Clinical trial NCT02434276: Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Influenza
Lead sponsor: VaxInnate Corporation
Sponsor class: INDUSTRY
Collaborators: name: Accelovance
name: Department of Health and Human Services
First posted: 2015-05-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Seroconversion rates to the 4 components of VAX2012Q
timeFrame: Through day 21
Secondary outcomes:
measure: Safety following vaccination assessed by Adverse events (AEs)
timeFrame: Through day 21
measure: Immunogenicity of the two dose levels of VAX2012Q and of Fluzone Quadrivalent
timeFrame: Through day 21
measure: C-reactive protein levels
timeFrame: Through day 7
measure: Long term safety following vaccination assessed by Clinically significant AEs
timeFrame: After Day 21 through one year
Other outcomes:
measure: Duration of immunity
timeFrame: Through day 90
measure: Breadth of immunity
timeFrame: Through day 90
Locations:
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Mishawaka
country: United States
facility: Optimal Research
state: Indiana
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
Study officials:
affiliation: VaxInnate Corporation
name: Stephen J. Haworth, MD
role: STUDY_DIRECTOR
References: