Yellow fever vaccination Infections and Infestations Yellow fever
Conditions
Interventions
Vaccination with one dose (subcutaneously [sc]) of yellow fever vaccine in current use or in five decreasing dilutions, and a placebo (placebo will receive vaccine as soon as possible):
Reference vac
Sponsors
Bio-Manguinhos/Fiocruz (Brazil)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adult men 2. Aged 18 - 30 years old 3. Healthy 4. Agree to participate after reading and understanding Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. Prior vaccination against yellow fever 2. Female 3. Use of immunosuppressor drugs in the last 12 months 4. Personal history of autoimmune diseases 5. Personal history of thymus diseases 6. Personal history of anaphylactic reactions to foods, drugs or vaccines 7. Personal history of allergy to eggs, erythromycin, canamycin or gelatin 8. Persons who received immunoglobulin, blood transfusions or blood derivatives in the last 12 months 9. Persons who received live virus vaccines or cholera vaccine in the last 30 days or who plan to receive them in the following 30 days after yellow fever vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralising antibodies: seroconversion and titre, during 30 days after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reactogenicity, measured with blood chemistry before vaccination, 5 days and 30 days after vaccination 2. Frequency of viraemia, evaluated 5 days after vaccination 3. Duration of immunity, measured 30 days after vaccination and one year later (9 - 15 months is acceptable) | — |
Countries
Brazil
Outcome results
None listed