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)	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	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	International University of Health and Welfare
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	2012 Year 10 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 05 Day
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

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Publication of results	Unpublished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