Yellow fever vaccine dose-response study

Completed

• Conditions: Yellow fever vaccination; Infections and Infestations; Yellow fever

• Registration Number: ISRCTN38082350
• Lead Sponsor: Bio-Manguinhos/Fiocruz (Brazil)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1050

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eutralising antibodies: seroconversion and titre, during 30 days after vaccination

Secondary Outcome Measures

Name	Time	Method
1. Reactogenicity, measured with blood chemistry before vaccination, 5 days and 30 days after vaccination<br>2. Frequency of viraemia, evaluated 5 days after vaccination <br>3. Duration of immunity, measured 30 days after vaccination and one year later (9 - 15 months is acceptable)