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

NCT02247362 | Unknown Phase 1 DMC

• 1 other identifier: VAX2012Q-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Influenza

Keywords

Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immune response to vaccine will be measured by serum HAI levels

  21 days post-immunization

Study Arms (4)

Vaccine Dose Group 12 mcg

EXPERIMENTAL

VAX2012Q, 12 mcg dose

Biological: VAX2012Q

Vaccine Dose Group 20 mcg

EXPERIMENTAL

VAX2012Q, 20 mcg dose

Biological: VAX2012Q

Vaccine Dose Group 16 mcg

EXPERIMENTAL

VAX2012Q; 16 mcg dose

Biological: VAX2012Q

Vaccine Diluent

PLACEBO COMPARATOR

Vaccine Diluent, F147, as placebo control

Other: Placebo

Interventions

VAX2012Q BIOLOGICAL

Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM

Also known as: Quadrivalent Recombinant Hemagglutinin Influenza Vaccine

Vaccine Dose Group 12 mcg; Vaccine Dose Group 16 mcg; Vaccine Dose Group 20 mcg

Placebo OTHER

Vaccine Diluent

Also known as: Vaccine Diluent

Vaccine Diluent

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VaxInnate Corporation: lead

Study Sites (3)

Q-Pharm Pty Limited

Herston, Queensland, 4006, Australia

Location

CMAX, a division of IDT Australia Limited

Adelaide, South Australia, 5000, Australia

Location

Linear Clinical Research Limited

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Lynda Tussey, PHD

  VaxInnate Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 17, 2015

Record last verified: 2015-03

Locations

AU (3)