InfluenzaPhase 1/2NCT00197301
Liposomal Based Intranasal Influenza Vaccine:Safety and Efficacy
A Phase 1/2 study testing Vaccination in people with Influenza, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
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.
- Conditions
- Influenza
- Being tested
- Vaccination
- Keywords
- Intranasal vaccination, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection
Secondary outcomes (1)
Antibody levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Arie Ben Yehuda, M.D., Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197301
- Sponsor's protocol ID
- 16-05.08.05-HMO-CTIL
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Examine the Safety and Efficacy of a Novel Liposomal Based Intranasal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT00197301
- Acronym / sponsor ID
- 16-05.08.05-HMO-CTIL
- Conditions
- Influenza
- Keywords
- Intranasal vaccination, Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Apr 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccination | Biological | – |
Primary outcome
Seroprotection
1 secondary outcome
Antibody levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arie Ben Yehuda, M.D. study director
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaccination in people with Influenza, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprotection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.