FluPhase 1NCT01302990
Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults
A Phase 1 study testing Dose given at Day 0 in people with Flu, run by Medicago at 1 site in United States.
Trial summary
This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in 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
- Conditions the study is for
- Flu
- What is being tested?
- Dose given at Day 0
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Nov 2011
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adults, 18 to 49 years of age;
- Healthy as judged by the Principal Investigator (PI) or designee 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;
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- Showing a HI titer < 1/40 for the swine-origin A/California/07/2009 H1N1-like X-179A strain in sera during the screening period;
- If female and of childbearing potential, have a negative serum pregnancy test result prior vaccination. Female who are post menopausal (no spotting at all) for at least 2 years will not require a pregnancy test;
- If female and capable of childbearing, has been consistently using effective birth control for the 28 days prior to vaccination. An example of highly effective birth control is oral contraceptives, hormone implants, abstinence (confirmed by Investigator), or male condom plus spermicide. All female and of childbearing potential, must provide a serum sample for pregnancy screening. Female of child bearing potential (except subjects in a same sex relationship) must agree to continue employing adequate birth control measures for at least 60 days post vaccination and must have no plan to become pregnant for at least 60 days post vaccination;
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), or
- 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 (100.4˚F) within 24 hours prior to randomization. Such subjects may be re-evaluated for randomization 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 enrollment, or planned administration within the period from the first 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;
- Use of any investigational or non-marketed product within 30 days prior to study enrollment 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 first study vaccine administration, or any other cytotoxic or immunosuppressant drug within three months of vaccination.
- Use of any immune globulin product
- 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 [eg</= 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 H1 VLP (H1N1) study vaccine, or the phosphate buffer;
- History of allergy to egg-based vaccines such as allergy or hypersensitivity to egg proteins.
- History of severe allergic reactions or anaphylaxis or severe asthma;
- History of tobacco allergy;
- History of anti-histaminics used continuously for 4 weeks or more at any time in the past year, prior to randomization;
- Have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating;
- Have received a blood transfusion within 90 days prior to vaccination;
- If female, either known pregnancy or urine beta-human chorionic gonadotropin (ß-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 pulse rate or not well controlled and 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.
- Subject with a history of Gillian Barre Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.
- Conditions
- Flu
- Being tested
- Dose given at Day 0
- Keywords
- Influenza, Respiratory disease, Prevention
- Medical subject headings
- Influenza, Human, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose given at Day 0Biological
Dose given by intramuscular administration (0.5 mL)
| Study group | Role | What they receive |
|---|---|---|
| 5 micrograms H1 VLP | Experimental | Not described Receives: Biological: Dose given at Day 0 |
| 13 micrograms H1 VLP | Experimental | Not described Receives: Biological: Dose given at Day 0 |
| 28 micrograms H1 VLP | Experimental | Not described Receives: Biological: Dose given at Day 0 |
| 45 micrograms Fluzone | Active comparator | Not described Receives: Biological: Dose given at Day 0 |
| Placebo | Placebo comparator | Not described Receives: Biological: Dose given at Day 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination as a measure of safety and tolerability
Measured: 30 minutes after vaccination
Percentage, intensity and relationship to vaccination of solicited local and systemic signs and symptoms as a measure of safety and Tolerability
Measured: 7 days after vaccination
Percentage, intensity and relationship of solicited and unsolicited local and systemic signs and symptoms 21 days following a single dose of study vaccine as a measure of safety and tolerability
Measured: 21 days after vaccination
Occurrences of all adverse events, and serious adverse events during the study as a measure of safety and Tolerability
Measured: 6 months
Occurrences of new onset of a chronic disease (NOCD)during the study as a measure of safety and tolerability
Measured: 6 months
The number and percentage of subjects with normal and abnormal urine, haematological and biochemical values at Screening, Days 21 and 201 as a measure of safety and tolerability
Measured: 6 months
Secondary outcomes (1)
Immunogenicity
Specific antibodies: Geometric Mean Titers (GMTs) with 95% confidence interval by using the Hemagglutination-Inhibition (HI), MicroNeutralisation (MN) and the Single Radial Hemolysis (SRH) tests; To measure the increase in antibodies directed to plant-specific glycans.
Measured: 21 days and 6-month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William E Gannon, MD, Principal investigator, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302990
- Sponsor's protocol ID
- CP-H1VLP-003
- Status last verified
- Aug 2013
- First submitted
- 11 Feb 2011
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Immunogenicity of a Plant-Made H1 VLP Influenza Vaccine in Adults
- ClinicalTrials.gov ID
- NCT01302990
- Acronym / sponsor ID
- CP-H1VLP-003
- Conditions
- Flu
- Keywords
- Influenza, Respiratory disease, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MedicagoIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Feb 2011 (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.
This is a Phase 1, randomized, double-blind, active- and placebo-controlled, multicenter, dose-ranging study to evaluate the safety, tolerability and Immunogenicity of a single non-adjuvanted dose of the H1 VLP Influenza vaccine in healthy adults 18-49 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 5 micrograms H1 VLP | Experimental | Biological: Dose given at Day 0 |
| 13 micrograms H1 VLP | Experimental | Biological: Dose given at Day 0 |
| 28 micrograms H1 VLP | Experimental | Biological: Dose given at Day 0 |
| 45 micrograms Fluzone | Active comparator | Biological: Dose given at Day 0 |
| Placebo | Placebo comparator | Biological: Dose given at Day 0 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female adults, 18 to 49 years of age;
- Healthy as judged by the Principal Investigator (PI) or designee 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;
Key exclusion criteria (25 listed)
- 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), or
- Hospitalization or an event fulfilling the definition of a serious adverse event within one month prior to study vaccine administration;
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 |
|---|---|---|
| Dose given at Day 0Dose given by intramuscular administration (0.5 mL) | Biological | 13 micrograms H1 VLP, 28 micrograms H1 VLP, 45 micrograms Fluzone, 5 micrograms H1 VLP, Placebo |
Primary outcome
Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination as a measure of safety and tolerability
Time frame: 30 minutes after vaccination
Percentage, intensity and relationship to vaccination of solicited local and systemic signs and symptoms as a measure of safety and Tolerability
Time frame: 7 days after vaccination
Percentage, intensity and relationship of solicited and unsolicited local and systemic signs and symptoms 21 days following a single dose of study vaccine as a measure of safety and tolerability
Time frame: 21 days after vaccination
Occurrences of all adverse events, and serious adverse events during the study as a measure of safety and Tolerability
Time frame: 6 months
Occurrences of new onset of a chronic disease (NOCD)during the study as a measure of safety and tolerability
Time frame: 6 months
The number and percentage of subjects with normal and abnormal urine, haematological and biochemical values at Screening, Days 21 and 201 as a measure of safety and tolerability
Time frame: 6 months
1 secondary outcome
Immunogenicity
Time frame: 21 days and 6-month after 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 16 Aug 2013.
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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.
William E Gannon, MD principal investigator
Accelovance
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 Dose given at Day 0 in people with Flu, 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 9 inclusion and 25 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 16 Aug 2013. 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 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?
Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination Percentage, intensity and relationship of immediate complaints, 30 minutes post-vaccination as a measure of safety and tolerability (time frame: 30 minutes after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2013; AzTrials last refreshed its copy on 8 Nov 2026.