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Avian InfluenzaPhase 1NCT01897701

A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

A Phase 1 study testing Monovalent Avian Influenza VLP (H7N9) and Adjuvant 1 in people with Avian Influenza, run by Novavax at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Avian Influenza
What is being tested?
Monovalent Avian Influenza VLP (H7N9) and Adjuvant 1
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
3 sitesAustralia
Study dates
Jul 2013to Aug 2014
Phase
Phase 1
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following to be eligible for participation in the study:
  • Healthy adult male or female, ≥18 years of age,
  • Willing and able to give informed consent prior to study enrollment,
  • Able to comply with study requirements, and
  • Women of childbearing potential must have a negative urine pregnancy test prior to each vaccination, will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or ≥50 years of age and without menses for ≥ 1 year are exempt from urine pregnancy testing.

Who cannot join

  • Subjects meeting any of the following criteria are not eligible for participation in the study.
  • Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
  • Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator.
  • Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see exclusion criteria 2, 5, 7, 8).
  • Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  • History of a serious reaction to prior influenza vaccination.
Show all 17Show fewer
  • History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  • Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
  • Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  • Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  • Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature >38.0°C on the planned day of vaccine administration).
  • Known disturbance of coagulation.
  • Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  • Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  • Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
  • Persons employed in a capacity that involves handling poultry or wild birds.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • CMAX

    Adelaide, South Australia, 5000

  • Q-Pharm Pty Limited

    Herston, Queensland, 4006

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups.

Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

Conditions
Avian Influenza
Being tested
Monovalent Avian Influenza VLP (H7N9), Adjuvant 1, Placebo
Keywords
H7N9
Medical subject headings
Influenza in Birds

What participants receive

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

  • Monovalent Avian Influenza VLP (H7N9)Biological

  • Adjuvant 1Biological

  • PlaceboBiological

Study groups in NCT01897701
Study groupRoleWhat they receive
Group AExperimentalHigh dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9)
Group BExperimentalIntermediate dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 \& 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9)
Group CExperimentalIntermediate dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Adjuvant 1
Group DExperimentalLow dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 \& Day 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Adjuvant 1
Group EExperimentalIntermediate dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Adjuvant 1
Group FExperimentalLow dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 \& 21
Receives: Biological: Monovalent Avian Influenza VLP (H7N9); Biological: Adjuvant 1
Group GExperimentalPlacebo; IM; Day 0 \& 21
Receives: Biological: Placebo

What is being measured

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

  1. Assessment of Safety

    Number (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 35 days post-first injection.

    Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection.

    Measured: Day 0 to Day 384

  2. Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus.

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)

    Measured: Day 0 to Day 384

Secondary outcomes (1)

  1. Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.

    Measured: Day 0 to Day 384

Timeline

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

  1. First posted12 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897701
Sponsor's protocol ID
NVX900.PH7.101
Status last verified
Oct 2014
First submitted
9 Jul 2013
Last updated
13 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Fries LF, Smith GE, Glenn GM. A recombinant viruslike particle influenza A (H7N9) vaccine. N Engl J Med. 2013 Dec 26;369(26):2564-6. doi: 10.1056/NEJMc1313186. Epub 2013 Nov 13. No abstract available.

    PubMed 24224560

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Monovalent Avian Influenza VLP (H7N9) and Adjuvant 1 in people with Avian Influenza, run by Novavax 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 13 Oct 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Assessment of Safety (time frame: Day 0 to Day 384). The study lists 2 primary outcomes in all. 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 NCT01897701, which also lists 1 linked publication.

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 13 Oct 2014.

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