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Virus DiseasesPhase 2NCT02233816

Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

A Phase 2 study testing Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine and High dose of quadrivalent VLP vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 2 sites in United States.

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

A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
What is being tested?
Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine and High dose of quadrivalent VLP vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
2 sitesUnited States
Study dates
28 Jul 2014to 22 Jun 2015
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 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female adults, 18 to 49 years of age, inclusive.
  • Body mass index (BMI) of ≥18 and ≤32.
  • Give his/her consent to participate in this study (by signing the informed consent form). 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.
  • Healthy as judged by the Investigator or designee and determined by complete general physical examination, vital signs, clinical laboratory tests, and medical history conducted no more than 30 days prior to study vaccine administration. 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 of 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.
  • Comprehension of the study requirements, expressed availability for the required study period, ability to attend scheduled visits, accessible by phone on a consistent basis.
  • If female, have a negative serum pregnancy test result at screening and negative urine pregnancy test on Day 0 prior to immunization.
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  • Female 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], estrogenic vaginal ring, etc.);
  • Intra-uterine device (IUD) with or without hormonal release;
  • Male partner using a condom plus spermicide or sterilized partner (at least 1 year prior to immunization);
  • Credible history of abstinence (self-reported);
  • Heterosexual abstinence at least 60 days post-immunization;
  • Female partner.
  • Non-childbearing females defines as:
  • Surgically-sterile (defined as bilateral tubal ligation or hysterectomy performed more than 1 month prior to immunization);
  • Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

Who cannot join

  • According to Investigator's opinion, 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 study vaccine administration due to uncontrolled symptoms or drug toxicity (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 or any confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection, Hepatitis B or C, or the presence of lymphoproliferative disease.
  • Administration of any vaccine (including any other influenza vaccine) within 30 days prior to study enrolment or planned administration within the period from the vaccination up to blood sampling at Day 21 or within 30 days prior to blood sampling at Day 201. Immunization on an emergency basis will be evaluated case-by-case by the Investigator.
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  • Administration of any adjuvanted or investigational influenza vaccine within 1 year prior to the study enrolment or planned administration prior to the end of this study (Day 201). Administration of any 'standard', not adjuvanted influenza vaccine (e.g.: live attenuated Trivalent Inactivated Vaccine (TIV) or Quadrivalent Inactivated Vaccine (QIV) vaccine IN or split TIV or QIV vaccine by either intra-dermal or intramuscular route) prior to the 30 day exclusion period mentioned above would be acceptable.
  • 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 investigational or marketed drug study while participating in this study (approximately 8 months).
  • 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. Low doses of nasal or inhaled glucocorticoids are allowed.
  • Any significant disorder of coagulation or 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 will not increase risk of intramuscular bleeding (such as clopidogrel) are also eligible.
  • History of allergy to any of the constituents of the VLP quadrivalent study vaccine, or to the phosphate buffered saline (PBS; used as placebo), or tobacco allergy.
  • History of anaphylactic allergic reactions to any food, medication or bee sting.
  • Any history of asthma (eg: status asthmatic, hospitalization for asthma control) or recurrent asthma episodes requiring medical attention in the last 3 years (≥ 1 episode/year).
  • Continuous use of anti-histamines in the last 4 weeks prior to immunization or use of anti-histamines 48 hours prior to study immunization.
  • Have a rash, dermatological condition, tattoos, muscle mass or any other abnormalities at injection site which may interfere with injection site reaction rating.
  • Have received a blood transfusion within 90 days prior to study vaccination.
  • If female, have a positive or doubtful pregnancy test result prior to immunization or lactating females.
  • Vital sign abnormalities (systolic blood pressure and/or diastolic blood pressure, heart rate and respiratory rate. Although a vital signs measurement is out of the acceptable ranges, a subject may be included in the study based on Investigator's judgment. 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Broward Research Group

    Hollywood, Florida, 33024

  • Miami Research Associates

    Miami, Florida, 33143

Other trials in United States

About this study

Official title: Immunogenicity, Safety, and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age.

