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Efficacy of a Plant-derived Quadrivalent VLP Vaccine in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739112
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
Medicago

Brief Summary:
This Phase 3 study is intended to assess the relative efficacy of the Quadrivalent VLP Influenza Vaccine during the 2018-2019 influenza season compared to a licensed vaccine in elderly adults 65 years of age and older. One dose of Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine (30 μg/strain) or of Comparator (15 ug/strain) will be administered to approximately 12,120 subjects.

Condition or disease Intervention/treatment Phase
Virus Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Biological: Quadrivalent VLP Vaccine Biological: Quadrivalent Comparator Vaccine Phase 3

Detailed Description:

This randomized, observer-blind, active-controlled multicenter, Phase 3 study will be conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs for the 2018-2019 influenza virus strains.

Approximately 12,120 healthy male and female subjects aged 65 years and older will be randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately 6,060 subjects will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30 μg/strain and approximately 6,060 subjects will receive the comparator. Within the two treatment groups, subjects will be stratified by site and two age groups (65-74 years of age and 75 years of age and older in a 2:1 ratio).

Subjects will participate in this study for approximately eight to ten months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12793 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, observer-blind, active comparator-controlled, multicenter, Phase 3 efficacy study.
Masking: Single (Outcomes Assessor)
Masking Description: Surveillance personnel is blinded from IP injection
Primary Purpose: Prevention
Official Title: A Randomized, Observer-blind, Active Comparator-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-derived Quadrivalent VLP Influenza Vaccine in Adults 65 Years of Age and Older
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : May 17, 2019
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Quadrivalent VLP Vaccine
Single dose - 30 µg/strain of Quadrivalent VLP Vaccine
Biological: Quadrivalent VLP Vaccine
Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine

Active Comparator: Quadrivalent Comparator Vaccine
Single dose - 15 ug/strain of Quadrivalent Comparator Vaccine
Biological: Quadrivalent Comparator Vaccine
Single dose of a 15 ug/strain of Quadrivalent Comparator Vaccine




Primary Outcome Measures :
  1. Occurrence of protocol-defined Influenza-Like Illnesses (ILI) cause by any influenza viral type/subtype [ Time Frame: 8 months ]
    Occurrences of protocol-defined ILI due to laboratory-confirmed influenza viral type/sub-type (RT-PCR)


Secondary Outcome Measures :
  1. Occurrence of ILI cause by vaccine-matched strains [ Time Frame: 8 months ]
    Occurrences of laboratory-confirmed ILI caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccination formulation (RT-PCR and serotyping)

  2. Occurrence of protocol-defined Respiratory Illnesses (RI) cause by vaccine-matched strains [ Time Frame: 8 months ]
    Occurrences of laboratory-confirmed RI caused by vaccine-matched strains sequential RT-PCR and serotyping)

  3. Occurrence of protocol-defined Respiratory Illnesses (RI) cause by any influenza viral types/subtypes [ Time Frame: 8 months ]
    Occurrences of laboratory-confirmed RI caused by any influenza viral types/subtypes (sequential RT-PCR and serotyping)

  4. Occurrences of ILI regardless of laboratory results [ Time Frame: 8 months ]
    Occurrences of ILI post vaccination confirmed or not by laboratory testing

  5. Occurrences of solicited local and systemic reactions recorded in Diary [ Time Frame: 15 minutes post-vaccination ]
    Percentage, intensity, and relationship to vaccination of immediate complaints

  6. Occurrences of solicited local and systemic reactions recorded in Diary [ Time Frame: seven days following study vaccine administration ]
    Percentage, intensity, and relationship to vaccination of solicited local and systemic signs and symptoms

  7. Occurrences of unsolicited AEs up to 21 days post-vaccination [ Time Frame: 21 days following study vaccine administration ]
    Percentage, intensity, and relationship of TEAEs

  8. Occurrence of Serious Adverse Events (SAE) [ Time Frame: 8 months ]
    Occurrences of death and SAEs

  9. Occurrence of Adverse Events leading to withdrawal [ Time Frame: 8 months ]
    Occurrences of AEs leading to withdrawal

  10. Occurrence of New Onset of Chronic Disease (NOCD) [ Time Frame: 8 months ]
    Occurrences of NOCDs

  11. HI antibody response induced by QVLP against the homologous and heterologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    GMT of HI antibody

  12. HI antibody response induced by QVLP against the homologous and heterologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    SC rate

  13. HI antibody response induced by QVLP against the homologous and heterologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    SP rate

  14. HI antibody response induced by QVLP against the homologous and heterologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    Geometric mean fold rise.

