InfluenzaPhase 1NCT02015494
Phase 1 Safety Study of Recombinant Influenza Vaccine for Prevention
A Phase 1 study testing VAX2012Q in people with Influenza, run by VaxInnate Corporation at 4 sites in United States.
Trial summary
One dose of escalating strengths of an investigational influenza vaccine VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for tolerability and immunogenicity in healthy adults 18-40 years of age. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VAX2012Q
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to Dec 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
- Able to provide informed consent indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol
- If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
- Willing to receive the unlicensed vaccine given as an IM injection
- Willing to provide multiple blood specimens collected by venipuncture
Who cannot join
- Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period
- Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
- History of excessive alcohol use, drug abuse or significant psychiatric illness
- Tobacco use within 3 months of enrollment and throughout first 6 months of the study
- Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results
- Clinically significant abnormal liver function tests at screening
Show all 20Show fewer
- Positive serology for HBsAg, HCV or HIV antibodies
- Pregnant or lactating female
- Having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding minor skin cancers, which are allowed unless located at the vaccination site
- Persons with impaired immune responsiveness (of any cause), including diabetes mellitus and autoimmune disorders
- Persons presently receiving or having a recent history of receiving (within the past six months) any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable). Inhaled and topical corticosteroids are allowed.
- Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component
- Persons with a history of Guillain-Barré Syndrome
- Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the three week study period following vaccination
- Donation of blood or blood products within 8 weeks prior to vaccination or during the three week study period following
- An oral temperature >100.4° or acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination; for example, those requiring an absence from work) with or without fever.
- Body Mass Index >29.9
- Any disorder of coagulation
- A clinical diagnosis of influenza within the previous 12 months
- Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tekton Research
Austin, Texas, 78745
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Rochester Clinical Research, Inc
Rochester, New York, 14609
About this study
Official title: Phase 1 Study of the Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 18-40 Years
One dose of escalating strengths of an investigational influenza vaccine VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for tolerability and immunogenicity in healthy adults 18-40 years of age.
Read the detailed description
This is a multi-center, open-label, dose escalating study in which up to 320 healthy subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels. VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four components (VAX128C, VAX181, VAX173 and VAX172) in diluent to produce ten doses in a multi-dose vial for use within 12 hours of preparation. The dose will be prepared from appropriate dilutions from the monovalent drug product vials. Data for safety and immunogenicity will be collected after each dose with safety being assessed after each dose level and immune response, after dose level 4. Reactogenicity and safety labs through Day 1 will be reviewed by the Safety Monitoring Committee (SMC) prior to enrolling in the next dose level.
- Conditions
- Influenza
- Being tested
- VAX2012Q
- Keywords
- Safety, Immunogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX2012QBiological
Also called Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Recombinant influenza HA vaccine delivered IM
| Study group | Role | What they receive |
|---|---|---|
| 4 mcg VAX2012Q | Experimental | 4 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 8 mcg VAX2012Q | Experimental | 8 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 14 mcg VAX2012Q | Experimental | 14 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 18 mcg VAX2012Q | Experimental | 18 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 12 mcg VAX2012Q | Experimental | 12 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 8 mcg VAX2012Q repeated | Experimental | 8 mcg VAX2012Q Receives: Biological: VAX2012Q |
| 12 mcg VAX2012Q repeated | Experimental | 12 mcg VAX2012Q Receives: Biological: VAX2012Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month clinic visit and a 1 year phone call.
Measured: 21 Days
Secondary outcomes (1)
Immunogenicity
Immune response to vaccine will be measured by serum HAI levels
Measured: 21 days and 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- VaxInnate Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C. Jo White, MD, Study director, VaxInnate Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015494
- Sponsor's protocol ID
- VAX2012Q-01
- Other IDs
- BARDA
- Status last verified
- Mar 2015
- First submitted
- 9 Dec 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taylor DN, Treanor JJ, Strout C, Johnson C, Fitzgerald T, Kavita U, Ozer K, Tussey L, Shaw A. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine. 2011 Jul 12;29(31):4897-902. doi: 10.1016/j.vaccine.2011.05.001. Epub 2011 May 17.
PubMed 21596084Treanor JJ, Taylor DN, Tussey L, Hay C, Nolan C, Fitzgerald T, Liu G, Kavita U, Song L, Dark I, Shaw A. Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults. Vaccine. 2010 Dec 6;28(52):8268-74. doi: 10.1016/j.vaccine.2010.10.009. Epub 2010 Oct 20.
PubMed 20969925
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 18-40 Years
- ClinicalTrials.gov ID
- NCT02015494
- Acronym / sponsor ID
- VAX2012Q-01
- Conditions
- Influenza
- Keywords
- Safety, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (actual)
- Lead sponsor
- VaxInnate CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Dec 2013 (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.
