InfluenzaPhase 1/2NCT00517517
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine (Whole Virion, Vero Cell Derived)
A Phase 1/2 study testing Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation in people with Influenza, run by Alachua Government Services, Inc. at 4 sites in 2 countries.
Trial summary
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2007to Feb 2008
- Phase
- Phase 1/2
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are 21 to 45 years of age, inclusive, on the day of screening
- 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
- 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
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
- Are at high 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, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Suffer from any inherited or acquired immunodeficiency
- Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
- Suffer from a disease or are 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
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- Have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré syndrome)
- Have a history of severe allergic reactions or anaphylaxis
- Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating
- Have received a blood transfusion or immunoglobulins within 90 days of study entry
- Have donated blood or plasma within 30 days of study entry
- Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
- Have undergone systemic corticoid therapy within 30 days prior to study entry
- Have a functional or surgical asplenia
- Have a known or suspected problem with alcohol or drug abuse
- Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- Are a member of the team conducting this study or are in a dependent relationship with the study Investigator. 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
4 sites in 2 countries.
4 sites in 2 countries
Hong Kong2 sites
University of Hong Kong, Queen Mary Hospital
Hong Kong
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin
Singapore2 sites
National University Hospital
Singapore, 119074
Changi General Hospital
Singapore, 529889
About this study
Official title: An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
The objectives of this Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.
- Conditions
- Influenza
- Being tested
- Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation
- Keywords
- Pandemic influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulationBiological
Subjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation |
| 2 | Experimental | Intramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation Receives: Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20
Measured: 21 days after the second vaccination (= Day 42 in the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionFeb 2008
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baxter Bio Science Investigator, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517517
- Sponsor's protocol ID
- 810701
- Status last verified
- Sep 2011
- First submitted
- 16 Aug 2007
- 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
- An Open-Label Phase I/II Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
- ClinicalTrials.gov ID
- NCT00517517
- Acronym / sponsor ID
- 810701
- Conditions
- Influenza
- Keywords
- Pandemic influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Aug 2007 (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 Phase I/II study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. Subjects will be randomized 1:1 to receive two intramuscular injections (21 days apart) of the vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review the safety data after the first and second vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulationIntramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 7.5 µg of H5N1 HA antigen per 0.5 mL in a non-adjuvanted formulation |
| 2 | Experimental | Biological: Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulationIntramuscular injection of whole virion, Vero cell-derived influenza vaccine containing 3.75 µg of H5N1 HA antigen per 0.25 mL in a non-adjuvanted formulation |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are 21 to 45 years of age, inclusive, on the day of screening
- 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
- Agree to keep a daily record of symptoms for the duration of the study
Key exclusion criteria (18 listed)
- Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza virus
- Are at high 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, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Suffer from any inherited or acquired immunodeficiency
- Test positive for Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) or Hepatitis C Virus (HCV)
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 |
|---|---|---|
| Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulationSubjects will be randomized 1:1 to receive two intramuscular injections of the whole virion, Vero cell-derived influenza vaccine containing either 3.75 mg or 7.5 mg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation on Day 0 and Day 21. | Biological | 1, 2 |
Primary outcome
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20
Time frame: 21 days after the second vaccination (= Day 42 in the study)
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 Bio Science Investigator principal investigator
Baxter Healthcare Corporation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Whole virion, Vero cell-derived influenza vaccine containing either 3.75 µg or 7.5 µg H5N1 hemagglutinin (HA) antigen in a non-adjuvanted formulation in people with Influenza, run by Alachua Government Services, Inc. at 4 sites in 2 countries.
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 6 inclusion and 18 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 4 sites in Hong Kong, Singapore. 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 combined 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.
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?
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test >= 1:20 (time frame: 21 days after the second vaccination (= Day 42 in the study)). 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.