InfluenzaPhase 1NCT00709800
Pandemic Influenza Plasmid DNA Vaccines (Needle)
A Phase 1 study testing VCL-IPT1, VCL-IPM1 and PBS in people with Influenza, run by Vical at 3 sites in United States.
Trial summary
The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VCL-IPT1, VCL-IPM1 and PBS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Sep 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years of age
- Able to provide informed consent and be followed for 6 months
Who cannot join
- No immunomodulatory therapy within the past 6 months
- No evidence of immunodeficiency or pregnancy
- No laboratory or evidence of clinically significant medical disease
- No history of previous pDNA immunization
- No influenza immunization within the past 30 days
- No blood donations within 30 days of screening visit
- No history of bleeding disorder
- No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines
Trial locations and contacts
3 sites in 1 country.
United States3 sites
SNBL
Baltimore, Maryland, 21201
Accelovance
San Diego, California, 92108
SUNY at Stonybrook, Stony Brook Medical Center
Stony Brook, New York, 11794-8153
About this study
Official title: A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines
The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.
- Conditions
- Influenza
- Being tested
- VCL-IPT1, VCL-IPM1, PBS
- Keywords
- Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCL-IPT1Biological
IM, 0.1 mg/mL, 2 injections, 0 and 21 days
VCL-IPT1Biological
IM, 0.5 mg/mL, 2 injections, 0 and 21 days
VCL-IPT1Biological
IM, 1 mg/mL, 2 injections, 0 and 21 days
VCL-IPM1Biological
IM, 1 mg/mL, 2 injections, 0 and 21 days
PBSBiological
Also called Phosphate Buffered Saline
IM, 1 mL, 2 injections, 0 and 21 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Not described Receives: Biological: VCL-IPT1 |
| 3 | Experimental | Not described Receives: Biological: VCL-IPT1 |
| 4 | Experimental | Not described Receives: Biological: VCL-IPM1 |
| 5 | Placebo comparator | Not described Receives: Biological: PBS |
| 1 | Experimental | Not described Receives: Biological: VCL-IPT1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects
Measured: 6 months
Secondary outcomes (1)
Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Don Guterwill, BS, MT, Study chair, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709800
- Sponsor's protocol ID
- IPT1-101
- Status last verified
- Feb 2009
- First submitted
- 1 Jul 2008
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines
- ClinicalTrials.gov ID
- NCT00709800
- Acronym / sponsor ID
- IPT1-101
- Conditions
- Influenza
- Keywords
- Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 3 Jul 2008 (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 trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Biological: VCL-IPT1 |
| 3 | Experimental | Biological: VCL-IPT1 |
| 4 | Experimental | Biological: VCL-IPM1 |
| 5 | Placebo comparator | Biological: PBS |
| 1 | Experimental | Biological: VCL-IPT1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 45 years of age
- Able to provide informed consent and be followed for 6 months
Key exclusion criteria (8 listed)
- No immunomodulatory therapy within the past 6 months
- No evidence of immunodeficiency or pregnancy
- No laboratory or evidence of clinically significant medical disease
- No history of previous pDNA immunization
- No influenza immunization within the past 30 days
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 |
|---|---|---|
| VCL-IPT1IM, 0.1 mg/mL, 2 injections, 0 and 21 days | Biological | 1 |
| VCL-IPT1IM, 0.5 mg/mL, 2 injections, 0 and 21 days | Biological | 2 |
| VCL-IPT1IM, 1 mg/mL, 2 injections, 0 and 21 days | Biological | 3 |
| VCL-IPM1IM, 1 mg/mL, 2 injections, 0 and 21 days | Biological | 4 |
| PBSAlso: Phosphate Buffered SalineIM, 1 mL, 2 injections, 0 and 21 days | Biological | 5 |
Primary outcome
Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects
Time frame: 6 months
1 secondary outcome
Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1
Time frame: 6 months
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 12 Feb 2009.
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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.
Don Guterwill, BS, MT study chair
Vical
3 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 VCL-IPT1, VCL-IPM1 and PBS in people with Influenza, run by Vical at 3 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 8 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 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects (time frame: 6 months). 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 12 Feb 2009.