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Virus DiseasesPhase 2NCT01991561

Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

A Phase 2 study testing Low dose of H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel and High dose of H5 VLP vaccine + Alhydrogel in people with Virus Diseases and RNA Virus Infections, run by Medicago at 2 sites 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 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in 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 H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel and High dose of H5 VLP vaccine + Alhydrogel
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
2 sitesCanada
Study dates
Jun 2013to Nov 2014
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 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 and determined by medical history, 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 telephone on a regular basis;
  • In the opinion of the Investigator, ability 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 at study entry, and if capable of child bearing has been consistently using effective birth control for the 28 days prior to study entry and agree to continue employing adequate birth control measures for the duration of the study.

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 test article administration due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or
  • Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to test article administration;
  • Any medical or neuropsychiatric condition 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 confirmed or suspected immunosuppressive condition or immunodeficiency including history of human immunodeficiency virus (HIV) infection or Hepatitis B or C or presence of lymphoproliferative disease;
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  • Presence of any febrile illness, oral temperature of >38.0˚C within 24 hours of test article administration. 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 a 30 day period prior to study enrolment, or planned administration within the period from the first 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 test article administration. Receipt of any other emergency immunizations (e.g. rabies) will result in a case-by-case review of continued participation;
  • 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 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 first test article administration, or any other cytotoxic or immunosuppressant drug or any immune globulin preparation within three months of vaccination. Nasal or inhaled glucocorticoids are allowed;
  • Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically apparent bleeding tendency are eligible;
  • History of previous H5N1 vaccination or a history of exposure to H5N1 virus. Any subject that was enrolled on our previous H5 studies (except the ones that received placebo) would not be eligible;
  • Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);
  • History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminum hydroxide), GLA-SE, or the phosphate buffer;
  • History of severe allergic reactions (including anaphylaxis) to any food, medication, or bee sting or previous status of asthmatic;
  • History of tobacco allergy;
  • History of egg allergy (). GLA-SE contains egg phosphatidylcholine.
  • Continuous use of anti-histamines in last 4 weeks prior to immunization and use of antihistamine in last 48 hours prior to immunization;
  • Have a rash, dermatological condition or tattoos or a muscle mass condition at the injection site that may interfere with injection site reaction rating. ;
  • Have received a blood transfusion or immunoglobulins within 90 days of study entry;
  • If female, and of childbearing potential, has not been consistently using effective birth control for the 28 days prior to study entry. An example of highly effective birth control is oral contraceptives, hormone implants, abstinence (self-reported), or male condom plus spermicide. All female subjects, regardless of birth control history must provide a serum sample for pregnancy screening. Effective birth control must be used for the duration of the study for female of child bearing potential. The subject must have no plan to become pregnant during the study period;
  • Among female subjects, either known pregnancy or urine beta-human chorionic gonadotropin (ß-hCG) test results consistent with pregnancy prior to test article administration on Day 0 and 21;
  • Female subjects who are lactating;
  • Vital sign abnormalities: systolic blood pressure >150 mmHg, diastolic blood pressure >90 mmHg, resting pulse rate <40 bpm or >100 bpm or according to the Investigator's opinion;
  • Cancer or treatment for cancer within 3 years of test article 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

2 sites in 1 country.

Canada2 sites

  • MUHC Vaccine Study Center

    Pierrefonds, Quebec, H9H4Y6

  • INC Research

    Toronto, Ontario, M5V2T3

Other trials in Canada

About this study

Official title: Immunogenicity, Safety, Tolerability of a Plant-made H5 VLP Influenza Vaccine.

A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in healthy adults 18-60 years of age.

Read the detailed description

This study will consist of a dose-ranging in 390 subjects who will be randomized to receive one injection at Days 0 and 21 of either a low, medium or a high dose of H5 VLP Influenza vaccine combined with Alhydrogel®, or a low or high dose of H5 VLP Influenza vaccine combined with GLA-SE, or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM Sodium Chloride (NaCl) + 0.01% Tween 80). Seven-day (7) safety data after the first immunization of the first 25% study subjects enrolled (98 subjects) will be tabulated and reviewed by the Data and Safety Monitoring Board (DSMB), prior to permitting the first immunization of the remaining study subjects and the second immunisations. Also, based on medical expert opinion and on safety criteria defined in the protocol, a DSMB review might be necessary on the seven-day safety data of the same 25% study subjects following administration of their second dose, before proceeding to the second immunizations of the remaining study subjects. 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 407.

Being tested
Low dose of H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel, High dose of H5 VLP vaccine + Alhydrogel, Low dose of H5 VLP vaccine + GLA-SE, High dose of H5 VLP vaccine + GLA-SE
Keywords
Influenza, Human, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Aluminum Hydroxide, Adjuvants, Immunologic, Immunogenic Factors, GLA-SE, 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 H5 VLP vaccine + AlhydrogelBiological

    Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel

  • Med dose of H5 VLP vaccine + AlhydrogelBiological

    Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel

  • High dose of H5 VLP vaccine + AlhydrogelBiological

    Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel

  • Low dose of H5 VLP vaccine + GLA-SEBiological

    Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE

  • High dose of H5 VLP vaccine + GLA-SEBiological

    Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE

  • Placebo comparator: PlaceboBiological

    Biological: Placebo 2 doses given 21 days apart of the placebo

Study groups in NCT01991561
Study groupRoleWhat they receive
Low dose of H5 VLP vaccine + AlhydrogelExperimentalBiological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel
Receives: Biological: Low dose of H5 VLP vaccine + Alhydrogel
Med dose H5 VLP vaccine + AlhydrogelExperimentalBiological:Med dose of H5 VLP vaccine + Alhydrogel, 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel
Receives: Biological: Med dose of H5 VLP vaccine + Alhydrogel
High dose of H5 VLP vaccine + AlhydrogelExperimentalBiological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel
Receives: Biological: High dose of H5 VLP vaccine + Alhydrogel
Low dose of H5 VLP vaccine + GLA-SEExperimentalBiological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE
Receives: Biological: Low dose of H5 VLP vaccine + GLA-SE
High dose of H5 VLP vaccine + GLA-SEExperimentalBiological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE
Receives: Biological: High dose of H5 VLP vaccine + GLA-SE
Placebo comparator: PlaceboPlacebo comparatorBiological: Placebo 2 doses given 21 days apart of the placebo
Receives: Biological: Placebo comparator: Placebo

What is being measured

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

  1. Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus

    Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 21).

    Measured: 21 days after each injection

  2. Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus

    Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 42).

    Measured: 42 days after each injection

Secondary outcomes (2)

  1. Cross-reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine

    Measures of Geometric Mean Fold Rise, seroconversion rate and seroprotection rate (for HI only).

    Measured: 21 days after each injection

  2. Reactivity of antibodies induced by 2 consecutive doses of H5 VLP influenza vaccine given 21 days apart

    GMFR, seroconversion rate, percentage of subjects with a detectable MN antibody response

    Measured: 21 days after each 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 startJun 2013
  3. Primary completionJul 2014
  4. Study completionNov 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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01991561
Sponsor's protocol ID
CP-H5VLP-005
Status last verified
Sep 2015
First submitted
18 Sep 2013
Last updated
11 Jun 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose of H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel and High dose of H5 VLP vaccine + Alhydrogel in people with Virus Diseases and RNA Virus Infections, run by Medicago at 2 sites 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 7 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 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 2 sites 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 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?

Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus (time frame: 21 days after each 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 NCT01991561.

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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