Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults

NCT02831751 | Completed Phase 2

• 1 other identifier: CP-Q14VLP-010
• Study Type: interventional
• Target: 1,001
• Locations: 2 countries
• Sites: 15

Brief Summary

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, establish potential competitive advantages, and support the design of future studies.

Conditions

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

Keywords

Influenza; Human; RNA Virus Infections; Immulogic; Immunogenic Factors; Physiological Effects of Drug; Virus Diseases; Orthomyxoviridae Infections; Infection

Outcome Measures

Primary Outcomes (1)

• Immunogenicity assessed by the geometric mean titers (GMT) of hemagglutination inhibition (HI) antibody against the homologous influenza strains

  Immunogenicity will be assessed by the geometric mean titers (GMT)

  21 days after injection

Secondary Outcomes (7)

• Immunogenicity assessed by GMT of HI antibody against heterologous strains

  21 days after injection

• Immunogenicity assessed by GMT of microneutralization (MN) antibody against homologous and heterologous strains

  21 days after injection

• Immunogenicity assessed by GMT of single radial hemolysis (SRH) antibody against homologous and heterologous strains

  21 days after injection

• Immunogenicity assessed by cell-mediated immune (CMI) response against homologous and heterologous strains

  21 days after injection

• Incidence of Solicited Local and Systemic Reactions

  21 days after injection

Study Arms (4)

30 µg/strain of Quadrivalent VLP Vaccine

EXPERIMENTAL

Biological: 30 µg/strain of Quadrivalent VLP Vaccine

60 µg/strain of Quadrivalent VLP Vaccine

EXPERIMENTAL

Biological: 60 µg/strain of Quadrivalent VLP Vaccine

FluLaval® Tetra (15 µg/strain)

ACTIVE COMPARATOR

Biological: FluLaval® Tetra (15 µg/strain)

Fluzone® High-Dose (60 µg/strain)

ACTIVE COMPARATOR

Biological: Fluzone® High-Dose (60 µg/strain)

Interventions

30 µg/strain of Quadrivalent VLP Vaccine BIOLOGICAL

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

30 µg/strain of Quadrivalent VLP Vaccine

60 µg/strain of Quadrivalent VLP Vaccine BIOLOGICAL

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

60 µg/strain of Quadrivalent VLP Vaccine

FluLaval® Tetra (15 µg/strain) BIOLOGICAL

Single dose of a licensed quadrivalent vaccine

Also known as: FluLaval® Quadrivalent

FluLaval® Tetra (15 µg/strain)

Fluzone® High-Dose (60 µg/strain) BIOLOGICAL

Single dose of a licensed trivalent vaccine

Fluzone® High-Dose (60 µg/strain)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects must be able to read, understand, and sign the informed consent form (ICF); complete study-related procedures; and communicate with the study staff at visits and by phone.
• Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study.
• Male and female subjects must be 65 years of age or older at Screening (Visit 1).
• Subjects have a body mass index (BMI) of ≥ 18.0 and ≤ 32.4 kg/m2 at Day 0.
• Subjects must be in good general health prior to study participation (no more than 30 days prior to study vaccine administration) with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments as assessed by the Principal Investigator or Sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, biochemistry, hematology, and urinalysis.
• Note: Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the subject by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease 6 months prior to immunization. Based on the Investigator's judgment, a subject with more recent stabilization of a disease could also be eligible.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from participating in this study:
• According to the Investigator's opinion, history 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 during one month prior to study vaccine administration due to uncontrolled symptoms or drug toxicity, or for chronic diseases, significant change in medication dosage within 6 months prior to study vaccine administration based upon the investigator's judgment (elective dosage adjustments in stable subjects are acceptable).
• Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse 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 autoimmune disease other than hypothyroidism on stable replacement therapy or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, or the presence of lymphoproliferative disease.
• Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling at Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator.
• Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to randomization or planned administration prior to the completion of Day 201.
• Administration of any 'standard', non-adjuvanted influenza vaccine (e.g., live attenuated trivalent/quadrivalent inactivated influenza vaccine intranasal or split trivalent/quadrivalent inactivated influenza vaccine by either intradermal or intramuscular \[IM\] route) within 6 months prior to randomization and up to completion of Day 21 visit.
• Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to randomization or planned use during the study period. Subjects may not participate in any other investigational or marketed drug study while participating in this study until Day 201 visit.
• 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 study vaccine administration, any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within 3 months of vaccination and until the completion of Day 21 visit. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted.
• Any significant disorder of coagulation including treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g., low-dose aspirin \[no more than 325 mg/day\]), and without a clinically apparent bleeding tendency are eligible. Subjects treated with new generation drugs that do not increase the risk of intramuscular bleeding (e.g. clopidogrel) are also eligible.
• History of allergy to any of the constituents of the Quadrivalent VLP vaccine (including H1N1, H3N2, B/Bris, and B/Phuket), to any components of the licensed quadrivalent/trivalent vaccine, or tobacco allergy.
• History of anaphylactic allergic reactions to any food, medication, or bee sting.
• Any history of serious asthma (e.g., status asthmaticus, hospitalization for asthma control) or recurrent asthma episodes requiring medical attention in the last 3 years (≥ 1 episode/year)

