- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991561
Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.
June 8, 2020 updated by: Medicago
Immunogenicity, Safety, Tolerability of a Plant-made H5 VLP Influenza Vaccine.
A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in healthy adults 18-60 years of age.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will consist of a dose-ranging in 390 subjects who will be randomized to receive one injection at Days 0 and 21 of either a low, medium or a high dose of H5 VLP Influenza vaccine combined with Alhydrogel®, or a low or high dose of H5 VLP Influenza vaccine combined with GLA-SE, or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM Sodium Chloride (NaCl) + 0.01% Tween 80).
Seven-day (7) safety data after the first immunization of the first 25% study subjects enrolled (98 subjects) will be tabulated and reviewed by the Data and Safety Monitoring Board (DSMB), prior to permitting the first immunization of the remaining study subjects and the second immunisations.
Also, based on medical expert opinion and on safety criteria defined in the protocol, a DSMB review might be necessary on the seven-day safety data of the same 25% study subjects following administration of their second dose, before proceeding to the second immunizations of the remaining study subjects.
Twenty-one (21) days after each immunization, key safety and immunogenicity data will be collected and analysed.
All subjects will be followed for safety until Day 407.
Study Type
Interventional
Enrollment (Actual)
390
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5V2T3
- INC Research
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Quebec
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Pierrefonds, Quebec, Canada, H9H4Y6
- MUHC Vaccine Study Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female adults, 18 to 60 years of age, inclusive
- Healthy as judged by the Investigator and determined by medical history, history/symptom-directed physical examination, vital signs, screening laboratories and medical history conducted no more than 30 days prior to study vaccine administration;
- BMI of ≥18 and ≤ 32;
- Comprehension of the study requirements, expressed availability for the required study period and ability to attend scheduled visits;
- Accessible by telephone on a regular basis;
- In the opinion of the Investigator, ability and willingness to provide written, informed consent for participation after reading the informed consent form. The subject must have adequate opportunity to discuss the study with an Investigator or qualified designee;
- If female, have a negative serum pregnancy test result at study entry, and if capable of child bearing has been consistently using effective birth control for the 28 days prior to study entry and agree to continue employing adequate birth control measures for the duration of the study.
Exclusion Criteria:
Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
- Requiring a new medical or surgical treatment within one month prior to study vaccine administration;
- Requiring a change in medication dosage in one month prior to test article administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
- Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to test article administration;
- Any medical or neuropsychiatric condition which, in the Investigator's opinion, would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting;
- Any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection or Hepatitis B or C or presence of lymphoproliferative disease;
- Presence of any febrile illness, oral temperature of >38.0˚C within 24 hours of test article administration. Such subjects may be re-evaluated for enrolment after resolution of illness;
- History of autoimmune disease;
- Administration of any vaccine (including any other influenza vaccine) within a 30 day period prior to study enrolment, or planned administration within the period from the first vaccination up to blood sampling at Day 42 or within 30 days prior to blood sampling at Day 228. Immunization on an emergency basis of a tetanus and diphtheria toxoids adsorbed for adult use (Td) will be allowed provided the vaccine is not administered within two weeks prior to test article administration. Receipt of any other emergency immunizations (e.g. rabies) will result in a case-by-case review of continued participation;
- Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period. Subjects may not participate in any other drug study while participating in this study;
- Treatment with systemic glucocorticoids at a dose exceeding ≥ 10 mg of prednisone per day, or equivalent for more than 7 consecutive days or for 10 or more days in total, within one month of first test article administration, or any other cytotoxic or immunosuppressant drug or any immune globulin preparation within three months of vaccination. Nasal or inhaled glucocorticoids are allowed;
- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically apparent bleeding tendency are eligible;
- History of previous H5N1 vaccination or a history of exposure to H5N1 virus. Any subject that was enrolled on our previous H5 studies (except the ones that received placebo) would not be eligible;
- Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
- History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminum hydroxide), GLA-SE, or the phosphate buffer;
- History of severe allergic reactions (including anaphylaxis) to any food, medication, or bee sting or previous status of asthmatic;
- History of tobacco allergy;
- History of egg allergy (). GLA-SE contains egg phosphatidylcholine.
- Continuous use of anti-histamines in last 4 weeks prior to immunization and use of antihistamine in last 48 hours prior to immunization;
- Have a rash, dermatological condition or tattoos or a muscle mass condition at the injection site that may interfere with injection site reaction rating. ;
- Have received a blood transfusion or immunoglobulins within 90 days of study entry;
- If female, and of childbearing potential, has not been consistently using effective birth control for the 28 days prior to study entry. An example of highly effective birth control is oral contraceptives, hormone implants, abstinence (self-reported), or male condom plus spermicide. All female subjects, regardless of birth control history must provide a serum sample for pregnancy screening. Effective birth control must be used for the duration of the study for female of child bearing potential. The subject must have no plan to become pregnant during the study period;
- Among female subjects, either known pregnancy or urine beta-human chorionic gonadotropin (ß-hCG) test results consistent with pregnancy prior to test article administration on Day 0 and 21;
- Female subjects who are lactating;
- Vital sign abnormalities: systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg, resting pulse rate <40 bpm or >100 bpm or according to the Investigator's opinion;
- Cancer or treatment for cancer within 3 years of test article administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose of H5 VLP vaccine + Alhydrogel
Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel
|
Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel
|
Experimental: Med dose H5 VLP vaccine + Alhydrogel
Biological:Med dose of H5 VLP vaccine + Alhydrogel, 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel
|
Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel
|
Experimental: High dose of H5 VLP vaccine + Alhydrogel
Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel
|
Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel
|
Experimental: Low dose of H5 VLP vaccine + GLA-SE
Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE
|
Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE
|
Experimental: High dose of H5 VLP vaccine + GLA-SE
Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE
|
Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE
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Placebo Comparator: Placebo comparator: Placebo
Biological: Placebo 2 doses given 21 days apart of the placebo
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Biological: Placebo 2 doses given 21 days apart of the placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus
Time Frame: 21 days after each injection
|
Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 21).
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21 days after each injection
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Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus
Time Frame: 42 days after each injection
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Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 42).
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42 days after each injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross-reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine
Time Frame: 21 days after each injection
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Measures of Geometric Mean Fold Rise, seroconversion rate and seroprotection rate (for HI only).
|
21 days after each injection
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Reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine given 21 days apart
Time Frame: 21 days after each injection
|
GMFR, seroconversion rate, percentage of subjects with a detectable MN antibody response
|
21 days after each injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Luis Robles, MD, Syneos Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
September 18, 2013
First Submitted That Met QC Criteria
November 18, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Orthomyxoviridae Infections
- Infections
- Communicable Diseases
- Virus Diseases
- Influenza, Human
- Respiratory Tract Infections
- Respiratory Tract Diseases
- RNA Virus Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunologic Factors
- Gastrointestinal Agents
- Adjuvants, Immunologic
- Antacids
- Vaccines
- Aluminum Hydroxide
Other Study ID Numbers
- CP-H5VLP-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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