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InfluenzaPhase 1/2NCT02247362

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

A Phase 1/2 study testing VAX2012Q in people with Influenza, run by VaxInnate Corporation at 3 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
VAX2012Q
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
3 sitesAustralia
Study dates
Nov 2014to Mar 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • CMAX, a division of IDT Australia Limited

    Adelaide, South Australia, 5000

  • Q-Pharm Pty Limited

    Herston, Queensland, 4006

  • Linear Clinical Research Limited

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Conditions
Influenza
Being tested
VAX2012Q, Placebo
Keywords
Safety, Immunogenicity
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VAX2012QBiological

    Also called Quadrivalent Recombinant Hemagglutinin Influenza Vaccine

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

  • PlaceboOther

    Also called Vaccine Diluent

    Vaccine Diluent

Study groups in NCT02247362
Study groupRoleWhat they receive
Vaccine Dose Group 12 mcgExperimentalVAX2012Q, 12 mcg dose
Receives: Biological: VAX2012Q
Vaccine Dose Group 20 mcgExperimentalVAX2012Q, 20 mcg dose
Receives: Biological: VAX2012Q
Vaccine Dose Group 16 mcgExperimentalVAX2012Q; 16 mcg dose
Receives: Biological: VAX2012Q
Vaccine DiluentPlacebo comparatorVaccine Diluent, F147, as placebo control
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 21 days post-immunization; follow up at 6 months and one year

Secondary outcomes (1)

  1. Immune response to vaccine will be measured by serum HAI levels

    Measured: 21 days post-immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionApr 2015
  4. Study completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02247362
Sponsor's protocol ID
VAX2012Q-02
Status last verified
Mar 2015
First submitted
18 Sep 2014
Last updated
17 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VAX2012Q in people with Influenza, run by VaxInnate Corporation at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 21 days post-immunization; follow up at 6 months and one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02247362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.

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