InfluenzaPhase 1VAX128-01NCT01172054
Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults
A Phase 1 study testing VAX128 in people with Influenza, run by VaxInnate Corporation at 2 sites in United States.
Trial summary
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VAX128
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Nov 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female aged 18 - 49 years or >= 65 years
- Give written informed consent
- Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
- Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
- Willing to provide multiple blood specimens collected by venipuncture
Who cannot join
- Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
- Impaired immune responsiveness
- Received drugs effecting the immunity
- Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
- History of anaphylactic type reaction to injected vaccines.
- History of drug abuse in the year prior to screening.
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- History of Guillain-Barré Syndrome.
- Receipt or donation of blood products
- Acute disease within 72 hours prior to vaccination
- History of heart or lung disease
- Has other conditions that might interfere with study objectives.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johnson County Clin-Trials
Lenexa, Kansas, 66219
Miami Research Associates
Miami, Florida, 33143
About this study
Official title: A Phase I Escalating Dose Ranging Study to Evaluate the Safety and Immunogenicity of the VAX128 A, B, and C Novel H1N1 Influenza Vaccine Constructs in Healthy Adults 18-49 Years of Age and in Community Living Adults ≥65 Years of Age
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
Read the detailed description
VAX128-01 is a first in human study of three inactivated recombinant novel H1N1 influenza vaccines, designated VAX128 A, B and C. The purpose of the study is to compare the safety and immunogenicity of the three vaccines through a range of doses and to select one of the vaccines for further testing in phase II studies. We plan to assess the safety and immunogenicity in a dose escalating study. The study will enroll up to 100 healthy young adults (18-49 years) and 100 healthy adults than age 65 years. We are including the older adults in this phase 1 study because we have found that the elderly tolerated a vaccine similar to one of the candidates, VAX128A, better than young adults, but required a higher vaccine dose to achieve a similar antibody response. Nevertheless, because we are testing two other constructs (VAX128B and C), we will be making the conservative assumptions that the safety and immunogenicity data coming from the young adults will not predict the results in the elderly. Therefore, we will begin the study in the young adults and after the first three dose levels have been tested we will begin testing in the older adults. In this study we plan to enroll up to 100 young adults and up to 100 adults 65 years and older. The young adults will be most likely enrolled at one clinical site and the older adults will be enrolled at another clinical site. We plan to enroll a cohort of 10 young adults and 10 older adults every week. Each cohort will consist of 3 subjects to receive one of the three vaccines (9 subjects total) and one subject in each cohort will receive placebo. Dosing for the next cohort will be based on a two day assessment period after vaccination. The main part of the study will be conducted over 28 days and there will be two follow up phone calls at 6 months and one year.
- Conditions
- Influenza
- Being tested
- VAX128, Placebo
- Keywords
- influenza vaccine recombinant
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAX128Biological
Also called STF2.HA1 CA07
one IM injection
PlaceboBiological
One IM injection
| Study group | Role | What they receive |
|---|---|---|
| VAX128 | Experimental | Novel H1N1 Influenza vaccine Receives: Biological: VAX128 |
| Placebo | Placebo comparator | one IM injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising etc) or systemic (headache, muscle aches, fatigue, etc) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine construct or placebo.
Measured: 28 days
Secondary outcomes (1)
Immunogenicity
To assess serm immune response, sera collected at Day 0 (pre-vaccination), 7, 14 and 28 will be analyzed for HAI, serum IgG anti-HA by ELISA and serum IgG anti-flagellin by ELISA. The geometric mean, seroconversion and seroprotection rates will be determined.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionNov 2011
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, Care provider, Investigator
- Enrolment
- 292 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
- NCT01172054
- Sponsor's protocol ID
- VAX128-01
- Acronym
- VAX128-01
- Status last verified
- Jul 2012
- First submitted
- 26 Jul 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taylor DN, Treanor JJ, Sheldon EA, Johnson C, Umlauf S, Song L, Kavita U, Liu G, Tussey L, Ozer K, Hofstaetter T, Shaw A. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine. 2012 Aug 24;30(39):5761-9. doi: 10.1016/j.vaccine.2012.06.086. Epub 2012 Jul 11.
