UMIN-CTR Clinical Trial

Public title

The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human.

Acronym

The analysis of antibody, B and T cell responses induced by intranasal administration of an inactivated whole-virus vaccine (A/H5N1) in human, and the characterization of secretory IgA antibodies in nasal mucus.

Scientific Title

The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human.

Scientific Title:Acronym

The analysis of antibody, B and T cell responses induced by intranasal administration of an inactivated whole-virus vaccine (A/H5N1) in human, and the characterization of secretory IgA antibodies in nasal mucus.

Region

Japan

Condition

Influenza

Classification by specialty

Infectious disease

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The goal of this study is to determine adaptive immune responses in healthy adult volunteers receiving an intranasal administration of an inactivated whole-virus vaccine (A/H5N1, 45ug HA/dose) with or without carboxy vinyl polymer (CVP), that increase the viscosity of vaccine. Antibody responses in serum and nasal mucus, B and T cell responses will be evaluated.
In addition, characterization of secretory IgA antibodies in nasal mucus and evaluation of the neutralization efficacy of those antibodies will be performed in this study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Neutralization, HI, and HA-specific antibody titers before and after intranasal vaccination.
The proportion of memory B cell or plasma cell in peripheral blood mononuclear cells, and the cytokine profile.
The analysis of the antibody repertoire induced by the intranasal vaccination.
The characterization of secretory IgA antibodies in nasal mucus.
Survey on side reaction after vaccination.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

Intranasal administration of an inactivated whole-virus vaccine (A/H5N1, 45ug HA/dose) is performed twice with a 3 week interval. About a half year later, the same vaccination will be performed once more.
For the characterization of S-IgA antibodies, a few participants will receive two additional vaccinations after the last vaccination.

Interventions/Control_2

Intranasal administration of an inactivated whole-virus vaccine (A/H5N1, 45ug HA/dose) with CVP is performed twice with a 3 week interval. About a half year later, the same vaccination will be performed once more.
For the characterization of S-IgA antibodies, a few participants will receive two additional vaccinations after the last 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

Age-lower limit

20

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

60

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

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

Institute

National Institute of Infectious Diseases

Institute

Department

Personal name

Organization

Health and Labour Sciences Research Grants

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

31

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

27

Day

Last modified on

2018

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009681