Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years

A Phase II, Multicenter, Randomized, Double-Blind, Active Comparator Controlled Study of the Immunogenicity and Safety of VAX2012Q, A Quadrivalent Influenza Vaccine in Healthy Adults 18-64 Years

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Biological: VAX2012Q; Biological: Fluzone Quadrivalent

Detailed Description

This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either VAX2012Q or Fluzone. Four hundred fifty (450) subjects will be randomized 1:1:1 ratio of either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine.

Randomization will be stratified for age (18-49 and 50-64 years). Subjects will be stratified by two age groups (18-49 and 50-64) and randomized in a 1:1:1 ratio to either 8 or 12 mcg VAX2012Q dose levels or to Fluzone® Quadrivalent vaccine. 25-35% of the total study population will be recruited into the 50-64 age group.

The primary objective of the study is to evaluate the seroconversion rates at Day 21 for both dose levels of VAX2012Q.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Optimal Research
  • California
    • San Diego, California, United States, 92108
      • Optimal Research
  • Florida
    • Melbourne, Florida, United States, 32934
      • Optimal Research
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research
  • Indiana
    • Mishawaka, Indiana, United States, 46545
      • Optimal Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Optimal Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females, 18-64 years of age.

• Females must be:

  1. Surgically sterilized
  2. Post menopausal:
• 12 months of spontaneous amenorrhea or
• 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 milli-International Units (mIU)/ml or

• 6 weeks postsurgical bilateral oophorectomy

  3. Those of childbearing potential must have a negative pre-treatment serum pregnancy test followed by a confirmatory urine pregnancy test immediately prior to vaccination and must agree to use a reliable form of contraception for at least 21 days post vaccination including contraceptives, intrauterine device, double-barrier method.

• In good health as determined by medical history, physical exam, laboratory assessments and the clinical judgment of the Principal Investigator.
• Must sign informed consent indicating understanding of the purpose of and procedures required for the study and willingness to participate.

Exclusion Criteria:

• Within 6 months preceding the administration of the study vaccine, receiving any licensed or investigational vaccine.
• Within 30 days preceding the administration of the study vaccine, receiving any investigational drug.
• Excessive chronic alcohol use within the last 5 years.
• History of drug abuse, other than recreational cannabis use, within the last 5 years that could affect the subject's participation in the study.
• Significant psychiatric illness within the last 12 months which would interfere with the study.
• A chronic illness that is not medically stable, receiving a concomitant therapy in which the medication dose has not been stable for at least 3 months prior to immunization or has any other condition that could interfere with the study.
• Clinically significant abnormal liver function tests at screening: alanine transaminase (ALT) or aspartate aminotransferase (AST) >2.5 Upper Limit of Normal (ULN).
• Total bilirubin > 1.5 ULN if ALT or AST > ULN or total bilirubin > 2 ULN with ALT and AST within normal range .
• Creatinine >1.7mg/dL, Hemoglobin < 11g/dL for females; <12.5 g/dL for males, white blood cells (WBC) <2500cell/mm3 or > 15,000cell/mm3, Platelet Count <125,000cell/mm3
• Positive serology for HBSAg, hepatitis C virus (HCV) or HIV
• Have cancer or have received treatment for cancer within three years, excluding in situ cervical carcinoma or basal /squamous cell carcinoma of the skin at other than the vaccination site.
• Any autoimmune disease.
• Presently receiving or having a recent history of receiving (≤ six months) any medication or therapeutic modality that affects the immune system or a drug known to be frequently associated with significant major organ toxicity or system corticosteroids (oral or injectable).
• History of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component.
• Allergic to egg or egg products.
• 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 4 weeks prior to vaccination or during the 4 week study period following vaccination.
• Acute disease within 72 hours prior to vaccination.
• An oral temperature >100.4°F (38°C) on the day of vaccination
• Body Mass Index >40.
• Known bleeding disorders or receiving prescribed oral or parenteral anticoagulants.
• Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study or could interfere with study evaluations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Dose Group 8 mcg dose; VAX2012Q, 8 mcg dose	Biological: VAX2012Q; Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages; Other Names: RIV4; Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
Experimental: Vaccine Dose Group 12 mcg dose; VAX2012Q, 12 mcg dose	Biological: VAX2012Q; Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages; Other Names: RIV4; Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
Active Comparator: Control; Fluzone Quadrivalent vaccine	Biological: Fluzone Quadrivalent; Fluzone Quadrivalent (Influenza Vaccine); Other Names: IIV4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rates to the 4 components of VAX2012Q	Immune response to the vaccine will be measured in sera by the hemagglutination inhibition (HAI) assay.	Through day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety following vaccination assessed by Adverse events (AEs)	vital signs, laboratory test results and analgesic and antipyretic use to treat symptoms emerging post vaccination will be collected.	Through day 21
Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent	Immune responses to the vaccines will be measured in sera by HAI assay.	Through day 21
C-reactive protein levels	Measure C-reactive protein levels.	Through day 7
Long term safety following vaccination assessed by Clinically significant AEs	including Serious Adverse Events, Adverse Events of Special Interest and new onset chronic diseases, will be collected.	After Day 21 through one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of immunity	Immune responses will be measured in sera by HAI assay.	Through day 90
Breadth of immunity	Immune responses to influenza virus strains not contained in the vaccines will be measured in sera by HAI assay.	Through day 90

Collaborators and Investigators

• Sponsor: VaxInnate Corporation
• Collaborators: Department of Health and Human Services; Accelovance
• Investigators: Study Director: Stephen J. Haworth, MD, VaxInnate Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): June 26, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Agglutinins; Hemagglutinins
• Other Study ID Numbers: VAX2012Q-03