UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Title of the study (Brief title)	The analysis of antibody responses induced by intranasal vaccination with inactivated whole-virus vaccines.
Region	Japan

Condition
Condition	Influenza
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The goal of this study is to measure antibody responses in healthy volunteers receiving an intranasal vaccination with trivalent inactivated whole-virus vaccine (containing 45 ug HA/dose of influenza A/H1N1 virus, 45 ug HA/dose of influenza A/H3N2 virus and 45 ug HA/dose of influenza B virus) in the presence of carboxy vinyl polymer (CVP), that increase the viscosity of vaccine. The influence of nasal wash held one day before or just prior to the administration is estimated. In addition, the analysis of antibodies secreted on the surface of nasal mucosa is performed.
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 analysis of antibodies secreted on the surface of nasal mucosa. Survey on side reaction after vaccination.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	Intranasal administration of inactivated whole-virus influenza vaccines (each 45 ug HA/dose) with CVP is performed twice with a 3 week interval. The collection of nasal wash samples is performed one day before each administration. For volunteers who agree with the analysis of antibodies secreted on the surface of nasal mucosa, additional collection of nasal wash samples will be performed 3 weeks after the second intranasal vaccination.
Interventions/Control_2	Intranasal administration of inactivated whole-virus influenza vaccines (each 45 ug HA/dose) with CVP is performed twice with a 3 week interval. The collection of nasal wash samples is performed just prior to each administration. For volunteers who agree with the analysis of antibodies secreted on the surface of nasal mucosa, additional collection of nasal wash samples will be performed 3 weeks after the second intranasal vaccination.
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	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 vaccine.
Target sample size	50

Research contact person
Name of lead principal investigator	Hideki Hasegawa
Organization	National Institute of Infectious Diseases
Division name	Department of Pathology
Address	Toyama 1-23-1, Shinjuku-ku, Tokyo
TEL	03-5285-1111
Email	hasegawa@nih.go.jp

Public contact
Name of contact person	Hideki Hasegawa
Organization	National Institute of Infectious Diseases
Division name	Department of Pathology
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
Name of secondary funｄer(s)

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	2014 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 30 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=R000015099