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Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults

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. Identifier: NCT00984945
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : November 4, 2010
Information provided by:

Brief Summary:
The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.

Condition or disease Intervention/treatment Phase
Virus Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Biological: H5 VLP pandemic influenza vaccine 5 µg Biological: H5 VLP pandemic influenza vaccine 10 µg Biological: H5 VLP pandemic influenza vaccine 20 µg Biological: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1 Single Centre, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of Plant-based H5 VLP (Virus-like Particles), (H5N1) Pandemic Influenza Vaccine Adjuvanted With Aluminium Hydroxide and Administered to Healthy Adults 18-60 Years of Age
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Arm Intervention/treatment
Active Comparator: H5 VLP vaccine 5 µg Biological: H5 VLP pandemic influenza vaccine 5 µg
0.5 mL, IM, 2 injections 21 days apart

Active Comparator: H5 VLP vaccine 10 µg Biological: H5 VLP pandemic influenza vaccine 10 µg
0.5 mL, IM, 2 injections 21 days apart

Active Comparator: H5 VLP vaccine 20 µg Biological: H5 VLP pandemic influenza vaccine 20 µg
0.5 mL, IM, two injections 21 days apart

Placebo Comparator: Placebo (Formulation buffer) Biological: Placebo
0.5 mL, IM, two injections 21 days apart

Primary Outcome Measures :
  1. Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs. [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. The secondary objective is to evaluate the immunogenicity of two consecutive doses of plant-based H5 VLP vaccine combined with Alhydrogel®, at three dose levels: 5µg, 10µg and 20µg, compared to the placebo, combined with Alhydrogel®. [ Time Frame: 21days after each vaccination and 6-month after boost injection ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female adults, 18 to 60 years of age
  • Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, vital signs, screening laboratories and medical history conducted no more than 30 days prior to study vaccine administration
  • BMI of ≥18 and ≤29
  • Comprehension of the study requirements, expressed availability for the required study period and ability to attend scheduled visits
  • Accessible by telephone on a consistent basis
  • In the opinion of the Investigator, competence 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 and capable of child-bearing, have a negative urine pregnancy test result at study entry and agree to employ 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:

    1. Requiring a new medical or surgical treatment within one month prior to study vaccine administration
    2. 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
    3. 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 incompetent 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 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 90 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
  • History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminium hydroxide), or the phosphate buffer.
  • History of severe allergic reactions or anaphylaxis
  • History of tobacco allergy
  • 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 (confirmed by Investigator), or male condom plus spermicide. All female subjects, regardless of birth control history must provide a urine sample for pregnancy screening. Effective birth control must be used for the duration of the study. The subject must have no plan to become pregnant during the study period. Females who are post-menopausal (no spotting at all) for at least two (2) years will not require a urine pregnancy test.
  • 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
  • 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
  • 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.

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 identifier (NCT number): NCT00984945

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Canada, Quebec
MUHC Vaccine Study Centre
Pierrefonds, Quebec, Canada, H9H 4Y6
Sponsors and Collaborators
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Principal Investigator: Brian Ward, MD MUHC Vaccine Study Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Brian Ward, MUHC Vaccine Study Centre, 14770 Pierrefonds Blvd., Suite 204, Pierrefonds, Quebec, H9H 4Y6 Identifier: NCT00984945    
Other Study ID Numbers: Medicago H5VLP-001
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: April 2010
Keywords provided by Medicago:
pandemic vaccine
Virus Like Particle (VLP)
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs