Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

NCT01991561 | Completed Phase 2 DMC

• 1 other identifier: CP-H5VLP-005
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Influenza, Human; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Aluminum Hydroxide; Adjuvants, Immunologic; Immunogenic Factors; GLA-SE; Physiological Effects of Drugs; Virus Diseases; Orthomyxoviridae Infections; Infection

Outcome Measures

Primary Outcomes (2)

• Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus

  Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 21).

  21 days after each injection

• Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus

  Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 42).

  42 days after each injection

Secondary Outcomes (2)

• Cross-reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine

  21 days after each injection

• Reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine given 21 days apart

  21 days after each injection

Study Arms (6)

Low dose of H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

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 + Alhydrogel

Med dose H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

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 + Alhydrogel

High dose of H5 VLP vaccine + Alhydrogel

EXPERIMENTAL

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 + Alhydrogel

Low dose of H5 VLP vaccine + GLA-SE

EXPERIMENTAL

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 + GLA-SE

High dose of H5 VLP vaccine + GLA-SE

EXPERIMENTAL

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 + GLA-SE

Placebo comparator: Placebo

PLACEBO COMPARATOR

Biological: Placebo 2 doses given 21 days apart of the placebo

Biological: Placebo comparator: Placebo

Interventions

Low dose of H5 VLP vaccine + Alhydrogel BIOLOGICAL

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel

Low dose of H5 VLP vaccine + Alhydrogel

Med dose of H5 VLP vaccine + Alhydrogel BIOLOGICAL

Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel

Med dose H5 VLP vaccine + Alhydrogel

High dose of H5 VLP vaccine + Alhydrogel BIOLOGICAL

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel

High dose of H5 VLP vaccine + Alhydrogel

Low dose of H5 VLP vaccine + GLA-SE BIOLOGICAL

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE

Low dose of H5 VLP vaccine + GLA-SE

High dose of H5 VLP vaccine + GLA-SE BIOLOGICAL

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE

High dose of H5 VLP vaccine + GLA-SE

Placebo comparator: Placebo BIOLOGICAL

Biological: Placebo 2 doses given 21 days apart of the placebo

Placebo comparator: 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, 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.

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 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;

Sponsors & Collaborators

• Medicago: lead
• Syneos Health: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (2)

INC Research

Toronto, Ontario, M5V2T3, Canada

Location

MUHC Vaccine Study Center

Pierrefonds, Quebec, H9H4Y6, Canada

Location

MeSH Terms

Conditions

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

Interventions

Aluminum Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Michael Libman, MD

  MUHC-Vaccine Study Centre

  PRINCIPAL INVESTIGATOR

• Luis Robles, MD

  Syneos Health

  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: September 18, 2013
• First Posted: November 25, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 11, 2020

Record last verified: 2015-09

Locations

CA (2)