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.

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.

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.