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Virus DiseasesPhase 2NCT02768805

Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

A Phase 2 study testing 15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine and 15 µg/strain of the licensed quadrivalent vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
What is being tested?
15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine and 15 µg/strain of the licensed quadrivalent vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
9 sitesin 2 countries
Study dates
2 Mar 2016to 26 Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 18 to 64 years of age, inclusive, 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.
  • Female subjects must have a negative serum pregnancy test result at Screening (Visit 1) and a negative urine pregnancy test at Randomization prior to immunization.
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  • Female subjects of childbearing potential must use an effective method of contraception for 1 month prior to immunization and agrees to continue employing adequate birth control measures for at least 60 days post-immunization. Moreover, she must have no plan to become pregnant for at least 2 months post-immunization. Abstinent subjects should be asked what method(s) they would use, should their circumstances change, and subjects without a well-defined plan should be excluded.
  • The following relationship or methods of contraception are considered to be effective:
  • Hormonal contraceptives (e.g., injectable, topical [patch], or estrogenic vaginal ring);
  • Intra-uterine device with or without hormonal release;
  • Male partner using a condom plus spermicide or sterilized partner (at least 1 year prior to immunization);
  • Credible self-reported history of heterosexual abstinence until at least 60 days postimmunization;
  • Female partner.
  • Non-childbearing females are defined as:
  • Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than 1 month prior to immunization); or
  • Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

Who cannot join

  • 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.
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  • 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 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)
  • Continuous use of antihistamines in the last 4 weeks prior to immunization or use of antihistamines 48 hours prior to study immunization.
  • 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. Subject discovered to have taken a prophylactic medication within the 24 hours prior to planned randomization must be delayed until at least the 24 hours period is met.
  • Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating.
  • Have received a blood transfusion within 90 days prior to study vaccination.
  • If female subject, have a positive or doubtful pregnancy test result prior to immunization or lactating females.
  • Have abnormal vital signs defined as: systolic Blood Pressure (BP) > 140 mmHg and/or diastolic BP ≥ 90mmHg, heart rate ≤ 45 beats/min and ≥ 100 beats/min. Even if one or more vital signs are out of the acceptable ranges, a subject may still be included in the study based on Investigator's judgment (e.g. a resting heart rate ≤ 45 in highly-trained athletes). Presence of any febrile illness (including oral temperature (OT) ≥ 38.0 ˚C within 24 hours prior to immunization). Such subjects may be re-evaluated for enrolment after resolution of illness.
  • Cancer or treatment for cancer within 3 years of study vaccine administration. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with treated and uncomplicated basal cell carcinoma of the skin are eligible. Person with non-treated, non-disseminated local prostate cancer are eligible.
  • 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, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study or any employees of Medicago.
  • Subject with a history of Guillain-Barre Syndrome.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Canada6 sites

  • Diex Research Montreal

    Montreal, Quebec, H2Y 1S1

  • McGill University Health Center - Vaccine Study Center (MUHC)

    Pierrefonds, Quebec, H9H 4Y6

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

    Québec, G1E 7G9

  • Centre de Recherche St-Louis

    Québec, G1W 4R4

  • Diex Research Sherbroooke

    Sherbrooke, Quebec, J1H 1Z1

  • Topstone Research

    Toronto, Ontario, M9C 4Z5

Other trials in Canada

United States3 sites

  • Regional Clinical Research (RCR)

    Endwell, New York, 13760

  • Broward Research Group (BRG)

    Hollywood, Florida, 33024

  • Miami Research Associates (MRA)

    South Miami, Florida

Other trials in United States

About this study

Official title: Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Adults 18-64 Years of Age

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 demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.

Read the detailed description

This randomized, observer-blind, multicenter, Phase 2 study will be conducted at multiple sites across the United States and Canada.

