Pandemic InfluenzaPhase 1/2NCT01640691
Immunogenicity and Safety of Pandemic Influenza Vaccine in Healthy Adults
A Phase 1/2 study testing Pandemic Influenza Vaccine (H5N1) in people with Pandemic Influenza, run by Adimmune Corporation at 1 site in Taiwan.
Trial summary
The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza
- What is being tested?
- Pandemic Influenza Vaccine (H5N1)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jul 2012to Jun 2013
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A male or non-pregnant female (as indicated by a negative urine pregnancy test immediately on the day prior to first vaccine administration) between 20 to 60 years of age at the time of the first vaccination. Women of childbearing potential agree to practice highly effective birth control throughout the study (from Screening to Month 3).
- Subjects are free of obvious health problems as judged by investigator (established by medical history and physical examination) before entering the study.
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to complete all elements of the study diary.
- Subjects provide signed informed consent after receiving a detailed explanation of the study protocol prior to any study procedures.
Who cannot join
- Medical history of physician-confirmed infection with an H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
- Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers).
- Has received any other licensed vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Subject has used oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days preceding the first dose of study vaccine.
- Subject has received a blood transfusion or immunoglobulins within 90 days prior to first dose of study vaccine, or planned administration of any blood products during the study period.
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- Subject has a known allergy to eggs or other components of the study vaccine.
- Subject has a history of severe allergic reactions or anaphylaxis.
- Subject has a history of Guillain-Barré Syndrome.
- Subject has an acute illness or temperature greater than 38.0 degrees Celsius by any method within 3 days prior to each vaccination.
- Subject has confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Subject has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating.
- Evidence of substance (alcohol or drug) abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Subjects with abnormal laboratory results at screening:(1) ALT or AST > or = 1 x upper limit of normal (ULN). (2) Creatinine > or = 1 x ULN. (3) Any significant laboratory abnormality as judged by the investigator
- Females are known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first study vaccine dose, or are lactating or nursing.
- Subject has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Immunogenicity and Safety of Pandemic Influenza Vaccine, AdimFlu-W (H5N1), in Healthy Adults
The objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.
- Conditions
- Pandemic Influenza
- Being tested
- Pandemic Influenza Vaccine (H5N1)
- Keywords
- pandemic influenza, pandemic influenza vaccine, Influenza, Orthomyxoviruses, A/H5N1
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic Influenza Vaccine (H5N1)Biological
Also called AdimFlu-W (H5N1) Pandemic Influenza Vaccine
Inactivated whole-virion vaccine
- Administration route: Intramuscular Injection
- Dosing schedule: 2 injections - at Day 1 and Day 22 separately
- Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)
| Study group | Role | What they receive |
|---|---|---|
| Study vaccine (AdimFlu-W) | Experimental | 0.5 mL/dose, a total of 2 doses, 21 days apart Receives: Biological: Pandemic Influenza Vaccine (H5N1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer
The primary immune response endpoint is to evaluate the seroconversion rate (SCR) in terms of HAI assays at Day 43 (21 days after the second dose).The secondary HAI endpoints are defined as following:
- SCR for the first vaccination, at Day 22.
- Seroprotection rates (SPR) for each vaccination, at Day 22 and 43.
- The geometric mean fold rise (GMFR) for each vaccination, at Day 22 and 43.
The supportive immunogenicity endpoints of MN antibodies are SCRs, SPRs and GMFRs at Day 22 and 43.
Measured: At Day 43 (21 days after the second dose).
Secondary outcomes (1)
The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events after vaccination.
Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination.The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.
Measured: At 4 weeks after two doses of study vaccine, 4 weeks apart. Reactogenicity will be recorded for 7 days after each vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start10 Jul 2012
- Primary completion2 Jan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pandemic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adimmune Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chih-Jen Chang, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640691
- Sponsor's protocol ID
- FLUW001A
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2012
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Immunogenicity and Safety of Pandemic Influenza Vaccine, AdimFlu-W (H5N1), in Healthy Adults
- ClinicalTrials.gov ID
- NCT01640691
- Acronym / sponsor ID
- FLUW001A
- Conditions
- Pandemic Influenza
- Keywords
- pandemic influenza, pandemic influenza vaccine, Influenza, Orthomyxoviruses, A/H5N1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Adimmune CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2012 (actual)
- Primary completion
- 2 Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Jul 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 objectives of this single arm study are to evaluate the immune response and safety profiles of two injections of an inactivated whole-virion vaccine containing aluminum hydroxide adjuvant, AdimFlu-W (H5N1), against influenza A (H5N1) in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study vaccine (AdimFlu-W) | Experimental | Biological: Pandemic Influenza Vaccine (H5N1)0.5 mL/dose, a total of 2 doses, 21 days apart |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A male or non-pregnant female (as indicated by a negative urine pregnancy test immediately on the day prior to first vaccine administration) between 20 to 60 years of age at the time of the first vaccination. Women of childbearing potential agree to practice highly effective birth control throughout the study (from Screening to Month 3).
- Subjects are free of obvious health problems as judged by investigator (established by medical history and physical examination) before entering the study.
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to complete all elements of the study diary.
- Subjects provide signed informed consent after receiving a detailed explanation of the study protocol prior to any study procedures.
Key exclusion criteria (16 listed)
- Medical history of physician-confirmed infection with an H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
- Subject is at high risk of contracting H5N1 influenza infection (e.g. poultry workers).
- Has received any other licensed vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Subject has used oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs within 30 days preceding the first dose of study vaccine.
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 |
|---|---|---|
| Pandemic Influenza Vaccine (H5N1)Also: AdimFlu-W (H5N1) Pandemic Influenza VaccineInactivated whole-virion vaccine 1. Administration route: Intramuscular Injection 2. Dosing schedule: 2 injections - at Day 1 and Day 22 separately 3. Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004) | Biological | Study vaccine (AdimFlu-W) |
Primary outcome
Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer
Time frame: At Day 43 (21 days after the second dose).
The primary immune response endpoint is to evaluate the seroconversion rate (SCR) in terms of HAI assays at Day 43 (21 days after the second dose).The secondary HAI endpoints are defined as following: 1. SCR for the first vaccination, at Day 22. 2. Seroprotection rates (SPR) for each vaccination, at Day 22 and 43. 3. The geometric mean fold rise (GMFR) for each vaccination, at Day 22 and 43. The supportive immunogenicity endpoints of MN antibodies are SCRs, SPRs and GMFRs at Day 22 and 43.
1 secondary outcome
The secondary objective is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events after vaccination.
Time frame: At 4 weeks after two doses of study vaccine, 4 weeks apart. Reactogenicity will be recorded for 7 days after each vaccination.
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 Jul 2018.
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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.
Chih-Jen Chang, MD principal investigator
National Cheng-Kung 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 1/2 study testing Pandemic Influenza Vaccine (H5N1) in people with Pandemic Influenza, run by Adimmune 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 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 16 Jul 2018. 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 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?
Immunogenicity Endpoint: hemagglutination inhibition (HAI) titer and microneutralization (MN) titer (time frame: At Day 43 (21 days after the second dose).). 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 Jul 2018.