Safety of VAX102 Vaccine Given With Seasonal Flu Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00921973
First received: June 15, 2009
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: VAX102
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by VaxInnate Corporation:

Primary Outcome Measures:
  • Immune response [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VAX102
Simultaneous administration of VAX102 1 ug i.m. plus TIV
Biological: VAX102
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo
Other Name: Universal influenza vaccine
Placebo Comparator: Placebo Biological: Placebo
All subjects receive TIV, one half of the subjects are randomized to receive VAX102 1 ug and one half are randomized to receive placebo

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921973

Locations
United States, Kansas
Johnson County Clin Trials
Lenexa, Kansas, United States, 66219
United States, Tennessee
Vanderbilt Clinical Trials Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
VaxInnate Corporation
Investigators
Study Director: David N Taylor, MD VaxInnate Corporation
  More Information

No publications provided by VaxInnate Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00921973     History of Changes
Other Study ID Numbers: VAX102-07
Study First Received: June 15, 2009
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxInnate Corporation:
influenza
universal influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014