InfluenzaPhase 1NCT00921973
Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults
A Phase 1 study testing VAX102 in people with Influenza, run by VaxInnate Corporation at 2 sites in United States.
Trial summary
The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VAX102
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Sep 2009
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 49 years inclusive
- Give written informed consent to participate in the study and adherence to all protocol requirements.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
- Females willing to practice birth control during the study.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Did not receive influenza vaccination (TIV) during the 2008-2009 influenza season.
Who cannot join
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
- History of cancer.
- History of impaired immunoresponsiveness, including diabetes.
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs or any components of the study vaccines.
- Received influenza vaccination during the 2008-2009 season
- History of systemic hypersensitivity reactions to egg proteins, or any other component of FLUVIRIN®, or life-threatening reactions to previous influenza vaccinations.
Show all 18Show fewer
- Has known history of Guillain-Barré Syndrome
- Presently receiving or history of receiving any medications or treatments that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable) in the past 6 months. Inhaled and topical corticosteroids will be allowed.
- Participated in a clinical trial or received or planned administration of an investigational compound within 30 days before receiving study vaccine and/or during the study through the Day 28 evaluation.
- Was vaccinated with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the study vaccine.
- History of anaphylactic type reaction to injected vaccines.
- History of drug or chemical abuse in the year before the study.
- Use of new prescription medications started within 7 days before study entry.
- Receipt of any blood products, including immunoglobulin, within 6 months before administration of study vaccine or anticipated receipt during the study period.
- Donation of blood or blood products within 8 weeks before study entry or at any time during the study.
- Has clinical signs of active infection and/or oral temperature of ≥ 38 (100.4 ºF). Study entry may be deferred for such individuals at the discretion of the investigator.
- Has evidence or history of (within the previous 12 months) drug or alcohol abuse.
- Any condition that, in the opinion of the investigator, might interfere with study objectives.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johnson County Clin Trials
Lenexa, Kansas, 66219
Vanderbilt Clinical Trials Center
Nashville, Tennessee, 37212
About this study
Official title: A Multicenter, Double-Blinded, Randomized, Placebo Controlled Study to Investigate the Safety and Immunogenicity of VAX102 When Given in the Same Arm With the Standard Influenza Vaccine in Healthy Adults
The study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.
- Conditions
- Influenza
- Being tested
- VAX102, Placebo
- Keywords
- influenza, universal influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX102Biological
Also called Universal influenza vaccine
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
PlaceboBiological
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
| Study group | Role | What they receive |
|---|---|---|
| VAX102 | Active comparator | Simultaneous administration of VAX102 1 ug i.m. plus TIV Receives: Biological: VAX102 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- VaxInnate Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David N Taylor, MD, Study director, VaxInnate Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921973
- Sponsor's protocol ID
- VAX102-07
- Status last verified
- Sep 2014
- First submitted
- 15 Jun 2009
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Talbot HK, Rock MT, Johnson C, Tussey L, Kavita U, Shanker A, Shaw AR, Taylor DN. Immunopotentiation of trivalent influenza vaccine when given with VAX102, a recombinant influenza M2e vaccine fused to the TLR5 ligand flagellin. PLoS One. 2010 Dec 28;5(12):e14442. doi: 10.1371/journal.pone.0014442.
PubMed 21203437
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blinded, Randomized, Placebo Controlled Study to Investigate the Safety and Immunogenicity of VAX102 When Given in the Same Arm With the Standard Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT00921973
- Acronym / sponsor ID
- VAX102-07
- Conditions
- Influenza
- Keywords
- influenza, universal influenza vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- VaxInnate CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Jun 2009 (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 study will assess the safety, reactogenicity, and tolerability of VAX102 when given with Trivalent Inactivated Influenza Vaccine (TIV) delivered in the same arm as two separate IM injections in healthy adults 18 to 49 years. The investigators will measure the immunogenicity of the VAX102 when given with TIV and the antibody response to TIV when given with VAX102 compared to TIV alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAX102 | Active comparator | Biological: VAX102Simultaneous administration of VAX102 1 ug i.m. plus TIV |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female aged 18 - 49 years inclusive
- Give written informed consent to participate in the study and adherence to all protocol requirements.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
- Females willing to practice birth control during the study.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination.
Key exclusion criteria (18 listed)
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months) as determined by medical history and/or physical exam.
- History of cancer.
- History of impaired immunoresponsiveness, including diabetes.
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs or any components of the study vaccines.
- Received influenza vaccination during the 2008-2009 season
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 |
|---|---|---|
| VAX102Also: Universal influenza vaccineAll subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo | Biological | VAX102 |
| PlaceboAll subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo | Biological | Placebo |
Primary outcome
Immune response
Time frame: 2 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 23 Sep 2014.
- Derived from this study: PubMed 21203437Talbot HK, Rock MT, Johnson C, Tussey L, Kavita U, Shanker A, Shaw AR, Taylor DN. Immunopotentiation of trivalent influenza vaccine when given with VAX102, a recombinant influenza M2e vaccine fused to the TLR5 ligand flagellin. PLoS One. 2010 Dec 28;5(12):e14442. doi: 10.1371/journal.pone.0014442.
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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.
David N Taylor, MD study director
VaxInnate Corporation
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 VAX102 in people with Influenza, run by VaxInnate Corporation 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 7 inclusion and 18 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 23 Sep 2014. 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. 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?
Immune response (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00921973, which also lists 1 linked publication.
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 23 Sep 2014.