  15. MN antibody response induced by QVLP against the homologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    GMT of MN antibody

  16. MN antibody response induced by QVLP against the homologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    SC rate of MN antibody

  17. MN antibody response induced by QVLP against the homologous influenza strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    GMFR of MN antibody

  18. SRH antibody response induced by QVLP against the homologous strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    Geometric mean area (GMA) of SRH antibody

  19. SRH antibody response induced by QVLP against the homologous strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    SC rate of SRH antibody

  20. SRH antibody response induced by QVLP against the homologous strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    SP rate of SRH antibody

  21. SRH antibody response induced by QVLP against the homologous strains in a subset of 420 subjects [ Time Frame: 21 days following study vaccine administration ]
    GMFR of SRH antibody



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
  2. Subject must have a body mass index (BMI) ≤ 35 kg/m2;
  3. 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;
  4. Male and female subjects must be 65 years of age and older at the Screening/Vaccination visit (Visit 1);
  5. Subjects must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and 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, and vital signs;

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 three months prior to vaccination. Based on the Investigator's judgment, a subject with more recent stabilization of a disease could also be eligible.

Exclusion Criteria:

  1. According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. 'Evolving' is defined as:

    • Requiring a new medical or surgical treatment during the three months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met (i.e. the Investigator can justify inclusion based upon the innocuous nature of medical/surgical events and/or treatments);
    • Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 and is appropriately justified by the Investigator.
  2. Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse that would render the subject unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the subject has been otherwise opioid-free for at least three years);
  3. Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, type 1 diabetes, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
  4. Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
  5. Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
  6. Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
  7. Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or intramuscular [IM] route) within six months prior to randomization and up to completion of the study;
  8. Use of any investigational or non-registered product within 30 days or five 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 after the study;
  9. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for ten or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
  10. Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin [no more than 100 mg/day]), and without a clinically apparent bleeding tendency are eligible. Subjects treated with new generation drugs that do not increase the risk of IM bleeding (e.g. clopidogrel) are also eligible;
  11. History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine, any components of the active comparator quadrivalent vaccine, or tobacco;
  12. History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts);
  13. Use of antihistamines within 48 hours prior to study vaccination;
  14. Daily use of large doses of medication for pain control or inflammation (e.g. opioids, nonsteroidal anti-inflammatory drugs [NSAIDs]). Use of a singular regular dose either in the morning or at bedtime would not be exclusionary;
  15. Use of prophylactic medications (e.g. acetaminophen/paracetamol, aspirin, naproxen, or ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to vaccination;
  16. Planned use of influenza antiviral treatment medication before the collection of NP swabs (e.g. oseltamivir, zanamivir, rapivab);
  17. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating;
  18. Subjects who have received a blood transfusion within 90 days prior to study vaccination;
  19. Subjects with abnormal vital signs (systolic blood pressure [BP] ≥ 150 mmHg and/or diastolic BP ≥ 95 mmHg for individuals taking antihypertensive medication and ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg for individuals not taking antihypertensive medication; heart rate [HR] ≤ 45 beats/min and ≥ 100 beats/min) evaluated by an Investigator to be clinically significant. A subject with abnormal vital signs results may be included in the study based on Investigator's judgment (e.g. a resting HR ≤ 45 in highly trained athletes);
  20. Presence of any febrile illness (including an oral temperature [OT] ≥ 38.0 ˚C within 24 hours prior to vaccination;
  21. Cancer or treatment for cancer within three years prior to study vaccine administration. Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. However, individuals with conditions such as treated and uncomplicated basal cell carcinoma of the skin or non-treated, non-disseminated local prostate cancer may be eligible;
  22. Subjects identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse) of the Investigator or any employee of Medicago (or their family members);
  23. Subjects with a history of Guillain-Barré Syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739112


Locations
Show Show 104 study locations
Sponsors and Collaborators
Medicago
Investigators
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Study Chair: Sébastien Soucy Director, Clinical Studies
Study Director: Brian Ward Medical Officer
Publications of Results:
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Responsible Party: Medicago
ClinicalTrials.gov Identifier: NCT03739112    
Other Study ID Numbers: CP-PRO-QVLP-014
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs