A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant
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™
1 other identifier
interventional
610
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 23, 2016
September 1, 2016
1.3 years
March 3, 2014
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of Safety
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.
Day 0 to Day 384
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)
Day 0 to Day 384
Secondary Outcomes (1)
Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9.
Day 0 to Day 384
Study Arms (8)
Group A
EXPERIMENTALPlacebo
Group B
EXPERIMENTALHigh dose Monovalent Avian Influenza VLP (H7N9); IM; Day 0 and Day 21
Group C
EXPERIMENTALHigh dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Group D
EXPERIMENTALIntermediate dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Group E
EXPERIMENTALLow dose Monovalent Avian Influenza VLP (H7N9) with Low dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Group F
EXPERIMENTALHigh dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Group G
EXPERIMENTALIntermediate dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Group H
EXPERIMENTALLow dose Monovalent Avian Influenza VLP (H7N9) with High dose Matrix-M1™ adjuvant; IM; Day 0 and Day 21
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult male or female, 18 to 64 years of age,
- Willing and able to give informed consent prior to study enrollment,
- Able to comply with study requirements, and
- 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.
You may not qualify if:
- Subjects will be excluded if they meet any of the following criteria:
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
- 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.
- 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.
- 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.
- 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 ≥10mg 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
- Department of Health and Human Servicescollaborator
Study Sites (5)
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Miami Research Associates
Miami, Florida, 33143, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Coastal Carolina Research
Mt. Pleasant, South Carolina, 29464, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
D. Nigel Thomas, Ph. D.
Novavax, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 5, 2014
Study Start
March 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 23, 2016
Record last verified: 2016-09