Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

NCT01244867 | Completed Phase 2 DMC

• 1 other identifier: CP-H5VLP-002
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Immunogenicity

  Immunogenicity Geometric mean titres: (GMTs) of hemagglutination inhibition (HI) antibody on Days 0, 21 and 42. Follow-up serology samples for GMTs will be taken at Day 228.

  21 days after each injection and 6-month follow-up period

• Safety

  Safety will be assessed by the rate and severity of solicited and unsolicited adverse events post-vaccination. A 6-month follow-up period will be performed.

  21 days after each vaccination and 6-month follow-up

Secondary Outcomes (1)

• Immunogenicity

  21 dyas after each injection

Study Arms (5)

20 microgram H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

Biological: 20 micrograms dose H5 VLP

30 micrograms H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

Biological: 30 micrograms dose H5 VLP

45 micrograms H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

Biological: 45 micrograms dose H5 VLP

45 micrograms H5 VLP vaccine

EXPERIMENTAL

Biological: 45 micrograms non-adjuvanted H5 VLP

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

20 micrograms dose H5 VLP BIOLOGICAL

2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel

20 microgram H5 VLP vaccine + Alhydrogel

30 micrograms dose H5 VLP BIOLOGICAL

2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel

30 micrograms H5 VLP vaccine + Alhydrogel

45 micrograms dose H5 VLP BIOLOGICAL

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel

45 micrograms H5 VLP vaccine + Alhydrogel

45 micrograms non-adjuvanted H5 VLP BIOLOGICAL

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine

45 micrograms H5 VLP vaccine

Placebo BIOLOGICAL

2 doses given 21 days apart of the placebo

Placebo

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 ≤ 32;
• 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 serum pregnancy test result at study entry, 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.

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 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;
• History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminum hydroxide), or the phosphate buffer;
• History of severe allergic reactions or anaphylaxis;

Sponsors & Collaborators

• Medicago: lead
• Syneos Health: collaborator

Study Sites (1)

Kendle Early Stage

Toronto, Ontario, M5V 2T3, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Edward M. Sellers, MD

  Kendle Early Stage Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

CA (1)