A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

Read the detailed description

This study will be a dose escalation, cohort staggering (slow enrollment) for the 3 dose levels (low, medium or high dose level) with a placebo-controlled group:

  • Cohort 1: A first cohort of one hundred nineteen subjects (119) will be randomized; of these, seventy five (75) will be dosed with the lowest dose of the quadrivalent VLP vaccine, nineteen (19) will be dosed with the medium dose of the quadrivalent VLP vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the Data and Safety Monitoring Board (DSMB) consisting of the Principal Investigator (PI), the Sponsor's Medical Officer and three external medical experts as voting members, prior to permitting immunization with the cohort 2.
  • Cohort 2: A second cohort of one hundred subjects (100) subjects will be randomized; of these, fifty six (56) will be dosed with the medium dose of the quadrivalent VLP vaccine, nineteen (19) be dosed with the high dose of the quadrivalent VLP vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the DSMB, prior to permitting immunization with the highest dose.
  • Cohort 3: A third cohort of eighty one subjects (81) subjects will be randomized; of these fifty six (56) dosed with the high dose of the quadrivalent VLP vaccine and twenty five (25) will receive a placebo.

Three (3) and 21 days after immunization, key safety (Day 3) and immunogenicity (Day 21) data will be collected and analyzed. All subjects will be followed for safety until Day 201 (6-month follow up), regardless the phase of the study.

Being tested
Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine, High dose of quadrivalent VLP vaccine, Placebo
Keywords
Influenza, Human, RNA Virus Infections, Immunologic, Immunogenic Factors, Physiological Effects of Drugs, 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.

  • Low dose of quadrivalent VLP vaccineBiological

    A single low dose of quadrivalent VLP vaccine

  • Medium dose of quadrivalent VLP vaccineBiological

    A single medium dose of quadrivalent VLP vaccine

  • High dose of quadrivalent VLP vaccineBiological

    A single high dose of quadrivalent VLP vaccine

  • PlaceboBiological

    A single dose of placebo

Study groups in NCT02233816
Study groupRoleWhat they receive
Low dose of quadrivalent VLP vaccineExperimentalA single low dose of quadrivalent VLP vaccine
Receives: Biological: Low dose of quadrivalent VLP vaccine
Medium dose of quadrivalent VLP vaccineExperimentalA single medium dose of quadrivalent VLP vaccine
Receives: Biological: Medium dose of quadrivalent VLP vaccine
High dose of quadrivalent VLP vaccineExperimentalA single high dose of quadrivalent VLP vaccine
Receives: Biological: High dose of quadrivalent VLP vaccine
PlaceboPlacebo comparatorA single dose of Placebo
Receives: Biological: Placebo

What is being measured

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

  1. Immunogenicity (against vaccine strains)

    Immunogenicity will be assessed by Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Days 0 and 21) antibodies against the vaccine strains and assessed by measuring geometric mean fold rise, seroconversion rate and seroprotection rate. Follow up serology samples for GMTs will be collected at day 201.

    Measured: 21 days after injection

  2. Safety

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

    Measured: 21 days after injection

Secondary outcomes (1)

  1. Immunogenicity (against vaccine strains and heterologous strains)

    Immunogenicity will be assessed by Geometric mean titers (GMTs) of microneutralization (MN antibody on Days 0 and 21) antibodies against the vaccine strains and assessed by measuring Geometric mean fold rise and seroconversion rate. Cross-reactivity of antibodies induced by a single dose of the quadrivalent VLP vaccine will also be assessed and measured by HI and microneutralization (MN) antibody titers for heterologous influenza strains. This will be assessed using the measures of Geometric mean fold rise, seroconversion rate and seroprotection rate (for HI only).

    Measured: 21 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 posted8 Sep 2014 (estimated)
  2. Study start28 Jul 2014
  3. Primary completion22 Jun 2015
  4. Study completion22 Jun 2015

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02233816
Sponsor's protocol ID
CP-Q13VLP-007
Status last verified
Nov 2019
First submitted
4 Sep 2014
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Pillet S, Couillard J, Trepanier S, Poulin JF, Yassine-Diab B, Guy B, Ward BJ, Landry N. Immunogenicity and safety of a quadrivalent plant-derived virus like particle influenza vaccine candidate-Two randomized Phase II clinical trials in 18 to 49 and >/=50 years old adults. PLoS One. 2019 Jun 5;14(6):e0216533. doi: 10.1371/journal.pone.0216533. eCollection 2019.

    PubMed 31166987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose of quadrivalent VLP vaccine, Medium dose of quadrivalent VLP vaccine and High dose of quadrivalent VLP vaccine in people with Virus Diseases and RNA Virus Infections, run by Medicago at 2 sites in United States.

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 17 inclusion and 20 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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. Some participants in this study may receive a placebo. 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 (against vaccine strains) (time frame: 21 days after injection). The study lists 2 primary outcomes in all. 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 NCT02233816, which also lists 1 linked publication.

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 13 Nov 2019.

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