Unique ID issued by UMIN | UMIN000018466 |
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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 |
Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Rabies post-exposure prophylaxis by purified chik-embryo cell cultured rabies vaccine made in Japan
Japan |
Patient with animal contacts in rabies-risk countries who need rabies post-exposure prophylaxis
Infectious disease | Adult |
Others
NO
This study aimed to evaluate the
features and immunogenicity of rPEP in Japan, which is one of the rabies-free countries.
Efficacy
Confirmatory
Pragmatic
Not applicable
Antibody titers for rabies virus at the initial visits to our clinic (1st to 4th doses), and at the 5th and 6th doses.
Interventional
Single arm
Non-randomized
Open -but assessor(s) are blinded
Uncontrolled
1
Diagnosis
Device,equipment |
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
16 | years-old | <= |
Not applicable |
Male and Female
Individuals exposed to animals in foreign countries and
administered rabies vaccines for rPEP at our travel clinic.
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
70
1st name | |
Middle name | |
Last name | Kei Yamamoto |
National Center for Global Health and Medicine
Disease control and prevention center
1-21-1 Toyama, Shinjuku-ku
81-3-3202-7181
kyamamoto@ncgm.hosp.go.jp
1st name | |
Middle name | |
Last name | Kei Yamamoto |
National Center for Global Health and Medicine
Disease control and prevention center
1-21-1 Toyama, Shinjuku-ku
81-3-3202-7181
kyamamoto@ncgm.hosp.go.jp
National Center for Global Health and Medicine
National Center for Global Health and Medicine
Other
National Institute of Infectious Diseases
NO
2015 | Year | 07 | Month | 29 | Day |
Published
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.
Completed
2013 | Year | 08 | Month | 16 | Day |
2013 | Year | 09 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 05 | Month | 20 | Day |
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).
2015 | Year | 07 | Month | 29 | Day |
2015 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021225
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