, and Sucrose) Compared to Adjuvant/Excipients (MPL®, Chitosan, Mannitol, and Sucrose) and to Placebo (Empty Device

Status Completed

Clinical Trial Summary

Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls

Primary Objective:

• Safety as determined by occurrence of local intranasal symptoms or other symptoms as reported by a self-administered memory aid for 7 days after each vaccination and hematology, blood chemistry and physical examinations performed by the clinical research staff

• Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new medical conditions for 180 days following the last study vaccinations (Day 201).

Secondary Objectives

Evaluations of immunogenicity as determined by:

• Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA

• Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)

• Presence of antigen specific memory B-cell response

Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific cell-mediated immune (CMI) responses

Study Hypothesis:

The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events compared to placebo but similar incidence of other adverse events.

Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50 µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to adjuvant/excipients and to placebo.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Norovirus

• NCT number: NCT00806962
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Completion date: October 2009