Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197301

Enrollment

200

Registered

2005-09-20

Start date

2005-10-31

Completion date

2006-04-30

Last updated

2006-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Intranasal vaccination, Influenza

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.

Interventions

BIOLOGICALVaccination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 95 Years

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 \-

Design outcomes

Primary

Measure	Time frame
Seroprotection	—

Secondary

Measure	Time frame
Antibody levels	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026