PubMed 22796139
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Escalating Dose Ranging Study to Evaluate the Safety and Immunogenicity of the VAX128 A, B, and C Novel H1N1 Influenza Vaccine Constructs in Healthy Adults 18-49 Years of Age and in Community Living Adults ≥65 Years of Age
- ClinicalTrials.gov ID
- NCT01172054
- Acronym / sponsor ID
- VAX128-01 / VAX128-01
- Conditions
- Influenza
- Keywords
- influenza vaccine recombinant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- VaxInnate CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Jul 2010 (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.
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
Detailed description
VAX128-01 is a first in human study of three inactivated recombinant novel H1N1 influenza vaccines, designated VAX128 A, B and C. The purpose of the study is to compare the safety and immunogenicity of the three vaccines through a range of doses and to select one of the vaccines for further testing in phase II studies. We plan to assess the safety and immunogenicity in a dose escalating study. The study will enroll up to 100 healthy young adults (18-49 years) and 100 healthy adults than age 65 years. We are including the older adults in this phase 1 study because we have found that the elderly tolerated a vaccine similar to one of the candidates, VAX128A, better than young adults, but required a higher vaccine dose to achieve a similar antibody response. Nevertheless, because we are testing two other constructs (VAX128B and C), we will be making the conservative assumptions that the safety and immunogenicity data coming from the young adults will not predict the results in the elderly. Therefore, we will begin the study in the young adults and after the first three dose levels have been tested we will begin testing in the older adults. In this study we plan to enroll up to 100 young adults and up to 100 adults 65 years and older. The young adults will be most likely enrolled at one clinical site and the older adults will be enrolled at another clinical site. We plan to enroll a cohort of 10 young adults and 10 older adults every week. Each cohort will consist of 3 subjects to receive one of the three vaccines (9 subjects total) and one subject in each cohort will receive placebo. Dosing for the next cohort will be based on a two day assessment period after vaccination. The main part of the study will be conducted over 28 days and there will be two follow up phone calls at 6 months and one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAX128 | Experimental | Biological: VAX128Novel H1N1 Influenza vaccine |
| Placebo | Placebo comparator | Biological: Placeboone IM injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female aged 18 - 49 years or >= 65 years
- Give written informed consent
- Females have a negative urine test for pregnancy before vaccination and use birth control during 28 day study period
- Willing to receive the unlicensed (VAX128) vaccine given as an i.m. injection
- Willing to provide multiple blood specimens collected by venipuncture
Key exclusion criteria (11 listed)
- Chronic illness that would interfere with the subject's participation in the study or interpretation of the study results.
- Impaired immune responsiveness
- Received drugs effecting the immunity
- Received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during the study, including licensed influenza vaccines.
- History of anaphylactic type reaction to injected vaccines.
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 |
|---|---|---|
| VAX128Also: STF2.HA1 CA07one IM injection | Biological | VAX128 |
| PlaceboOne IM injection | Biological | Placebo |
Primary outcome
Safety
Time frame: 28 days
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising etc) or systemic (headache, muscle aches, fatigue, etc) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine construct or placebo.
1 secondary outcome
Immunogenicity
Time frame: 28 days
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 31 Jul 2012.
- Derived from this study: PubMed 22796139Taylor DN, Treanor JJ, Sheldon EA, Johnson C, Umlauf S, Song L, Kavita U, Liu G, Tussey L, Ozer K, Hofstaetter T, Shaw A. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine. 2012 Aug 24;30(39):5761-9. doi: 10.1016/j.vaccine.2012.06.086. Epub 2012 Jul 11.
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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 VAX128 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 5 inclusion and 11 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 31 Jul 2012. 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?
Safety (time frame: 28 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 NCT01172054, 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 31 Jul 2012.