Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years

Phase 1b/2 Double Blind, Randomized, Placebo Controlled Study of Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years

One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled study.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Biological: VAX2012Q; Other: Placebo

Detailed Description

The purpose of this study is to evaluate, in a stepwise fashion, dose levels for an investigational quadrivalent influenza vaccine containing 2 influenza A strains and 2 influenza B strains. This is a multi-center, randomized, double-blind, placebo-controlled, dose escalating study in which up to 200 healthy adults age 65-75 years will be administered a single dose of either placebo or an investigational influenza vaccine (VAX2012Q, Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) at one of up to 3 dose levels. Fifty or up to 75 subjects will be enrolled in each dose level. Data for safety and immunogenicity will be collected for all dose levels.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Q-Pharm Pty Limited
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX, a division of IDT Australia Limited
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females aged 65-75 years of age at the time of vaccination in good health. Individuals that are stably treated for hypertension may be eligible.
• Able to provide informed consent
• Willing to receive the unlicensed vaccine
• Willing to provide multiple blood specimens
• Live in the community, independently or in an assisted living environment
• Based on the results of the Short Portable Mental Status Questionnaire be rated as normal or have no greater than mild severity dementia
• As defined by the Canadian Study of Health and Aging Clinical Frailty Scale be a Class 1 to 5

Exclusion Criteria:

• Preceding the administration of study vaccine, has received or will receive 1) any licensed or investigational influenza vaccine product within 6 months, 2) any investigational drug or any investigational vaccine product other than influenza vaccine within the 30 days, 3) any licensed live vaccine other than influenza vaccine within 4 weeks, 4) any licensed inactivated vaccine other than influenza vaccine within 2 weeks
• Planned receipt before the Day 21 blood draw of 1) any licensed or investigational influenza vaccine product, 2) any investigational drug or any investigational vaccine product other than influenza vaccine, 3) any licensed live vaccine other than influenza vaccine, 4) any licensed inactivated vaccine other than influenza vaccine
• History of excessive alcohol use, drug abuse or significant psychiatric illness
• Has a chronic illness that is not medically stable, is receiving a concomitant therapy in which the medication dose has not been stable for at least 3 weeks prior to immunization or has any other condition that could interfere with the subject's participation in the study or interpretation of the study results
• Clinically significant abnormal liver function tests at screening
• Subjects with Grade 2 or higher abnormalities in total bilirubin at screening
• Subjects with any of the following laboratory abnormalities at screening: Creatinine >1.7mg/dL, Hemoglobin < 11g/dL for females; <12.5 g/dL for males, WBC <2500cell/mm3 or > 15,000cell/mm3 and Platelet Count <125,000cell/mm3
• Positive serology of HBSAg, HCV or HIV antibodies
• Having cancer or have received treatment for cancer within three years, excluding minor skin cancers, which are allowed unless located at the vaccination site. Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
• Persons with impaired immune responsiveness (of any cause), including Type 1 diabetes mellitus and auto immune disorders or any known or suspected autoimmune disease
• Persons with congenital immunodeficiency or history of acquired immunodeficiency, or immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months.
• Persons with a history of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component
• Persons with a history of Guillain-Barré Syndrome
• Receipt or donation of blood or blood products 8 weeks prior to vaccination or during the three week study period following vaccination
• Acute disease within 72 hours prior to vaccination.
• An oral temperature >100.4°F (38°C)
• Systolic blood pressure < 85 mm Hg and subjects whose hypertension is untreated or unstable with antihypertensive therapy or that have systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg requiring medical intervention with more than one drug or more intensive therapy than previously used or indicated.
• Body Mass Index >40
• Disorders of coagulation
• Women less than 1 year post menopausal
• A clinical diagnosis of influenza within the previous 6 months
• Any other condition or circumstance which, in the opinion of the Principal Investigator, poses an unacceptable risk for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine Dose Group 12 mcg; VAX2012Q, 12 mcg dose	Biological: VAX2012Q; Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM; Other Names: Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
Experimental: Vaccine Dose Group 20 mcg; VAX2012Q, 20 mcg dose	Biological: VAX2012Q; Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM; Other Names: Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
Experimental: Vaccine Dose Group 16 mcg; VAX2012Q; 16 mcg dose	Biological: VAX2012Q; Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM; Other Names: Quadrivalent Recombinant Hemagglutinin Influenza Vaccine
Placebo Comparator: Vaccine Diluent; Vaccine Diluent, F147, as placebo control	Other: Placebo; Vaccine Diluent; Other Names: Vaccine Diluent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Injection site and systemic symptoms will be collected for 21 days after vaccination. Other AEs assessed as related to vaccination will be collected at a 6 month and 1 year phone call.	21 days post-immunization; follow up at 6 months and one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Immune response to vaccine will be measured by serum HAI levels	21 days post-immunization

Collaborators and Investigators

• Sponsor: VaxInnate Corporation
• Investigators: Study Director: Lynda Tussey, PHD, VaxInnate Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 23, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Agglutinins; Vaccines; Hemagglutinins
• Other Study ID Numbers: VAX2012Q-02