Sponsors & Collaborators

• Medicago: lead

Study Sites (15)

Paradigm Research - Redding

Redding, California, 96001, United States

Location

Broward Research Group (BRG)

Hollywood, Florida, 33024, United States

Location

Miami Research Associates (MRA)

South Miami, Florida, 33143, United States

Location

Meridian Clinical Research - Savannah

Savannah, Georgia, 31406, United States

Location

Meridian Clinical Research - Omaha

Omaha, Nebraska, 68134, United States

Location

Regional Clinical Research (RCR)

Endwell, New York, 13760, United States

Location

INC Research Toronto

Toronto, Ontario, M5V 2T3, Canada

Location

Topstone Research

Toronto, Ontario, M9C 4Z5, Canada

Location

Manna Research

Lévis, Quebec, G6W OM5, Canada

Location

Omnispec Clinical Research

Mirabel, Quebec, J7J 2K8, Canada

Location

Diex Research Montreal

Montreal, Quebec, H2Y 1S1, Canada

Location

McGill University Health Center - Vaccine Study Center (MUHC)

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Diex Research Sherbroooke

Sherbroooke, Quebec, J1H 1Z1, Canada

Location

Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU)

Québec, G1E 7G9, Canada

Location

Centre de Recherche St-Louis

Québec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

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

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Pierre Lachance, MD

  Centre de Recherche St-Louis, Quebec, Quebec, Canada

  PRINCIPAL INVESTIGATOR

• Marc Dionne, MD

  Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU), Quebec, Quebec, Canada

  PRINCIPAL INVESTIGATOR

• Michael Libman, MD

  McGill University Health Center - Vaccine Study Center (MUHC), Montreal, Canada

  PRINCIPAL INVESTIGATOR

• Trevor Wesson, MD

  Diex Research Montreal, Montreal, Canada

  PRINCIPAL INVESTIGATOR

• Ginette Girard, MD

  Diex Research Sherbrooke, Sherbrooke, Canada

  PRINCIPAL INVESTIGATOR

• Deepen Patel, MD

  Topstone Research, Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Gérald Vallières, MD

  Manna Research, Lévis, Canada

  PRINCIPAL INVESTIGATOR

• Luis Robles, MD

  INC Research Toronto, Inc., Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Guy Tellier, MD

  Omnispec Clinical Research Inc, Mirabel, Canada

  PRINCIPAL INVESTIGATOR

• Diane R Krieger, MD

  Miami Research Associates (MRA), Miami (FL), USA

  PRINCIPAL INVESTIGATOR

• David J Seiden, MD

  Broward Research Group (BRG), Hollywood (FL), USA

  PRINCIPAL INVESTIGATOR

• Suchet R Patel, MD

  Regional Clinical Research (RCR), Endwell (NY), USA

  PRINCIPAL INVESTIGATOR

• Paul Bradley, MD

  Meridian Clinical Research, Savannah (GA), USA

  PRINCIPAL INVESTIGATOR

• Brandon J Essink, MD

  Meridian Clinical Research, Omaha (NE), USA

  PRINCIPAL INVESTIGATOR

• Jamshid Saleh, MD

  Paradigm Research, Redding (CA), USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (9)