botulism
Conditions
Interventions
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 o
Sponsors
National Institute of Infectious Diseases
Osaka Prefecture University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Japanese adults who engage in the research or production of botulinum toxin, and want to be immunized with the toxoid.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neutralizing antibody titers in serum obtained one month after the final (4th) shot | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse reaction(s) appeared within a week after shot | — |
Countries
Japan
Contacts
Public ContactAkihiko Yamamoto
National Institute of Infectious Diseases Department of Bacteriology II
Outcome results
None listed