UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018466
Receipt number 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 01:26:01

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

Value
https://center6.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