Unique ID issued by UMIN | UMIN000012905 |
---|---|
Receipt number | R000015056 |
Scientific Title | Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine |
Date of disclosure of the study information | 2014/01/23 |
Last modified on | 2014/04/01 11:25:04 |
Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine
Tetravalent botulinum toxoid vaccine
Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine
Tetravalent botulinum toxoid vaccine
Japan |
botulism
Infectious disease |
Others
NO
The aim of this study is to examine the immunogenicity and safety of a tetravalent botulinum toxoid vaccine produced by a Japanese research group, and to make a basis for domestic production of botulinum toxoid vaccine.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
neutralizing antibody titers in serum obtained one month after the final (4th) shot
adverse reaction(s) appeared within a week after shot
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Prevention
Vaccine |
First phase: A research participant gets 3 intramuscular shots of the botulinum toxoid vaccine 0.5 ml at intervals of one month.
Second phase: The participant gets an additional intramuscular shot of the vaccine 0.5 ml after a year after the first shot
20 | years-old | <= |
65 | years-old | >= |
Male and Female
Healthy Japanese adults who engage in the research or production of botulinum toxin, and want to be immunized with the toxoid.
Individuals with followings are excluded:
1. history of botulism.
2. history of severe adverse reaction in past immunization shots.
3. probable or possible pregnancy, or lactation.
4. cardiovascular, renal, liver, or hematological disease, or a history of them.
5. history of epilepsy.
6. diagnosis of immunodeficiency or a close relative with congenital immunodeficiency.
7. history of anaphylaxis of food(s) or medicine(s).
8. probable or possible history of allergic reaction(s) to food(s) or medicine.
9. high possibility of allergic reaction to a component of the vaccine.
10. decision by a doctor in charge of immunization that the person is inadequate for this study.
50
1st name | |
Middle name | |
Last name | Nakaba Sugimoto |
Osaka University
Graduate School of Medicine
2-2, Yamadaoka, Suita, Osaka
06-6879-3300
sugimoto@bact.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Akihiko Yamamoto |
National Institute of Infectious Diseases
Department of Bacteriology II
4-7-1, Gakuen, Musashimurayama, Tokyo
042-848-7097
yama-aki@nih.go.jp
National Institute of Infectious Diseases
Japanese Health Science Foundation
Japan
Osaka Prefecture University
NO
大阪大学医学部附属病院[大阪府)、国立感染症研究所(東京都)、財団法人化学及血清療法研究所(熊本県)、熊本県保健環境科学研究所(熊本県)
2014 | Year | 01 | Month | 23 | Day |
Partially published
Sera of all the participants showed more than 0.02 IU/ml in neutralizing activity a month after the 4th immunization shots.
Meeting abstract:
Torii, Y., T. Kohoda, N. Sugimoto, S. Kozaki, M. Takahashi, A. Ginnaga, A. Yamamoto. Clinical study of a tetaravalent (type A, B, E, and F) botulinum toxoid vaccine in Japan. 50th Interagency Botulism Research Coordinating Committee. Annapolis, Maryland, USA, Oct. 20-23, 2013.
Completed
2011 | Year | 11 | Month | 04 | Day |
2012 | Year | 01 | Month | 26 | Day |
2014 | Year | 03 | Month | 31 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 04 | Month | 30 | Day |
2014 | Year | 09 | Month | 30 | Day |
2014 | Year | 01 | Month | 20 | Day |
2014 | Year | 04 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015056
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |