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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018466
Receipt No. R000021225
Scientific Title Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Date of disclosure of the study information 2015/07/29
Last modified on 2015/07/29

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Basic information
Public title Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Acronym Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Scientific Title Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Scientific Title:Acronym Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Region
Japan

Condition
Condition Patient with animal contacts in rabies-risk countries who need rabies post-exposure prophylaxis
Classification by specialty
Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the
features and immunogenicity of rPEP in Japan, which is one of the rabies-free countries.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Antibody titers for rabies virus at the initial visits to our clinic (1st to 4th doses), and at the 5th and 6th doses.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Blood test at the initial visit, and at 5th and 6th doses
If a subject had a low antibody titer (<0.5 IU/mL), blood tests for rabies antibody were performed 4 to 8 weeks after the 6th dose
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals exposed to animals in foreign countries and
administered rabies vaccines for rPEP at our travel clinic.
Key exclusion criteria had hypersensitivity for rabies vaccine, or
had taken 3 times pre-exposure vaccination within 2 years, or
took intradermal administration, or
post-exposure prophylaxis by Zagreb method, or
used rabies immunoglobulin
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Yamamoto
Organization National Center for Global Health and Medicine
Division name Disease control and prevention center
Zip code
Address 1-21-1 Toyama, Shinjuku-ku
TEL 81-3-3202-7181
Email kyamamoto@ncgm.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Yamamoto
Organization National Center for Global Health and Medicine
Division name Disease control and prevention center
Zip code
Address 1-21-1 Toyama, Shinjuku-ku
TEL 81-3-3202-7181
Homepage URL
Email kyamamoto@ncgm.hosp.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Institute of Infectious Diseases
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
2015 Year 07 Month 29 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 N=47 (25 male subjects)
Geometric mean titers of neutrilizing antibody for rabies were 1.90 IU/mL at 5th dose immunization (Day30) and 1.06 IU/mL at 6th dose immunization (Day90), and protection rate were 90.7% and 76.7%, respectively.
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
2013 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 20 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information 32 (68.1%) did not receive rabies post-exposure prophylaxis within 48 hours after exposure
(median, 3.0 days after exposure [IQR 1.0 to 6.5 days).

Management information
Registered date
2015 Year 07 Month 29 Day
Last modified on
2015 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021225

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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