Virus DiseasesPhase 1NCT00984945
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
A Phase 1 study testing H5 VLP pandemic influenza vaccine 5 µg, H5 VLP pandemic influenza vaccine 10 µg and H5 VLP pandemic influenza vaccine 20 µg in people with Virus Diseases and RNA Virus Infections, run by Medicago at 1 site in Canada.
Trial summary
The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases
- What is being tested?
- H5 VLP pandemic influenza vaccine 5 µg, H5 VLP pandemic influenza vaccine 10 µg and H5 VLP pandemic influenza vaccine 20 µg
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jul 2010
- 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
- Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, vital signs, screening laboratories and medical history conducted no more than 30 days prior to study vaccine administration
- BMI of ≥18 and ≤29
- Comprehension of the study requirements, expressed availability for the required study period and ability to attend scheduled visits
- Accessible by telephone on a consistent basis
- 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 and capable of child-bearing, have a negative urine pregnancy test result at study entry and agree to employ 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 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 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 90 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
- History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminium hydroxide), or the phosphate buffer.
- History of severe allergic reactions or anaphylaxis
- History of tobacco allergy
- 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 (confirmed by Investigator), or male condom plus spermicide. All female subjects, regardless of birth control history must provide a urine sample for pregnancy screening. Effective birth control must be used for the duration of the study. The subject must have no plan to become pregnant during the study period. Females who are post-menopausal (no spotting at all) for at least two (2) years will not require a urine pregnancy test.
- 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
- 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
- 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
1 site in 1 country.
About this study
Official title: Phase 1 Single Centre, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of Plant-based H5 VLP (Virus-like Particles), (H5N1) Pandemic Influenza Vaccine Adjuvanted With Aluminium Hydroxide and Administered to Healthy Adults 18-60 Years of Age
The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Being tested
- H5 VLP pandemic influenza vaccine 5 µg, H5 VLP pandemic influenza vaccine 10 µg, H5 VLP pandemic influenza vaccine 20 µg, Placebo
- Keywords
- pandemic vaccine, influenza, H5N1, Virus Like Particle (VLP)
- Medical subject headings
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5 VLP pandemic influenza vaccine 5 µgBiological
0.5 mL, IM, 2 injections 21 days apart
H5 VLP pandemic influenza vaccine 10 µgBiological
0.5 mL, IM, 2 injections 21 days apart
H5 VLP pandemic influenza vaccine 20 µgBiological
0.5 mL, IM, two injections 21 days apart
PlaceboBiological
0.5 mL, IM, two injections 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| H5 VLP vaccine 5 µg | Active comparator | Not described Receives: Biological: H5 VLP pandemic influenza vaccine 5 µg |
| H5 VLP vaccine 10 µg | Active comparator | Not described Receives: Biological: H5 VLP pandemic influenza vaccine 10 µg |
| H5 VLP vaccine 20 µg | Active comparator | Not described Receives: Biological: H5 VLP pandemic influenza vaccine 20 µg |
| Placebo (Formulation buffer) | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs.
Measured: 21 days
Secondary outcomes (1)
The secondary objective is to evaluate the immunogenicity of two consecutive doses of plant-based H5 VLP vaccine combined with Alhydrogel®, at three dose levels: 5µg, 10µg and 20µg, compared to the placebo, combined with Alhydrogel®.
Measured: 21days after each vaccination and 6-month after boost injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicago
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Brian Ward, MD, Principal investigator, MUHC Vaccine Study Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984945
- Sponsor's protocol ID
- Medicago H5VLP-001
- Status last verified
- Apr 2010
- First submitted
- 24 Sep 2009
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Landry N, Ward BJ, Trepanier S, Montomoli E, Dargis M, Lapini G, Vezina LP. Preclinical and clinical development of plant-made virus-like particle vaccine against avian H5N1 influenza. PLoS One. 2010 Dec 22;5(12):e15559. doi: 10.1371/journal.pone.0015559.
PubMed 21203523
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Centre, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of Plant-based H5 VLP (Virus-like Particles), (H5N1) Pandemic Influenza Vaccine Adjuvanted With Aluminium Hydroxide and Administered to Healthy Adults 18-60 Years of Age
- ClinicalTrials.gov ID
- NCT00984945
- Acronym / sponsor ID
- Medicago H5VLP-001
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Keywords
- pandemic vaccine, influenza, H5N1, Virus Like Particle (VLP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- MedicagoIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H5 VLP vaccine 5 µg | Active comparator | Biological: H5 VLP pandemic influenza vaccine 5 µg |
| H5 VLP vaccine 10 µg | Active comparator | Biological: H5 VLP pandemic influenza vaccine 10 µg |
| H5 VLP vaccine 20 µg | Active comparator | Biological: H5 VLP pandemic influenza vaccine 20 µg |
| Placebo (Formulation buffer) | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female adults, 18 to 60 years of age
- Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, vital signs, screening laboratories and medical history conducted no more than 30 days prior to study vaccine administration
- BMI of ≥18 and ≤29
- Comprehension of the study requirements, expressed availability for the required study period and ability to attend scheduled visits
- Accessible by telephone on a consistent basis
Key exclusion criteria (22 listed)
- Presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. "Uncontrolled" is defined as:
- Any medical or neuropsychiatric condition 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 or presence of lymphoproliferative disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H5 VLP pandemic influenza vaccine 5 µg0.5 mL, IM, 2 injections 21 days apart | Biological | H5 VLP vaccine 5 µg |
| H5 VLP pandemic influenza vaccine 10 µg0.5 mL, IM, 2 injections 21 days apart | Biological | H5 VLP vaccine 10 µg |
| H5 VLP pandemic influenza vaccine 20 µg0.5 mL, IM, two injections 21 days apart | Biological | H5 VLP vaccine 20 µg |
| Placebo0.5 mL, IM, two injections 21 days apart | Biological | Placebo (Formulation buffer) |
Primary outcome
Safety will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs.
Time frame: 21 days
1 secondary outcome
The secondary objective is to evaluate the immunogenicity of two consecutive doses of plant-based H5 VLP vaccine combined with Alhydrogel®, at three dose levels: 5µg, 10µg and 20µg, compared to the placebo, combined with Alhydrogel®.
Time frame: 21days after each vaccination and 6-month after boost injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
- Derived from this study: PubMed 21203523Landry N, Ward BJ, Trepanier S, Montomoli E, Dargis M, Lapini G, Vezina LP. Preclinical and clinical development of plant-made virus-like particle vaccine against avian H5N1 influenza. PLoS One. 2010 Dec 22;5(12):e15559. doi: 10.1371/journal.pone.0015559.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Ward, MD principal investigator
MUHC Vaccine Study Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H5 VLP pandemic influenza vaccine 5 µg, H5 VLP pandemic influenza vaccine 10 µg and H5 VLP pandemic influenza vaccine 20 µg 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 7 inclusion and 22 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 4 Nov 2010. 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 will be evaluated through reported adverse events, physical examination findings; clinical laboratory results and vital signs. (time frame: 21 days). 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 NCT00984945, 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 4 Nov 2010.