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A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

This study has been completed.
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT02078674
First received: March 3, 2014
Last updated: September 20, 2016
Last verified: September 2016
  Purpose

This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise ~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years.

Each subject will receive two identical IM doses of test article 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
Influenza (Pandemic)
Biological: Monovalent Avian Influenza VLP (H7N9)
Biological: Matrix-M1™ adjuvant
Biological: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I/II Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/13 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Matrix-M1™

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 ]

    Counts (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 42 days post-first injection.

    In addition, MAEs, SAEs, and SNMCs will be collected for one year.


  • 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: 610
Study Start Date: March 2014
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Placebo
Biological: Placebo
Experimental: Group B
High dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9)
Experimental: Group C
High dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant
Experimental: Group D
Intermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant
Experimental: Group E
Low dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant
Experimental: Group F
High dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant
Experimental: Group G
Intermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant
Experimental: Group H
Low dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Biological: Monovalent Avian Influenza VLP (H7N9) Biological: Matrix-M1™ adjuvant

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male or female, 18 to 64 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 child-bearing potential must have a negative urine pregnancy test prior to each vaccination, and 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 will be excluded if they meet any of the following criteria:

  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.
    • Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
    • Note that illnesses or conditions may be exclusionary, even if otherwise stable and clinically minor, due to therapies used to treat them (see exclusion criteria 3, 5, 8, 9).
  2. Any grade 1 or higher (as based on the Toxicity Grading Scale [TGS]) abnormality in ALT, AST, alkaline phosphatase, total bilirubin, blood urea nitrogen, or creatinine levels.
  3. Any grade 2 or higher (as based on the TGS) vital sign or clinical laboratory abnormality not specified in criterion 2 above. Note that any abnormal vital sign may be repeated at the Investigator's discretion.
  4. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
  5. History of a serious reaction to prior influenza vaccination.
  6. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.
  7. Received any vaccine in the 4 weeks preceding the study vaccination; or any A(H7N9) avian influenza vaccine at any time.
  8. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
  9. 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 ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
  10. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
  11. 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).
  12. Known disturbance of coagulation.
  13. Women who are pregnant or breastfeeding, or plan to become pregnant during the study.
  14. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078674

Locations
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, New York
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
United States, South Carolina
Coastal Carolina Research
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Novavax
Department of Health and Human Services
Investigators
Study Director: D. Nigel Thomas, Ph. D. Novavax, Inc.
  More Information

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT02078674     History of Changes
Other Study ID Numbers: FLU-MI7A-201
Study First Received: March 3, 2014
Last Updated: September 20, 2016

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

ClinicalTrials.gov processed this record on April 21, 2017