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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009106
Receipt No. 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

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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
Email 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
Email hasegawa@nih.go.jp

Sponsor
Institute National Institute of Infectious Diseases
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010614

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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