Influenza (Pandemic)Phase 1NCT00347529
Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
A Phase 1 study testing pPML7789 with and without pPJV2012 administered by PMED in people with Influenza (Pandemic), run by PowderMed at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza (Pandemic)
- What is being tested?
- pPML7789 with and without pPJV2012 administered by PMED
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 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 adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent
- -
Who cannot join
- No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys Research Drug Unit, Quintiles Ltd.
London, SE1 1YR
About this study
Official title: A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu
Read the detailed description
Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28
- Conditions
- Influenza (Pandemic)
- Being tested
- pPML7789 with and without pPJV2012 administered by PMED
- Keywords
- DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pPML7789 with and without pPJV2012 administered by PMEDBiological
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 posted4 Jul 2006 (estimated)
- Study startAug 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 Influenza (Pandemic)Studies 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
- 75 participants
Sponsor and investigators
- Lead sponsor
- PowderMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tim Mant, BSc, FRCP, FFPM, Principal investigator, Guys Research Drug Unit, Quintiles UK Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347529
- Sponsor's protocol ID
- PM FLP-001
- Status last verified
- Jan 2007
- First submitted
- 30 Jun 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 Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults
- ClinicalTrials.gov ID
- NCT00347529
- Acronym / sponsor ID
- PM FLP-001
- Conditions
- Influenza (Pandemic)
- Keywords
- DNA vaccine, influenza, immunogenicity, tolerability, PMED, pandemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- PowderMedIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Jan 2007
- First posted
- 4 Jul 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, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu
Detailed description
Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28
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 adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent
- -
Key exclusion criteria (1 listed)
- No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment
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 |
|---|---|---|
| pPML7789 with and without pPJV2012 administered by PMED | 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.
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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.
Tim Mant, BSc, FRCP, FFPM principal investigator
Guys Research Drug Unit, Quintiles UK Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pPML7789 with and without pPJV2012 administered by PMED in people with Influenza (Pandemic), run by PowderMed at 1 site in United Kingdom.
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 1 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 1 site in United Kingdom. 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.