Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Phase 1

Completed

• Conditions: Influenza

• Registration Number: NCT00197301
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Influnza vaccination is highly recommended over the age of 50,but is only 50% efficatious among the elderly. A Vaccine given as a nasal spray may improve compliance and local immunity.Liposomes are lipid particles that may serve as carriers for the vaccine and together they enhance the local immune response in mice when given as nasal spray.This study aims to examine the safety and nasal and humoral responses to the nasal vaccine compared to the commercial muscular vaccine.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Start: 2005-10
• Study Completion: 2006-04
• Last Update Submitted: 2006-11-06
• Last Update Posted: 2006-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Healthy young(20-45years old) and elderly(65-95 years old) volunteers -

Exclusion Criteria

Known allergy to eggs and to the flu vaccine, pregnant and breast feeding women, chronic viral carriers, recently hospitalized persons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroprotection

Secondary Outcome Measures

Name	Time	Method
Antibody levels

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel