Inoculation with H5N1 prepandemic vaccines
Conditions
Interventions
Vaccination: twice Interval: 3 weeks Amouunt: 0.5 ml Blood collection: before vaccination and 1 month later after the 2nd vaccination
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Japanese persons who consent to participation in this study after comprehension of the study.
Exclusion criteria
Exclusion criteria: 1) A person who clearly had a history of anaphylaxis to food or drugs. 2) A person who possibly have allergy to chicken eggs, chicken meet, and something derived from chicken. 3) A person who was diagnosed with immunodeficiency syndrome, or who has relatives with congenital immunodeficiency. 4) A person who has severe cardiovascular, hematological, respiratory, hepatic, renal, gastrointestinal, or psychoneuronal disorders. 5) A person who has previous history of Guillain-Barre syndrome or acute disseminated encephalomyelitis (ADEM). 6) A person with respiratory diseases including interstitial pneumonia or bronchial asthma. 7) A person who received investigational and experimental drugs for other clinical trials within 4 months of entry. 8) A person who received live attenuated vaccines within 27 days of entry or inactivated vaccines and toxoids within 6 days of entry. 9) A person who is pregnant, is suspected to be pregnant, or a woman with breast-feeding. 10) A woman who received intravenous immunoglobulin (IVIG) or blood transfusion within 3 months of entry or who received IVIG more than 200 mg/kg within 6 months of entry. 11) A person whom researchers and doctors in charge of this study judge unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cross-reactivity of anti-hemagglutinin antibodies with hemagglutinins of H5N1 influenza viruses about 7 weeks after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of inoculation with H5N1 prepandemic vaccines. Systemic reactions: fever of more than 37.5 degree celsius, headache, general fatigue. Local reactions at inoculated site: redness, swelling, induration, pain, heat sensation, itching. | — |
Countries
Japan
Contacts
Public ContactYoshikazu Kurosawa
Fujita Health University Center for Research Promotion and Support
Outcome results
None listed