UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001182 |
|---|---|
| Receipt number | R000001438 |
| Scientific Title | A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label) |
| Date of disclosure of the study information | 2008/06/18 |
| Last modified on | 2009/05/01 09:59:27 |
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Basic information
Public title
A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)
Acronym
A phase I/II clinical study of UMN-0501 for healthy adult males
(single center, ascending dose, open label study)
Scientific Title
A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)
Scientific Title:Acronym
A phase I/II clinical study of UMN-0501 for healthy adult males
(single center, ascending dose, open label study)
Region
| Japan |
Condition
Condition
Prevention of influenza pandemic
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety, tolerability and immunogenicity of after 2 intramuscular doses of prepandemic recombinant hemagglutinin influenza vaccine.
To investigate the immunogenicity of several UMN-0501 with different components and titer of HAI/microneutralizaion after 21 days of 2 intramuscular doses of UMN-0501.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
To investigate the safety and tolerability of 2 intramuscular doses of prepandemic recombinant hemagglutinin influenza vaccine, UMN-0501.
To investigate the HAI/microneutralizaion titer after 21 days of 2 intramuscular doses of UMN-0501.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Administration of 5µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
Interventions/Control_2
Administration of 15µg recombinant hemagglutinin.
2 vaccinations, Day 0 and Day 21
Interventions/Control_3
Administration of 15µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
Interventions/Control_4
Administration of 45µg recombinant hemagglutinin.
2 vaccinations, Day 0 and Day 21
Interventions/Control_5
Administration of 45µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult males ages 20-40 years.
Provides informed consent prior to any study procedures.
Key exclusion criteria
Plans to receive of any other licensed vaccines during study period.
Has a history of a H5 type of influenza virus infection or receipt of a H5 type influenza vaccine.
Acute fever illness (greater than 39.0C) within 2 days of vaccination.
Has a history of Guillan-Barre syndrome or ADEM.
Has a history of immunodeficient or has a close relative with congenital immune deficiency.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TETSUO NAKAYAMA |
Organization
KITASATO UNIVERSITY
KITASATO INSTITUTE FOR LIFE SCIENCES
Division name
Laboratory of Virology
Zip code
Address
5-9-1 SHIROKANE, MINATO-KU, TOKYO, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
UMN Pharma Inc.
Division name
Clinical Development Division
Zip code
Address
TEL
Homepage URL
0501clinical@umnpharma.com
Sponsor or person
Institute
UMN Pharma Inc.
Institute
Department
Personal name
Funding Source
Organization
UMN Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.who.int/vaccine_research/diseases/influenza/120209_Shu-Ichi_Kanazashi.pdf
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 10 | Day |
Last modified on
| 2009 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001438
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