InfluenzaPhase 1NCT00783926
Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
A Phase 1 study testing H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 6 sites in United States.
Trial summary
The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Pandemic Influenza
- What is being tested?
- H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2008to Jul 2009
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who
- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
- Are physically and mentally capable of participating in the study
- Are willing to refrain from blood donation for the duration of Part A of the study (until Day 42 [= 21 days after the second vaccination])
- Agree to keep a daily record of symptoms for the duration of the study
- If female and capable of bearing children - have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study.
Who cannot join
- Subjects will be excluded from participation in this study if they:
- Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine
- Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers)
- Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
- Have a Body Mass Index > 35
- Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99) while seated and at rest (measurement shall be repeated twice before subject is excluded)
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- Have clinically significant abnormal clinical laboratory values at screening as determined by the Investigator
- Have clinically significant electrocardiographic abnormalities at screening
- Test positive for HIV, HBcAb or HCV
- Suffer from any kind of immunodeficiency
- Suffer from a disease or were undergoing a form of treatment within 30 days of study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs
- Have a history of severe allergic reactions (e.g. clinically severe urticaria, allergic rhinitis, asthma) or anaphylaxis (a medical emergency caused by an acute hypersensitivity reaction involving several organ systems including, but not limited to, cardio-respiratory signs with mucosal and/or skin changes (e.g. angioedema, etc) that presents as or rapidly progresses to a severe life-threatening reaction.
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Have received any blood products (e.g. a blood transfusion or immunoglobulins within 90 days of vaccination in this study
- Have donated one or more units of blood (approximately 450 mL) or plasma within 30 days of vaccination in this study
- Have received any live vaccine within 4 weeks or an inactivated vaccine or subunit vaccine within 2 weeks prior to vaccination in this study
- Have functional or surgical asplenia
- Have a positive urine drug screen (unless the subject is currently prescribed the drug detected by a licensed health care provider and the continued administration of the drug would not otherwise exclude the subject from participation)
- Have a known or suspected problem with alcohol or drug abuse
- Were administered an investigational drug within six weeks prior to study entry
- Are concurrently participating in a clinical study that includes the administration of an investigational product
- Are a member of the team conducting this study
- Are in a dependent relationship with the study Investigator or with a study team member. Dependent relationships include close relatives (i.e. children, partner/spouse, siblings, parents) as well as employees of the Investigator or site conducting the study
- If female: are pregnant or lactating
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Across America
Dallas, Texas, 75234
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Rochester Clinical Research
Rochester, New York, 14609
Omega Medical Research
Warwick, Rhode Island, 02886
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years
The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
- Conditions
- Influenza, Pandemic Influenza
- Being tested
- H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)Biological
2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 60 subjects randomized in an equal number to six different vaccine doses Receives: Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) |
| Cohort 2 | Experimental | Following review of safety data of Cohort 1, approximately 360 additional subjects randomized in an equal number to the six different vaccine doses Receives: Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
Measured: 42 days
Secondary outcomes (1)
Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783926
- Sponsor's protocol ID
- 810801
- Status last verified
- Jul 2009
- First submitted
- 31 Oct 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years
- ClinicalTrials.gov ID
- NCT00783926
- Acronym / sponsor ID
- 810801
- Conditions
- Influenza, Pandemic Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Nov 2008 (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 objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)60 subjects randomized in an equal number to six different vaccine doses |
| Cohort 2 | Experimental | Biological: H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)Following review of safety data of Cohort 1, approximately 360 additional subjects randomized in an equal number to the six different vaccine doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who
- Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination
- Are physically and mentally capable of participating in the study
- Are willing to refrain from blood donation for the duration of Part A of the study (until Day 42 [= 21 days after the second vaccination])
Key exclusion criteria (24 listed)
- Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine
- Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers)
- Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder
- Have a Body Mass Index > 35
- Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99) while seated and at rest (measurement shall be repeated twice before subject is excluded)
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 |
|---|---|---|
| H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen)2 x 0.5 mL intramuscular injections 21 days apart (one of six different doses of hemagglutinin antigen without adjuvant) | Biological | Cohort 1, Cohort 2 |
Primary outcome
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination
Time frame: 42 days
1 secondary outcome
Frequency and severity of systemic reactions and injection site reactions after the first and second vaccinations
Time frame: 180 days
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 9 Oct 2015.
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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.
Baxter BioScience Investigator, MD study director
Baxter Healthcare Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing H5N1 Influenza Vaccine, Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted (reverse genetic reassortant/H5N1 hemagglutinin antigen) in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 6 sites 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 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
Number of subjects with an antibody response to the vaccine strain associated with protection 21 days after the second vaccination (time frame: 42 days). 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 9 Oct 2015.