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

This study has been completed.
Sponsor:
Information provided by:
Medicago
ClinicalTrials.gov Identifier:
NCT00984945
First received: September 24, 2009
Last updated: November 2, 2010
Last verified: April 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Medicago:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00984945

Locations
Canada, Quebec
MUHC Vaccine Study Centre
Pierrefonds, Quebec, Canada, H9H 4Y6
Sponsors and Collaborators
Medicago
Investigators
Principal Investigator: Brian Ward, MD MUHC Vaccine Study Centre
  More Information

No publications provided by Medicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Brian Ward, MUHC Vaccine Study Centre, 14770 Pierrefonds Blvd., Suite 204, Pierrefonds, Quebec, H9H 4Y6
ClinicalTrials.gov Identifier: NCT00984945     History of Changes
Other Study ID Numbers: Medicago H5VLP-001
Study First Received: September 24, 2009
Last Updated: November 2, 2010
Health Authority: Canada: Health Canada

Keywords provided by Medicago:
pandemic vaccine
influenza
H5N1
Virus Like Particle (VLP)

Additional relevant MeSH terms:
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Infection

ClinicalTrials.gov processed this record on August 28, 2014