InfluenzaPhase 1NCT00375206
A Safety and Immunology Study of a DNA Trivalent Influenza Vaccine
A Phase 1 study testing Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012) in people with Influenza, run by PowderMed at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
- Type of treatment
- Vaccines
- How many people
- 189 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2006to Jan 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers (women must be of non child-bearing potential)
- Provided written informed consent
Who cannot join
- No significant concomitant illness
- No allergy to gold
- No immunosuppression due to disease or treatment
- No previous flu vaccination in 2005 or 2006
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quintiles Lenexa (QLX)
Lenexa, Kansas, 66219
Biokinetic
Springfield, Missouri, 65802
About this study
Official title: A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.
Read the detailed description
Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.
- Conditions
- Influenza
- Being tested
- Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)
- Keywords
- PowderMed, DNA vaccine, 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.
Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and local reactogenicity - AEs and laboratory parameters
Secondary outcomes (1)
Immunogenicity of the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Study completionJan 2007
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.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 189 participants
Sponsor and investigators
- Lead sponsor
- PowderMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Leese, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375206
- Sponsor's protocol ID
- PM FLS-001
- Status last verified
- Jan 2007
- First submitted
- 11 Sep 2006
- Last updated
- 29 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess Safety, Tolerability and Immunogenicity of a Trivalent Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Subjects
- ClinicalTrials.gov ID
- NCT00375206
- Acronym / sponsor ID
- PM FLS-001
- Conditions
- Influenza
- Keywords
- PowderMed, DNA vaccine, influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants
- Lead sponsor
- PowderMedIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Jan 2007
- First posted
- 12 Sep 2006 (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.
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.
Detailed description
Influenza is a contagious disease of the upper airways and the lungs. It rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. Each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. Current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. This study is part of the clinical development of a particle mediated epidermal delivery (PMED) trivalent DNA vaccine for the prevention of influenza.This study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult volunteers (women must be of non child-bearing potential)
- Provided written informed consent
Key exclusion criteria (4 listed)
- No significant concomitant illness
- No allergy to gold
- No immunosuppression due to disease or treatment
- No previous flu vaccination in 2005 or 2006
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 |
|---|---|---|
| Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012) | Biological | – |
Primary outcome
Safety, tolerability and local reactogenicity - AEs and laboratory parameters
1 secondary outcome
Immunogenicity of the vaccine
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 29 Jan 2007.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Philip Leese, MD principal investigator
Quintiles, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trivalent DNA Vaccine (PIA0601) with or without DEI-LT (pPJV2012) in people with Influenza, run by PowderMed at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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 29 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
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?
Safety, tolerability and local reactogenicity - AEs and laboratory parameters. 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 29 Jan 2007.