The influenza strain composition of the Quadrivalent VLP Vaccine used in this study includes 2 influenza A virus strains (A/California/7/2009 [H1N1] and A/Switzerland/9715293/2013 [H3N2]) and 2 influenza B virus strains (B/Phuket/3073/2013 [Yamagata lineage] and B/Brisbane/60/2008 [Victoria lineage]), based on the 2015-2016 recommended World Health Organization (WHO) strains for vaccination in the Northern hemisphere.

Approximately 900 healthy subjects will be randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. Subjects in each group will be stratified into 2 age strata: 18 to 49 years and 50 to 64 years in a 2:1 ratio.

Subjects will receive one intramuscular (IM) injection of their assigned vaccine:

  • 15 µg/strain of Quadrivalent VLP Vaccine, or
  • 30 µg/strain of Quadrivalent VLP Vaccine, or
  • 15 µg/strain of the licensed and commercially available quadrivalent vaccine FluLaval® Tetra.

Subjects will participate in this study for approximately 8 months, during which 5 visits will be scheduled, and phone contact will be made on Day 1, Day 8, and every 2 months thereafter for up to 6 months post-Day 21 visit (Day 201). Safety laboratory assessments will be performed at Screening, on Day 3 and within 48 hours of Day 3 results availability, for grade 3 or grade 4 abnormalities or if deemed necessary by the investigator or early termination.

Being tested
15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine, 15 µg/strain of the licensed quadrivalent vaccine
Keywords
Influenza, Human, RNA Virus Infections, Immunologic, Immunogenic Factors, Physiological Effects of Drug, Virus Diseases, Orthomyxoviridae Infections, Infection
Medical subject headings
Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Human, Orthomyxoviridae Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15 µg/strain of Quadrivalent VLP VaccineBiological

    Single dose of non-adjuvanted Quadrivalent VLP Vaccine

  • 30 µg/strain of Quadrivalent VLP VaccineBiological

    Single dose of non-adjuvanted Quadrivalent VLP Vaccine

  • 15 µg/strain of the licensed quadrivalent vaccineBiological

    Also called FluLaval® Tetra, FluLaval® Quadrivalent

    Single dose of the licensed quadrivalent vaccine

Study groups in NCT02768805
Study groupRoleWhat they receive
15 µg/strain of Quadrivalent VLP VaccineExperimentalNot described
Receives: Biological: 15 µg/strain of Quadrivalent VLP Vaccine
30 µg/strain of Quadrivalent VLP VaccineExperimentalNot described
Receives: Biological: 30 µg/strain of Quadrivalent VLP Vaccine
15 µg/strain of the licensed quadrivalent vaccineActive comparatorNot described
Receives: Biological: 15 µg/strain of the licensed quadrivalent vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) of hemagglutination inhibition (HI) antibody against the homologous influenza strains

    Measured: 21 days after injection

Secondary outcomes (7)

  1. Immunogenicity assessed by GMT of HI antibody against heterologous strains

    Immunogenicity will be assessed by GMT of HI antibody against heterologous strains

    Measured: 21 days after injection

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

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

    Measured: 21 days after injection

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

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

    Measured: 21 days after injection

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

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

    Measured: 21 days after injection

  5. Incidence of Solicited Local and Systemic Reactions

    Measured: 21 days after injection

  6. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Measured: 21 days after injection

  7. Incidence of Abnormal Clinical Laboratory Tests

    Measured: 3 days after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study start2 Mar 2016
  3. Primary completion17 May 2016
  4. Study completion26 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768805
Sponsor's protocol ID
CP-Q14VLP-009
Status last verified
Jun 2020
First submitted
1 Apr 2016
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 15 µg/strain of Quadrivalent VLP Vaccine, 30 µg/strain of Quadrivalent VLP Vaccine and 15 µg/strain of the licensed quadrivalent vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity assessed by the geometric mean titers (GMT) of hemagglutination inhibition (HI) antibody against the homologous influenza strains (time frame: 21 days after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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