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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897701
First Posted: July 12, 2013
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novavax
  Purpose

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.


Condition Intervention Phase
Avian Influenza Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Adjuvant 1 Biological: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novavax:

Primary Outcome Measures:
  • Assessment of Safety [ Time Frame: Day 0 to Day 384 ]

    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.


  • Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus. [ Time Frame: Day 0 to Day 384 ]
    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)


Secondary Outcome Measures:
  • Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9. [ Time Frame: Day 0 to Day 384 ]

Enrollment: 280
Study Start Date: July 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 & 21
Biological: Monovalent Avian Influenza VLP (H7N9)
Experimental: Group B
Intermediate dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 & 21
Biological: Monovalent Avian Influenza VLP (H7N9)
Experimental: Group C
Intermediate dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 & 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Adjuvant 1
Experimental: Group D
Low dose Monovalent Avian Influenza VLP (H7N9) and Low dose Adjuvant 1; IM; Day 0 & Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Adjuvant 1
Experimental: Group E
Intermediate dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 & 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Adjuvant 1
Experimental: Group F
Low dose Monovalent Avian Influenza VLP (H7N9) and High dose Adjuvant 1; IM; Day 0 & 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Adjuvant 1
Experimental: Group G
Placebo; IM; Day 0 & 21
Biological: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet all of the following to be eligible for participation in the study:

  1. Healthy adult male or female, ≥18 years of age,
  2. Willing and able to give informed consent prior to study enrollment,
  3. Able to comply with study requirements, and
  4. 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.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for participation in the study.

  1. 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).
  2. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  3. History of a serious reaction to prior influenza vaccination.
  4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  5. Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
  6. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  7. 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.
  8. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  9. 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).
  10. Known disturbance of coagulation.
  11. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  12. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  13. 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).
  14. Persons employed in a capacity that involves handling poultry or wild birds.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897701


Locations
Australia, Queensland
Q-Pharm Pty Limited
Herston, Queensland, Australia, 4006
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT01897701     History of Changes
Other Study ID Numbers: NVX900.PH7.101
First Submitted: July 9, 2013
First Posted: July 12, 2013
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by Novavax:
H7N9

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases