InfluenzaPhase 2NCT00980447
Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults
A Phase 2 study testing UMN-0501 in people with Influenza and Virus Diseases, run by UMN Pharma Inc. at 2 sites in Japan.
Trial summary
UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004). The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Virus Diseases
- What is being tested?
- UMN-0501
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
- Males and females aged 20-40 years.
- Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.
Who cannot join
- Body Mass Index (BMI) 30 kg/m2 and above.
- Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
- Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
- Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
- Has severe allergic diseases.
- Has asthma.
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- Has a history of convulsions.
- Has a history of any serious disease.
- Known impairment of imune function.
- Known rheumatism and autoimmune disease.
- Receipt of medicines that would affect evaluation of immunogenicity.
- Receipt of any live virus vaccination or receipt of any inactivated vaccine/toxoid prior to enrollment.
- Blood donation prior to enrollment.
- Receipt of another investigation agent prior to enrollment.
- History of alcohol or drug abuse.
- Females who are pregnant or potentially childbearing or are breastfeeding.
- Ineligible subject based on the judgement of the investigator.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521
National Hospital Organization Tokyo Medical Center
Meguro-ku, Tokyo, 152-8902
About this study
Official title: A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate the Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults.
UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).
The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults.
Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.
- Conditions
- Influenza, Virus Diseases
- Being tested
- UMN-0501
- Keywords
- H5N1, Vaccine, Influenza H5N1, Avian influenza H5N1, Pandemic
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMN-0501Biological
Also called UMN-05
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart
UMN-0501Biological
Also called UMN-05
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart
UMN-0501Biological
Also called UMN-05
2 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart
| Study group | Role | What they receive |
|---|---|---|
| UMN-0501 45µg | Experimental | Recombinant H5N1 vaccine 45µg Receives: Biological: UMN-0501 |
| UMN-0501 90µg | Experimental | Recombinant H5N1 vaccine 90µg Receives: Biological: UMN-0501 |
| UMN-0501 135µg | Experimental | Recombinant H5N1 vaccine 135µg Receives: Biological: UMN-0501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus.
Measured: Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)
Frequencies of AEs including vaccine-related reactogenicity events.
Measured: Throughout study period: Day0 to 42
Secondary outcomes (1)
To explore T-cell response in the subset of subjects after each vaccination as determined by proliferation and cytokine production capacity of T-cells re-stimulate by H5N1 A/Vietnam/1203/2004 recombinant virus antigens.
Measured: Day0, Day 21 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionDec 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMN Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tetsuo Nakayama, MD, PhD, Study director, Kitasato University Kitasato Institute for Life SciencesSuminobu Ito, MD, PhD, Principal investigator, National Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980447
- Sponsor's protocol ID
- JPIP501-01a
- Status last verified
- Feb 2010
- First submitted
- 17 Sep 2009
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Blinded, Dose Escalation Study to Evaluate the Immunogenicity, Safety and Optimal Dose of Three Doses Regimen of Recombinant Influenza H5N1 Vaccine, After Two Vaccinations Given 3 Weeks Apart, in Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT00980447
- Acronym / sponsor ID
- JPIP501-01a
- Conditions
- Influenza, Virus Diseases
- Keywords
- H5N1, Vaccine, Influenza H5N1, Avian influenza H5N1, Pandemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- UMN Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 Sep 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.
UMN-0501 is a purified recombinant influenza HA vaccine (A H5N1/Vietnam/1203/2004).
The purpose of the present study is to evaluate immunogenicity, safety and optimal dose among three different doses of UMN-0501 following two same-dose vaccinations of UMN-0501 per patient with a 3 week interval between vaccination in healthy young adults.
Immunogenicity will be confirmed by both microneutralization (MN) antibody and hemagglutination inhibition (HAI) titer levels in the serums of subjects after receiving different doses of UMN-0501. There will be three dose groups with 30 subjects per group for a total of 90 healthy young adults aged 20-40 years enrolled in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UMN-0501 45µg | Experimental | Biological: UMN-0501Recombinant H5N1 vaccine 45µg |
| UMN-0501 90µg | Experimental | Biological: UMN-0501Recombinant H5N1 vaccine 90µg |
| UMN-0501 135µg | Experimental | Biological: UMN-0501Recombinant H5N1 vaccine 135µg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult as determined by medical history, physical examination, laboratory test, and clinical judgment of the investigator.
- Males and females aged 20-40 years.
- Provides signed informed consent form after received a detailed explanation of the study protocol prior to any study procedures.
Key exclusion criteria (17 listed)
- Body Mass Index (BMI) 30 kg/m2 and above.
- Has a history of a A/H5N1 influenza virus infection and subjects had received other A/H5N1 influenza vaccine.
- Has a history of allergic reaction by food and medicine including vaccine, and acute fever illness (greater than 39.0C) within 2 days of vaccination.
- Has a history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM).
- Has severe allergic diseases.
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 |
|---|---|---|
| UMN-0501Also: UMN-052 doses of recombinant H5N1 A/VN/1203/2004 vaccine 45µg three weeks apart | Biological | UMN-0501 45µg |
| UMN-0501Also: UMN-052 doses of recombinant H5N1 A/VN/1203/2004 vaccine 90µg three weeks apart | Biological | UMN-0501 90µg |
| UMN-0501Also: UMN-052 doses of recombinant H5N1 A/VN/1203/2004 vaccine 135µg three weeks apart | Biological | UMN-0501 135µg |
Primary outcome
Number of subjects who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus.
Time frame: Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)
Frequencies of AEs including vaccine-related reactogenicity events.
Time frame: Throughout study period: Day0 to 42
1 secondary outcome
To explore T-cell response in the subset of subjects after each vaccination as determined by proliferation and cytokine production capacity of T-cells re-stimulate by H5N1 A/Vietnam/1203/2004 recombinant virus antigens.
Time frame: Day0, Day 21 and 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 8 Feb 2010.
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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.
Tetsuo Nakayama, MD, PhD study director
Kitasato University Kitasato Institute for Life Sciences
Suminobu Ito, MD, PhD principal investigator
National Hospital Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UMN-0501 in people with Influenza and Virus Diseases, run by UMN Pharma Inc. at 2 sites in Japan.
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 3 inclusion and 17 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 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 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 who achieve seroconversion, seroprotection, GMTs and GMT ratio to baseline, 21 days after the 2nd vaccination defined by serum neutralizing and HAI titers against the influenza H5N1 A/Vietnam/1203/2004 virus. (time frame: Day 42: 21 days after 2nd vaccination (42 days after 1st vaccination)). The study lists 2 primary outcomes in all. 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 8 Feb 2010.