One dose of escalating strengths of an investigational influenza vaccine VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) will be evaluated for tolerability and immunogenicity in healthy adults 18-40 years of age.
Detailed description
This is a multi-center, open-label, dose escalating study in which up to 320 healthy subjects age 18-40 years will be administered VAX2012Q at one of up to 7 dose levels. VAX2012Q vaccine will be formulated at the clinical site ("field mix") from the four components (VAX128C, VAX181, VAX173 and VAX172) in diluent to produce ten doses in a multi-dose vial for use within 12 hours of preparation. The dose will be prepared from appropriate dilutions from the monovalent drug product vials. Data for safety and immunogenicity will be collected after each dose with safety being assessed after each dose level and immune response, after dose level 4. Reactogenicity and safety labs through Day 1 will be reviewed by the Safety Monitoring Committee (SMC) prior to enrolling in the next dose level.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 4 mcg VAX2012Q | Experimental | Biological: VAX2012Q4 mcg VAX2012Q |
| 8 mcg VAX2012Q | Experimental | Biological: VAX2012Q8 mcg VAX2012Q |
| 14 mcg VAX2012Q | Experimental | Biological: VAX2012Q14 mcg VAX2012Q |
| 18 mcg VAX2012Q | Experimental | Biological: VAX2012Q18 mcg VAX2012Q |
| 12 mcg VAX2012Q | Experimental | Biological: VAX2012Q12 mcg VAX2012Q |
| 8 mcg VAX2012Q repeated | Experimental | Biological: VAX2012Q8 mcg VAX2012Q |
| 12 mcg VAX2012Q repeated | Experimental | Biological: VAX2012Q12 mcg VAX2012Q |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females aged 18-40 years of age at the time of vaccination in good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator
- Able to provide informed consent indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol
- If the subject is a female of childbearing potential, she must use adequate contraceptive precautions (e.g., intrauterine contraceptive device, oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination and continue to use such precautions for a minimum of three months after vaccination. She must also have a negative urine pregnancy test within 24 hours prior to receiving study vaccine. Women at least one year post-menopausal or surgically sterile will not be considered of childbearing potential.
- Willing to receive the unlicensed vaccine given as an IM injection
- Willing to provide multiple blood specimens collected by venipuncture
Key exclusion criteria (20 listed)
- Use of any investigational or non-registered drug or vaccine product within 30 days preceding the administration of the study vaccine or planned use within the first six weeks of the study period
- Has received any licensed or other investigational influenza vaccine within 3 months prior to enrollment in this study or expected receipt of any influenza vaccination before the Day 21 blood collection
- History of excessive alcohol use, drug abuse or significant psychiatric illness
- Tobacco use within 3 months of enrollment and throughout first 6 months of the study
- Has a chronic illness (e.g., liver or kidney disease), receiving a concomitant therapy or have any other condition that could interfere with the subject's participation in the study or in the interpretation of the study results
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 |
|---|---|---|
| VAX2012QAlso: Quadrivalent Recombinant Hemagglutinin Influenza vaccineRecombinant influenza HA vaccine delivered IM | Biological | 12 mcg VAX2012Q, 12 mcg VAX2012Q repeated, 14 mcg VAX2012Q, 18 mcg VAX2012Q, 4 mcg VAX2012Q, 8 mcg VAX2012Q, 8 mcg VAX2012Q repeated |
Primary outcome
Safety
Time frame: 21 Days
Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month clinic visit and a 1 year phone call.
1 secondary outcome
Immunogenicity
Time frame: 21 days and 6 months post-vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 21596084Taylor DN, Treanor JJ, Strout C, Johnson C, Fitzgerald T, Kavita U, Ozer K, Tussey L, Shaw A. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine. 2011 Jul 12;29(31):4897-902. doi: 10.1016/j.vaccine.2011.05.001. Epub 2011 May 17.
- Background: PubMed 20969925Treanor JJ, Taylor DN, Tussey L, Hay C, Nolan C, Fitzgerald T, Liu G, Kavita U, Song L, Dark I, Shaw A. Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults. Vaccine. 2010 Dec 6;28(52):8268-74. doi: 10.1016/j.vaccine.2010.10.009. Epub 2010 Oct 20.
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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.
C. Jo White, MD study director
VaxInnate Corporation
4 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 VAX2012Q in people with Influenza, run by VaxInnate Corporation at 4 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 5 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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 (time frame: 21 Days). 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 NCT02015494, which also lists 2 linked publications.
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 6 Mar 2015.