UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002296 |
|---|---|
| Receipt number | R000002808 |
| Scientific Title | Establishment of measurement of immunity against herpesvirus |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2012/08/13 11:07:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishment of measurement of immunity against herpesvirus
Acronym
Establishment of measurement of immunity against herpesvirus
Scientific Title
Establishment of measurement of immunity against herpesvirus
Scientific Title:Acronym
Establishment of measurement of immunity against herpesvirus
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the mechanisms of the immune response against the herpesvirus infection and the herpesvirus reactivation from latency by measurement of cell-mediated and humoral immunity against herpesviruses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The ability of IFN-gamma production by viral antigen stimulation and the titer of specific antibodies for viral antigens.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
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
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of blood from healthy donors; 20ml/once, maximum 4 times.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
Nothing particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Mori |
Organization
Kobe university, Graduate school of medicine, Center for Infectious Diseases
Division name
Clinical virology
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe city, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe university, Graduate school of medicine, Center for Infectious Diseases
Division name
Clinical virology
Zip code
Address
TEL
072-641-9012
Homepage URL
Sponsor or person
Institute
Kobe university, Graduate school of medicine, Center for Infectious Diseases
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labour and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Biomedical Innovation
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 05 | Day |
Last modified on
| 2012 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002808
