Clinical Trial: Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

This study is not yet open for patient recruitment.
Verified by Hadassah Medical Organization September 2005

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00197301

Purpose

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 Intervention Phase
Influenza
 Vaccine: Vaccination
Phase I
Phase II

MedlinePlus related topics:  Flu

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine

Further Study Details: 
Primary Outcomes: Seroprotection
Secondary Outcomes: Antibody levels
Expected Total Enrollment:  200

Study start: October 2005;  Expected completion: June 2006
Last follow-up: April 2006;  Data entry closure: April 2006

Eligibility

Ages Eligible for Study:  20 Years   -   95 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00197301

Arik Tzukert, DMD      0097226776095 
Hadas Lemberg, Ph.D      0097226777572 

Israel
      Hadassah Medical Organization, Jerusalem,  91120,  Israel
Arik Tzukert, DMD  0097226776095 
Arie Ben Yehuda, MD,  Principal Investigator

Study chairs or principal investigators

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

More Information

Study ID Numbers:  16-05.08.05
Last Updated:  September 19, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00197301
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2005-09-20

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