Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

Phase 2CompletedNCT00197301

Hadassah Medical Organization200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Influenza

Interventions

VaccinationBIOLOGICAL

Eligibility

Sex: ALLMin age: 20 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

Seroprotection

Secondary Outcomes

Antibody levels

Data from ClinicalTrials.gov

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