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Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

This study has been completed.
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 12, 2005
Last updated: November 6, 2006
Last verified: September 2005
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 Biological: Vaccination Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Seroprotection

Secondary Outcome Measures:
  • Antibody levels

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: April 2006

Ages Eligible for Study:   20 Years to 95 Years   (Adult, Senior)
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00197301

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Study Director: Arie Ben Yehuda, M.D. Hadassah Medical Organization
  More Information Identifier: NCT00197301     History of Changes
Other Study ID Numbers: 16-05.08.05-HMO-CTIL
Study First Received: September 12, 2005
Last Updated: November 6, 2006

Keywords provided by Hadassah Medical Organization:
Intranasal vaccination, Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017