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
1 other identifier
interventional
450
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 26, 2015
June 1, 2015
3 months
April 16, 2015
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
C-reactive protein levels
Through day 7
Long term safety following vaccination assessed by Clinically significant AEs
After Day 21 through one year
Other Outcomes (2)
Duration of immunity
Through day 90
Breadth of immunity
Through day 90
Study Arms (3)
Vaccine Dose Group 8 mcg dose
EXPERIMENTALVAX2012Q, 8 mcg dose
Vaccine Dose Group 12 mcg dose
EXPERIMENTALVAX2012Q, 12 mcg dose
Control
ACTIVE COMPARATORFluzone Quadrivalent vaccine
Interventions
Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages
Eligibility Criteria
You may qualify if:
- Males and females, 18-64 years of age.
- Females must be:
- Surgically sterilized
- Post menopausal:
- months of spontaneous amenorrhea or
- months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 milli-International Units (mIU)/ml or
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VaxInnate Corporationlead
- Accelovancecollaborator
- Department of Health and Human Servicescollaborator
Study Sites (6)
Optimal Research
Huntsville, Alabama, 35802, United States
Optimal Research
San Diego, California, 92108, United States
Optimal Research
Melbourne, Florida, 32934, United States
Optimal Research
Peoria, Illinois, 61614, United States
Optimal Research
Mishawaka, Indiana, 46545, United States
Optimal Research
Rockville, Maryland, 20850, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephen J. Haworth, MD
VaxInnate Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2015
First Posted
May 5, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2015
Study Completion
June 1, 2016
Last Updated
June 26, 2015
Record last verified: 2015-06