Bird FluPhase 1NCT01675284
A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine
A Phase 1 study testing AT-301 in people with Bird Flu and Avian Influenza, run by Medigen Biotechnology Corporation at 1 site in Taiwan.
Trial summary
The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bird Flu, Avian Influenza, Influenza A(H5N1)
- What is being tested?
- AT-301
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to May 2013
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female ≥20 and ≤60 years of age
- In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- Willing and able to comply with all required study visits and follow-up required by this protocol
- Must provide written informed consent
Who cannot join
- Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine
- Had any influenza vaccine within 6 months
- Administered with any vaccine within 30 days
- A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease
- Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months
- Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
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- Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- Receiving immunoglobulins and/or any blood products within the three months
- Acute disease at the time of enrolment
- Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance
- Breast feeding or pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells
The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.
Read the detailed description
Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and has a high mortality rate. Experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. Moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further investigations are necessary before their human safety and immunogenicity can be established. This human phase I clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted H5N1 virion influenza vaccine.
- Conditions
- Bird Flu, Avian Influenza, Influenza A(H5N1)
- Being tested
- AT-301
- Keywords
- Avian Influenza, Influenza A Virus Subtype H5N1, Inactivated H5N1 Influenza Virion Vaccine, Phase I, Preventive H5N1 vaccination
- Medical subject headings
- Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-301Biological
Inactivated H5N1 Influenza Virion Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Low Dosage AT-301 | Experimental | 7.5 µg hemagglutinin (HA) Receives: Biological: AT-301 |
| Middle Dosage AT-301 | Experimental | 15 µg hemagglutinin (HA) Receives: Biological: AT-301 |
| High Dosage AT-301 | Experimental | 30 µg hemagglutinin (HA) Receives: Biological: AT-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and symptoms solicited by vaccination
Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
Measured: A 7-day follow-up period after each vaccine administration
Signs and symptoms unsolicited by vaccination
Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
Measured: A 21-day follow-up period after each vaccine administration
Occurrence of adverse events and serious adverse events
Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.
Measured: Up to 180 days after the first vaccine administration
Secondary outcomes (3)
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Measured: Day 0
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Measured: Day 21
Serum antibody titers to H5N1 virus
Serum anti-HA antibody titers and neutralizing antibody titers.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bird 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pan-Chyr Yang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675284
- Sponsor's protocol ID
- CT-AI-11
- Status last verified
- Oct 2013
- First submitted
- 22 Aug 2012
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng A, Hsieh SM, Pan SC, Li YH, Hsieh EF, Lee HC, Lin TW, Lai KL, Chen C, Shi-Chung Chang S, Chang SC. The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine - A phase I randomized clinical trial. J Microbiol Immunol Infect. 2019 Oct;52(5):685-692. doi: 10.1016/j.jmii.2019.03.009. Epub 2019 May 18.
PubMed 31255574
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Prospective, Randomized, Open Label, Observer-Blind, Single Center Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Inactivated H5N1 Influenza Vaccine Produced in Madin-Darby Canine Kidney (MDCK) Cells
- ClinicalTrials.gov ID
- NCT01675284
- Acronym / sponsor ID
- CT-AI-11
- Conditions
- Bird Flu, Avian Influenza, Influenza A(H5N1)
- Keywords
- Avian Influenza, Influenza A Virus Subtype H5N1, Inactivated H5N1 Influenza Virion Vaccine, Phase I, Preventive H5N1 vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medigen Biotechnology CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Aug 2012 (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 focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.
Detailed description
Since 1997, avian H5N1 influenza in Southeast Asia has caused several human infections and has a high mortality rate. Experts warn that the next influenza pandemic is imminent and could be severe and prevention and control will depend on the rapid production and worldwide distribution of specific pandemic influenza candidate vaccines. An H5N1 influenza vaccine was successfully produced from whole virus grown in MDCK (Madin-Darby canine kidney) cells. These purified inactivated vaccine antigens were safe and could induce immune responses in animal studies. Moreover, when formulated in aluminum phosphate a stronger response was generated even at low doses in animals (Chong et al., 2008; Hu et al., 2008). However, further investigations are necessary before their human safety and immunogenicity can be established. This human phase I clinical study, therefore, evaluates the safety and immunogenicity of adjuvanted H5N1 virion influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dosage AT-301 | Experimental | Biological: AT-3017.5 µg hemagglutinin (HA) |
| Middle Dosage AT-301 | Experimental | Biological: AT-30115 µg hemagglutinin (HA) |
| High Dosage AT-301 | Experimental | Biological: AT-30130 µg hemagglutinin (HA) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female ≥20 and ≤60 years of age
- In good health as determined by medical history, physical examination, and clinical judgment of the investigator
- Willing and able to comply with all required study visits and follow-up required by this protocol
- Must provide written informed consent
Key exclusion criteria (11 listed)
- Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine
- Had any influenza vaccine within 6 months
- Administered with any vaccine within 30 days
- A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease
- Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months
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 |
|---|---|---|
| AT-301Inactivated H5N1 Influenza Virion Vaccine | Biological | High Dosage AT-301, Low Dosage AT-301, Middle Dosage AT-301 |
Primary outcome
Signs and symptoms solicited by vaccination
Time frame: A 7-day follow-up period after each vaccine administration
Percentage, intensity, and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each administered vaccine.
Signs and symptoms unsolicited by vaccination
Time frame: A 21-day follow-up period after each vaccine administration
Percentage, intensity, and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after each administered vaccine.
Occurrence of adverse events and serious adverse events
Time frame: Up to 180 days after the first vaccine administration
Occurrence of overall adverse events and serious adverse events up to 180 days after the first administered vaccine.
3 secondary outcomes
Serum antibody titers to H5N1 virus
Time frame: Day 0
Serum antibody titers to H5N1 virus
Time frame: Day 21
Serum antibody titers to H5N1 virus
Time frame: Day 42
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 25 Oct 2013.
- Derived from this study: PubMed 31255574Cheng A, Hsieh SM, Pan SC, Li YH, Hsieh EF, Lee HC, Lin TW, Lai KL, Chen C, Shi-Chung Chang S, Chang SC. The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine - A phase I randomized clinical trial. J Microbiol Immunol Infect. 2019 Oct;52(5):685-692. doi: 10.1016/j.jmii.2019.03.009. Epub 2019 May 18.
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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.
Pan-Chyr Yang, MD, PhD principal investigator
National Taiwan University Hospital
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 AT-301 in people with Bird Flu and Avian Influenza, run by Medigen Biotechnology Corporation at 1 site in Taiwan.
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 4 inclusion and 11 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 25 Oct 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 Taiwan. 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?
Signs and symptoms solicited by vaccination (time frame: A 7-day follow-up period after each vaccine administration). The study lists 3 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 NCT01675284, which also lists 1 linked publication.
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 25 Oct 2013.