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



Status:Not yet recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 64
Updated:7/11/2015
Start Date:May 2015
End Date:June 2016
Contact:Stephen J. Haworth, MD
Email:stephen.haworth@vaxinnate.com
Phone:609-860-2289

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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.
We found this trial at
6
sites
San Diego, California 92108
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Huntsville, Alabama 35802
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Huntsville, AL
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Melbourne, Florida 32934
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Melbourne, FL
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Mishawaka, Indiana 46545
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Mishawaka, IN
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Peoria, Illinois 64614
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Peoria, IL
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Rockville, Maryland 20850
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Rockville, MD
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