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

NCT00984945 | Completed Phase 1 DMC

• 1 other identifier: Medicago H5VLP-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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®.

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections

Keywords

pandemic vaccine; influenza; H5N1; Virus Like Particle (VLP)

Outcome Measures

Primary Outcomes (1)

• Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs.

  21 days

Secondary Outcomes (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®.

  21days after each vaccination and 6-month after boost injection

Study Arms (4)

H5 VLP vaccine 5 µg

ACTIVE COMPARATOR

Biological: H5 VLP pandemic influenza vaccine 5 µg

H5 VLP vaccine 10 µg

ACTIVE COMPARATOR

Biological: H5 VLP pandemic influenza vaccine 10 µg

H5 VLP vaccine 20 µg

ACTIVE COMPARATOR

Biological: H5 VLP pandemic influenza vaccine 20 µg

Placebo (Formulation buffer)

PLACEBO COMPARATOR

Biological: Placebo

Interventions

H5 VLP pandemic influenza vaccine 5 µg BIOLOGICAL

0.5 mL, IM, 2 injections 21 days apart

H5 VLP vaccine 5 µg

H5 VLP pandemic influenza vaccine 10 µg BIOLOGICAL

0.5 mL, IM, 2 injections 21 days apart

H5 VLP vaccine 10 µg

H5 VLP pandemic influenza vaccine 20 µg BIOLOGICAL

0.5 mL, IM, two injections 21 days apart

H5 VLP vaccine 20 µg

Placebo BIOLOGICAL

0.5 mL, IM, two injections 21 days apart

Placebo (Formulation buffer)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Medicago: lead

Study Sites (1)

MUHC Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Related Publications (1)

• Landry N, Ward BJ, Trepanier S, Montomoli E, Dargis M, Lapini G, Vezina LP. Preclinical and clinical development of plant-made virus-like particle vaccine against avian H5N1 influenza. PLoS One. 2010 Dec 22;5(12):e15559. doi: 10.1371/journal.pone.0015559.

  PMID: 21203523 DERIVED

MeSH Terms

Conditions

Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza, Human

Condition Hierarchy (Ancestors)

Infections; Orthomyxoviridae Infections

Study Officials

• Brian Ward, MD

  MUHC Vaccine Study Centre

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: November 4, 2010

Record last verified: 2010-04

Locations

CA (1)