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Phase 1 Norwalk Vaccine Study

NCT00806962 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-05-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Adjuvant/Excipients

intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart

DEVICE

placebo

intranasal, puff of air, 2 doses, 21 days apart

BIOLOGICAL

Norwalk VLP Vaccine

intranasal, 50mcg, 2 doses--21 days apart

BIOLOGICAL

Norwalk VLP Vaccine

Intranasal, 100 mcg, 2 doses, 21 days apart

Sponsors & Collaborators

  • LigoCyte Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John J Treanor, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00806962 on ClinicalTrials.gov