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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921973
• Other study ID #: VAX102-07
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2009
• Last updated: September 22, 2014
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2014
• Source: VaxInnate Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Johnson County Clin Trials	Lenexa	Kansas
United States	Vanderbilt Clinical Trials Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VaxInnate Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response		2 months	No