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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007461
Receipt No. R000008703
Scientific Title The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human.
Date of disclosure of the study information 2012/03/07
Last modified on 2014/01/21

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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.
Acronym The detection and analysis of neutralizing antibodies in nasal mucosa induced by intranasal administration of an inactivated whole-virus vaccine (H3N2 virus) in human.
Scientific Title The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human.
Scientific Title:Acronym The detection and analysis of neutralizing antibodies in nasal mucosa induced by intranasal administration of an inactivated whole-virus vaccine (H3N2 virus) in human.
Region
Japan

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

Objectives
Narrative objectives1 To assess the detection of neutralizing antibodies, hemagglutination inhibiting antibodies, and HA-specific antibodies in nasal mucus, and to measure those antibody titers in nasal mucus and serum before and after intranasal administrations of an inactivated whole-virus vaccine (H3N2 virus) that contains 3-fold amount of HA in healthy adult volunteers.
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.
Survey on side reaction after vaccination.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Inactivated whole-virus vaccine of influneza virus (3-fold concentrated HA per dose) in intranasally inoculated twice at 3 weeks interval. Side reaction survey and neutralization, HI, and HA-specific antibody titer measurement are conducted before and after vaccination in healthy adults.
Interventions/Control_2
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Healthy adult volunteers who are interested in the open requirement for our study, and who receive informed consent before this study and agree with our study contents.
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
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
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Haemagglutination inhibition (HI) and neutralization (NT) titres as well as haemagglutinin (HA) specific antibody responses were examined in 50 healthy adults aged between 22 and 69 years old after two intranasal administrations of an inactivated A/Victoria/210/2009 whole virus vaccine (45 ug HA per dose) at 3 week intervals. Serum HI titres after two-doses of the nasal vaccine showed >2.5-fold rise in the ratio of geometric mean titre upon vaccination, >40% of subjects with a >4-fold increase in titre and >70% of subjects with a titre of >1:40, all parameters associated with an effective outcome of vaccination in the criteria defined by the European Medicines Agency. Serum neutralizing antibody responses correlated with HI antibody responses, although NT titres were about two-fold higher than HI titres. These high levels of serum responses were accompanied by high levels of HI and neutralizing antibody responses in nasal mucus as measured in concentrated nasal wash samples that were about 10 times diluted compared to natural nasal mucus. Serum and nasal HI and neutralizing antibody responses consisted of HA-specific IgG and IgA antibody responses, with IgG and IgA antibodies being dominant in serum and nasal responses, respectively.

Hum Vaccin Immunother. 2013 Sep 1;9(9):1962-70. doi: 10.4161/hv.25458.
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
2010 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 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 03 Month 06 Day
Last modified on
2014 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008703

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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