UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007461 |
|---|---|
| Receipt number | 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 20:59:02 |
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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
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
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
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008703
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