NCT02015494

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
316

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

December 9, 2013

Last Update Submit

March 5, 2015

Conditions

Influenza

Keywords

SafetyImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • 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.

    21 Days

Secondary Outcomes (1)

  • Immunogenicity

    21 days and 6 months post-vaccination

Study Arms (7)

4 mcg VAX2012Q

EXPERIMENTAL

4 mcg VAX2012Q

Biological: VAX2012Q

8 mcg VAX2012Q

EXPERIMENTAL

8 mcg VAX2012Q

Biological: VAX2012Q

14 mcg VAX2012Q

EXPERIMENTAL

14 mcg VAX2012Q

Biological: VAX2012Q

18 mcg VAX2012Q

EXPERIMENTAL

18 mcg VAX2012Q

Biological: VAX2012Q

12 mcg VAX2012Q

EXPERIMENTAL

12 mcg VAX2012Q

Biological: VAX2012Q

8 mcg VAX2012Q repeated

EXPERIMENTAL

8 mcg VAX2012Q

Biological: VAX2012Q

12 mcg VAX2012Q repeated

EXPERIMENTAL

12 mcg VAX2012Q

Biological: VAX2012Q

Interventions

VAX2012QBIOLOGICAL

Recombinant influenza HA vaccine delivered IM

Also known as: Quadrivalent Recombinant Hemagglutinin Influenza vaccine
12 mcg VAX2012Q12 mcg VAX2012Q repeated14 mcg VAX2012Q18 mcg VAX2012Q4 mcg VAX2012Q8 mcg VAX2012Q8 mcg VAX2012Q repeated

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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-BarrĂ© 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Related Publications (2)

  • 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.

    PMID: 21596084BACKGROUND

  • Treanor 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.

    PMID: 20969925BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • C. Jo White, MD

    VaxInnate Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 19, 2013

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(4)