AzTrials
AzTrials

Virus DiseasesPhase 2NCT01244867

Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

A Phase 2 study testing 20 micrograms dose H5 VLP, 30 micrograms dose H5 VLP and 45 micrograms dose H5 VLP 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
Search all trials

Trial summary

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
20 micrograms dose H5 VLP, 30 micrograms dose H5 VLP and 45 micrograms dose H5 VLP
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
1 siteCanada
Study dates
Nov 2010to Sep 2011
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;
  • 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 ≤ 32;
  • 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 serum pregnancy test result at study entry, 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 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 Hepatitis B or C or presence of lymphoproliferative disease;
Show all 24Show fewer
  • 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;
  • History of allergy to any of the constituents of H5 VLP (H5N1) study vaccine, Alhydrogel® (aluminum hydroxide), or the phosphate buffer;
  • History of severe allergic reactions or anaphylaxis;
  • History of tobacco allergy;
  • History of anti-histaminics used continuously for 4 weeks or more at any time in the past year;
  • Have a rash, dermatological condition or tattoos which 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 (confirmed by Investigator), 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 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;
  • 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

1 site in 1 country.

Canada1 site

  • Kendle Early Stage

    Toronto, Ontario, M5V 2T3

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Observer-blind, Single Center, Dose-Ranging Study to Evaluate the Immunogenicity Safety and Tolerability of the H5 VLP Influenza Vaccine With or Without Alhydrogel in Healthy Adults 18-60 Years of Age.

The primary objective is to assess the immunogenicity and safety and tolerability of two consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®, compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).

Read the detailed description

An adaptive design is proposed for this phase 2 trial. Part A of this study will consist of dose-ranging in 135 subjects who will be randomized to receive one injection of either 20 µg, 30 µg or 45 µg H5 VLP Influenza vaccine combined with Alhydrogel®, or 45 µg without Alhydrogel®, or the placebo preparation, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80) at Days 0 and 21. Seven-day (7) safety data after the first immunization for subjects in all five treatment groups will be tabulated and reviewed by a panel consisting of 2 external medical advisors, prior to permitting the second immunization of vaccine/placebo for all treatment groups at Day 21 (Part A). Twenty-one (21) days after the last subject vaccine administration in Part A, all safety and immunogenicity data will be collected and analysed to determine the optimal dose level. Following selection of the optimal dose, Part B of the trial will commence and consist of administration of the selected optimal dose(s) in one hundred (100) subjects, plus administration of placebo in twenty (20) subjects (total of 120 subjects in part B). These subjects will similarly receive two vaccinations 21 days apart and will be followed in the exact same fashion as Part A, except that there will be no 7-day safety analysis. Depending on data analysis one or a maximum of two vaccine doses could be selected to be further evaluated during part B of the trial. All Part A and B subjects will be followed for safety until Day 228.

Being tested
20 micrograms dose H5 VLP, 30 micrograms dose H5 VLP, 45 micrograms dose H5 VLP, 45 micrograms non-adjuvanted H5 VLP, Placebo
Medical subject headings
Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 micrograms dose H5 VLPBiological

    2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel

  • 30 micrograms dose H5 VLPBiological

    2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel

  • 45 micrograms dose H5 VLPBiological

    2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel

  • 45 micrograms non-adjuvanted H5 VLPBiological

    2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine

  • PlaceboBiological

    2 doses given 21 days apart of the placebo

Study groups in NCT01244867
Study groupRoleWhat they receive
20 microgram H5 VLP vaccine + AlhydrogelExperimentalNot described
Receives: Biological: 20 micrograms dose H5 VLP
30 micrograms H5 VLP vaccine + AlhydrogelExperimentalNot described
Receives: Biological: 30 micrograms dose H5 VLP
45 micrograms H5 VLP vaccine + AlhydrogelExperimentalNot described
Receives: Biological: 45 micrograms dose H5 VLP
45 micrograms H5 VLP vaccineExperimentalNot described
Receives: Biological: 45 micrograms non-adjuvanted H5 VLP
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. Immunogenicity

    Immunogenicity Geometric mean titres: (GMTs) of hemagglutination inhibition (HI) antibody on Days 0, 21 and 42. Follow-up serology samples for GMTs will be taken at Day 228.

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

  2. Safety

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

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

Secondary outcomes (1)

  1. Immunogenicity

    The secondary objective is to assess the cross-reactivity of antibodies induced by two consecutive doses of H5 VLP influenza vaccine given 21 days apart, at three dose levels: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel® 1% as measured by HI antibody titers for the A/Vietnam/1203/04, A/Anhui/01/2005 and A/turkey/Turkey/1/05 H5N1 strains and as measured by MicroNeutralisation(MN) antibody titers for the A/Indonesia/5/05 and A/Vietnam/1203/04 H5N1 strains.

    Measured: 21 dyas 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 posted19 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJul 2011
  4. Study completionSep 2011

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
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244867
Sponsor's protocol ID
CP-H5VLP-002
Status last verified
Jul 2012
First submitted
15 Nov 2010
Last updated
31 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 20 micrograms dose H5 VLP, 30 micrograms dose H5 VLP and 45 micrograms dose H5 VLP 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 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 31 Jul 2012. 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 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 (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 NCT01244867.

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 31 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in