UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009106 |
|---|---|
| Receipt number | R000010614 |
| Scientific Title | The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV). |
| Date of disclosure of the study information | 2012/10/14 |
| Last modified on | 2019/01/25 15:28:45 |
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Basic information
Public title
The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Acronym
Comparison of the adaptive immune responses induced by a subcutaneous annual influenza vaccine to responses induced by an intranasal vaccination using inactivated whole-virus vaccines.
Scientific Title
The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Scientific Title:Acronym
Comparison of the adaptive immune responses induced by a subcutaneous annual influenza vaccine to responses induced by an intranasal vaccination using inactivated whole-virus vaccines.
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The goal of this study is to compare adaptive immune responses in healthy volunteers receiving a trivalent annual influenza vaccine (split vaccine containing 15 ug HA/dose of influenza A/H1N1 virus, 15 ug HA/dose of influenza A/H3N2 virus and 15 ug HA/dose of influenza B virus) and those in healthy volunteers receiving a trivalent inactivated whole-virus vaccine (containing 15 or 45 ug of each HA/dose) with or without carboxy vinyl polymer (CVP), that increases the viscosity of the vaccine. Antibody responses in serum and nasal mucus, as well as B and T cell responses will be evaluated.
In addition, for volunteers who agree with the administration of a live attenuated influenza vaccine, the additional administration of FluMist will be performed three weeks after the second vaccination. Antibody responses in serum and nasal mucus, and the elimination of FluMist will be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neutralization, HI, and HA-specific antibody titers before and after intranasal vaccination.
The proportion of memory B cells or plasma cells in peripheral blood mononuclear cells, and the cytokine profile.
Key secondary outcomes
The analysis of the antibody repertoire induced by the intranasal vaccination.
Survey on side reaction after vaccination.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Subcutaneous administration of an influenza split vaccine (15 ug of each HA/dose) is performed twice with a 3 week interval. For volunteers who agree with the administration of a live attenuated influenza vaccine, the additional administration of FluMist will be performed three weeks after the second vaccination.
Interventions/Control_2
Intranasal administration of an inactivated whole-virus influenza vaccine (15 ug of each HA/dose) with CVP is performed twice with a 3 week interval. For volunteers who agree with the administration of a live attenuated influenza vaccine, the additional administration of FluMist will be performed three weeks after the second vaccination.
Interventions/Control_3
Intranasal administration of an inactivated whole-virus influenza vaccine (15 ug of each HA/dose) is performed twice with a 3 week interval. For volunteers who agree with the administration of a live attenuated influenza vaccine, the additional administration of FluMist will be performed three weeks after the second vaccination.
Interventions/Control_4
Intranasal administration of an inactivated whole-virus influenza vaccine (45 ug of each HA/dose) is performed twice with a 3 week interval. For volunteers who agree with the administration of a live attenuated influenza vaccine, the additional administration of FluMist will be performed three weeks after the second vaccination.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers who are interested in the open recruitment for our study, and agree with our study contents, as confirmed by giving their informed consent before the onset of the study.
Key exclusion criteria
1. Volunteers with a fever at the time of planned vaccination.
2. Volunteers with serious acute diseases.
3. Volunteers considered inappropriate to be inoculated with the vaccine.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Hasegawa |
Organization
National Institute of Infectious Diseases
Division name
Department of Pathology
Zip code
Address
Toyama 1-23-1, Shinjuku-ku, Tokyo
TEL
03-5285-1111
hasegawa@nih.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Hasegawa |
Organization
National Institute of Infectious Diseases
Division name
Department of Pathology
Zip code
Address
Toyama 1-23-1, Shinjuku-ku, Tokyo
TEL
03-5285-1111
Homepage URL
hasegawa@nih.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and Welfare
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
| 2012 | Year | 10 | Month | 14 | 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
| 2012 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010614
