Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Completed
• CT.gov ID: NCT00197301
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 33.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Vaccination	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
• Study Start Date: Oct 1, 2005
• Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. Seroprotection []

Secondary Outcome Measures

1. Antibody levels []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Study Director: Arie Ben Yehuda, M.D., Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00197301
• Other Study ID Numbers: 16-05.08.05-HMO-CTIL
• First Posted: Sep 20, 2005
• Last Update Posted: Nov 7, 2006
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Intranasal vaccination, Influenza
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Nov 7, 2006