InfluenzaPhase 1/2NCT00895544
Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults
A Phase 1/2 study testing Influenza vaccine (whole virion, Vero cell derived) in people with Influenza and Avian Influenza, run by Alachua Government Services, Inc. at 3 sites in 2 countries.
Trial summary
The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Avian Influenza
- What is being tested?
- Influenza vaccine (whole virion, Vero cell derived)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2009to Jun 2011
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female subjects will be eligible for participation in this study if they:
- are 18 to 59 years of age, inclusive, on the day of screening
- have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
- are generally 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 and follow its procedures
- agree to keep a daily record of symptoms for the duration of the study
- if female of childbearing potential: have a negative urine pregnancy test result within 24 hours prior to 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 virus or a history of vaccination with an H5N1 influenza vaccine
- are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
- currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
- have any inherited or acquired immunodeficiency
- have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry 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
Show all 16Show fewer
- have a history of severe allergic reactions or anaphylaxis
- have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating
- have received any blood products or immunoglobulins within 90 days prior to study entry
- have donated blood or plasma within 30 days prior to study entry
- have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
- have a functional or surgical asplenia
- have a known or suspected problem with alcohol or drug abuse
- were administered an investigational drug within 6 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 one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
- if female: are pregnant or lactating
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Espoon rokotetutkumusklinikka
Espoo, 02100
Etelä - Helsingin rokotetutkimusklinikka
Helsinki, 00100
Austria1 site
General Hospital of Vienna (AKH Wien), Dept. of Clinical Pharmacology
Vienna, 1090
About this study
Official title: An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule With a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 59 Years
The main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.
- Conditions
- Influenza, Avian Influenza
- Being tested
- Influenza vaccine (whole virion, Vero cell derived)
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccine (whole virion, Vero cell derived)Biological
Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360)
Influenza vaccine (whole virion, Vero cell derived)Biological
Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose B of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) Receives: Biological: Influenza vaccine (whole virion, Vero cell derived) |
| 2 | Experimental | Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) Receives: Biological: Influenza vaccine (whole virion, Vero cell derived) |
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 booster vaccination defined as titer measured by microneutralization test >= 1:20.
Measured: 21 days
Secondary outcomes (1)
Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination
Measured: at the timepoints stated above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2010
- Study completionJun 2011
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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Aichinger, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895544
- Sponsor's protocol ID
- 810802
- Status last verified
- Jul 2011
- First submitted
- 7 May 2009
- 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 1/2 Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule With a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 59 Years
- ClinicalTrials.gov ID
- NCT00895544
- Acronym / sponsor ID
- 810802
- Conditions
- Influenza, Avian Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 May 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 main objective of the study is to assess the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult population when administered according to a single prime-boost schedule.
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: Influenza vaccine (whole virion, Vero cell derived)Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose B of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) |
| 2 | Experimental | Biological: Influenza vaccine (whole virion, Vero cell derived)Day 0: Single priming vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Vietnam strain) - Day 360: Randomization to booster vaccination with Dose A of whole virion, Vero cell-derived influenza vaccine (Indonesia strain) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- are 18 to 59 years of age, inclusive, on the day of screening
- have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry
- are generally 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 and follow its procedures
- agree to keep a daily record of symptoms for the duration of the study
Key exclusion criteria (16 listed)
- have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine
- are at high risk of contracting H5N1 influenza infection (e.g. poultry workers)
- currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
- have any inherited or acquired immunodeficiency
- have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry 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
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 |
|---|---|---|
| Influenza vaccine (whole virion, Vero cell derived)Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose B (Indonesia strain) for booster vaccination (Day 360) | Biological | 1 |
| Influenza vaccine (whole virion, Vero cell derived)Dose A (Vietnam strain) for priming vaccination (Day 0) - Dose A (Indonesia strain) for booster vaccination (Day 360) | Biological | 2 |
Primary outcome
Number of subjects with antibody response to the vaccine strain associated with protection 21 days after the booster vaccination defined as titer measured by microneutralization test >= 1:20.
Time frame: 21 days
1 secondary outcome
Number of subjects with antibody response associated with protection 21, 42, 180 and 360 days after the priming vaccination and 21 days after the booster vaccination
Time frame: at the timepoints stated above
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.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Gerald Aichinger, MD study director
Baxter Healthcare Corporation
3 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 Influenza vaccine (whole virion, Vero cell derived) in people with Influenza and Avian Influenza, run by Alachua Government Services, Inc. at 3 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 7 inclusion and 16 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 3 sites in Finland, Austria. 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 booster vaccination defined as titer measured by microneutralization test >= 1:20. (time frame: 21 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.