Phase 1 Safety Study of Recombinant Influenza Vaccine for Prevention

March 5, 2015 updated by: VaxInnate Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
316

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Johnson County Clin-Trials
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 4 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 8 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 14 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 18 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 12 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 8 mcg VAX2012Q repeated
8 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine
Experimental: 12 mcg VAX2012Q repeated
12 mcg VAX2012Q
Biological: VAX2012Q
Recombinant influenza HA vaccine delivered IM
Other Names:
  • Quadrivalent Recombinant Hemagglutinin Influenza vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
21 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunogenicity
Time Frame: 21 days and 6 months post-vaccination
Immune response to vaccine will be measured by serum HAI levels
21 days and 6 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VaxInnate Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: C. Jo White, MD, VaxInnate Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VAX2012Q-01
  • BARDA (Other Grant/Funding Number: HHSO10020110011C)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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