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Virus DiseasesPhase 1NCT02022163

Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.

A Phase 1 study testing Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel and High dose of H7 VLP vaccine + Alhydrogel in people with Virus Diseases and RNA Virus Infections, run by Medicago at 1 site in Canada.

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 trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel and High dose of H7 VLP vaccine + Alhydrogel
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
Dec 2013to Dec 2014
Phase
Phase 1
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female adults, 18 to 60 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 pregnancy test result prior to first immunization
  • Female of childbearing potential (except subjects in a monogamous 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 from Day 0 (first immunization) until at least 60 days post-second immunization and must have no plan to become pregnant from Day 0 (first immunization) until at least 60 days post-second 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
Show all 26Show fewer
  • 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 42 or within 30 days prior to blood sampling at Day 228. 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 Inactivated Vaccine (TIV) or Quadrivalent Inactivated Vaccine (QIV) within 1 year prior to study enrolment or planned administration prior to the end of this trial (Day 228)
  • 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 generally 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 previous H7N9 vaccination or a history of exposure to H7N9 virus. Any subject that was enrolled on previous H7N9 studies (except the ones that received placebo) would not be eligible
  • Are at high risk of contracting H7N9 influenza infection (e.g. poultry workers)
  • History of allergy to any of the constituents of the H7 VLP (H7N9) study vaccine, Alhydrogel® (aluminum hydroxide), 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 first immunization or use of anti-histamines 48 hours prior to each 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, positive pregnancy test results at screening, and prior to immunizations on Day 0 and Day 21
  • 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.

Canada1 site

  • Canadian Science Centre for Human and Animal Health

    Winnipeg, Manitoba, R3E 3R2

Other trials in Canada

About this study

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

Read the detailed description

This study will consist of a dose-ranging in one hundred (100) subjects who will be randomized in parallel to a 1:1:1:1:1 ratio in five (5) groups of 20 subjects to receive one intramuscular injection at Days 0 and 21 of either a low, medium or high dose of H7 VLP vaccine mixed with Alhydrogel® 0.4% (0.5 mg Aluminum per dose) or a high dose of H7 VLP alone or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80). Twenty-one (21) days after each immunization, key safety and immunogenicity data will be collected and analysed. All subjects will be followed for safety until Day 228.

Being tested
Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel, High dose of H7 VLP vaccine + Alhydrogel, High dose of H7 VLP vaccine, Placebo
Keywords
Influenza, Human, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Aluminum Hydroxide, Adjuvants, 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 H7 VLP vaccine + AlhydrogelBiological

    Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

  • Med dose of H7 VLP vaccine + AlhydrogelBiological

    Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

  • High dose of H7 VLP vaccine + AlhydrogelBiological

    High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

  • High dose of H7 VLP vaccineBiological

    High dose of H7 VLP vaccine, 2 doses given 21 days apart

  • PlaceboBiological

    Placebo, 2 doses given 21 days apart

Study groups in NCT02022163
Study groupRoleWhat they receive
Low dose of H7 VLP vaccine + AlhydrogelExperimentalBiological: Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
Receives: Biological: Low dose of H7 VLP vaccine + Alhydrogel
Med dose of H7 VLP vaccine + AlhydrogelExperimentalBiological: Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
Receives: Biological: Med dose of H7 VLP vaccine + Alhydrogel
High dose of H7 VLP vaccine + AlhydrogelExperimentalBiological: High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
Receives: Biological: High dose of H7 VLP vaccine + Alhydrogel
High dose of H7 VLP vaccineExperimentalBiological: High dose of H7 VLP vaccine, 2 doses given 21 days apart
Receives: Biological: High dose of H7 VLP vaccine
PlaceboPlacebo comparatorPlacebo, 2 doses given 21 days apart
Receives: Biological: Placebo

What is being measured

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

  1. Safety

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

    Measured: 21 days after each injection and 6-month follow-up period

  2. Immunogenicity

    Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Days 0, 21 and 42 to measure Geometric mean fold rise (GMFR) and seroconversion rates).

    Measured: 21 days after each injection

Secondary outcomes (2)

  1. Immunogenicity 2

    Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Days 0, 21 and 42 to measure seroprotection rates). Follow-up serology samples for GMTs will be taken at Day 228.

    Measured: 21 days after injection and 6-month follow up

  2. Immunogenicity 3

    Geometric mean titers (GMTs) of hemagglutination inhibition against heterologous influenza strains for cross-reactivity assessment. HI antibody on Days 0, 21 and 42 to measure seroconversion rates, GMFR and seroprotection rates. Follow-up serology samples for GMTs will be taken at Day 228.

    Measured: 21 days after each injection and 6 months follow up

Timeline

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

  1. First posted27 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionSep 2014
  4. Study completionDec 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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022163
Sponsor's protocol ID
CP-H7VLP-006
Status last verified
Sep 2015
First submitted
20 Dec 2013
Last updated
25 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel and High dose of H7 VLP vaccine + Alhydrogel in people with Virus Diseases and RNA Virus Infections, run by Medicago at 1 site in Canada.

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 26 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 25 Sep 2015. 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 Canada. 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 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.

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?

Safety (time frame: 21 days after each injection and 6-month follow-up period). 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 NCT02022163.

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 25 Sep 2015.

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