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Virus DiseasesPhase 1/2NCT01991587

Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

A Phase 1/2 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 1 site 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 I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP 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
120 participants
Where
1 siteUnited States
Study dates
8 Oct 2013to 30 Jun 2014
Phase
Phase 1/2
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.
  • Healthy as judged by the Investigator or designee and determined by medical history, complete general 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 phone on a consistent basis.
  • Give his/her consent to participate in this study (by signing the ICF). 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.
  • If female, have a negative serum pregnancy test result prior to immunization.
  • Female of childbearing potential (except subjects in a same sex relationship), must use an effective birth control for the 28 days prior to immunization and must agree to continue employing adequate birth control measures for at least 60 days post-immunization and must have no plan to become pregnant for at least 60 days post-immunization. Highly effective birth control includes hormonal contraceptives (e.g., injectable, topical [patch], estrogenic vaginal ring, etc.), intra-uterine device (IUD), abstinence (confirmed by Investigator), or male condom plus spermicide. 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.

Who cannot join

  • 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);
  • Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration.
  • 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 incompetent 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, Hepatitis B or C, or the presence of lymphoproliferative disease.
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  • Presence of any febrile illness, oral temperature of >38.0˚C within 24 hours prior to immunization. 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 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 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 study vaccine administration. Receipt of any other emergency immunizations (e.g., rabies) will result in a case-by-case review by the medical monitor of continued participation.
  • Administration of any adjuvanted or investigational influenza vaccine other than a 'simple' seasonal Trivalent influenza vaccine (TIV) or Quadrivalent influenza vaccine (QIV) within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 201).
  • 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.
  • 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 globulin preparation within 3 months of vaccination. Low doses of nasal or inhaled glucocorticoids are allowed.
  • Use of high dose inhaled steroids or oral and parenteral high dose steroid medications. Nasal steroids 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 [≤ 325 mg/day (1 regular adult aspirin) or ≤ 81 mg/day (1 baby aspirin)], and without a clinically apparent bleeding tendency are eligible.
  • History of allergy to any of the constituents of the quadrivalent VLP study vaccine, or to the Phosphate-buffered saline (PBS) (used as placebo).
  • History of severe allergic reactions (including anaphylaxis) to any food, medication or bee sting or previous severe asthma.
  • History of tobacco allergy.
  • 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, or muscle mass 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, either known pregnancy or urine beta-human chorionic gonadotropin (β-hCG) test results consistent with pregnancy during the screening period and prior to study vaccine administration on Day 0.
  • Female subjects who are lactating.
  • Any vital sign abnormalities: systolic blood pressure, diastolic blood pressure, resting heart rate not well controlled or according to the Investigator's opinion.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Miami Research Associates

    Miami, Florida, 33143

Other trials in United States

About this study

Official title: Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent Virus-like-particle (VLP) Influenza Vaccine in Adults

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

A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP 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

The Phase 1 portion of 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 thirteen subjects (13) subjects will be randomized, of these ten (10) will be dosed with the lowest dose of the quadrivalent VLP vaccine and three (3) 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 one external medical expert, prior to permitting immunization with the medium dose level.
  • Cohort 2: A second cohort of thirteen subjects (13) subjects will be randomized; of these, ten (10) will be dosed with the medium dose of the quadrivalent VLP vaccine and three (3) 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 fourteen subjects (14) subjects will be randomized; of these ten (10) dosed with the high dose of the quadrivalent VLP vaccine and four (4) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the DSMB. If the 7-day post-immunization safety data of this cohort is satisfactory according to the DSMB review, the Phase 2 portion of the study will proceed.

The Phase 2 portion of this study will be an observer-blind, randomized, dose-ranging study of the 3 different vaccine doses or a placebo. Therefore, the remaining 20 subjects per vaccine dose will be dosed with the remaining 20 subjects of the placebo group.

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 NCT01991587
Study groupRoleWhat they receive
Low dose of quadrivalent VLP vaccineExperimentalBiological: A 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. Rate of solicited and unsolicited adverse events post-vaccination.

    Measured: 21 days after injection

  2. Severity of solicited and unsolicited adverse events post-vaccination.

    Measured: 21 days after injection

  3. Relationship to vaccination of solicited and unsolicited adverse events post-vaccination.

    Measured: 21 days after injection

Secondary outcomes (3)

  1. Serum HI response induced in subjects against the vaccine strains

    Geometric mean titers (GMTs) of hemagglutination inhibition antibodies

    Measured: 21 days after injection

  2. capacity of the quadrivalent VLP vaccine to induce specific and functional antibodies against homologous strains

    MN assay

    Measured: 21 days after injection

  3. Capacity of the quadrivalent VLP vaccine to induce cross-reactive antibodies against heterologous influenza strains

    HI and MN assays

    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 posted25 Nov 2013 (estimated)
  2. Study start8 Oct 2013
  3. Primary completion30 Jun 2014
  4. Study completion30 Jun 2014

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01991587
Sponsor's protocol ID
CP-Q12VLP-004
Status last verified
Nov 2019
First submitted
6 Nov 2013
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pillet S, Aubin E, Trepanier S, Bussiere D, Dargis M, Poulin JF, Yassine-Diab B, Ward BJ, Landry N. A plant-derived quadrivalent virus like particle influenza vaccine induces cross-reactive antibody and T cell response in healthy adults. Clin Immunol. 2016 Jul;168:72-87. doi: 10.1016/j.clim.2016.03.008. Epub 2016 Mar 14.

    PubMed 26987887

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 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 1 site 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 8 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 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Rate of solicited and unsolicited adverse events post-vaccination. (time frame: 21 days after injection). The study lists 3 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 NCT01991587, 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 11 Jun 2020.

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