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

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 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


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

Value
https://center6.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