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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- VaxInnate Corporation
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Seroconversion rates to the 4 components of VAX2012Q
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, 18-64 years of age.
- •Females must be:
- •Surgically sterilized
- •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
- •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
Outcomes
Primary Outcomes
Seroconversion rates to the 4 components of VAX2012Q
Time Frame: Through day 21
Immune response to the vaccine will be measured in sera by the hemagglutination inhibition (HAI) assay.
Secondary Outcomes
- Long term safety following vaccination assessed by Clinically significant AEs(After Day 21 through one year)
- C-reactive protein levels(Through day 7)
- Safety following vaccination assessed by Adverse events (AEs)(Through day 21)
- Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent(Through day 21)