Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Asclin/003/2008
Study information
Scientific title
Dose-response study of 17DD yellow fever vaccine produced by Bio-Manguinhos/Fiocruz
Acronym
Study hypothesis
Yellow fever vaccine on lower doses is effective and safe.
Ethics approval
Ethics Committee of Instituto de Pesquisa Clínica Evandro Chagas gave approval on the 10th November 2008 (ref: 0038.0.009.000-08)
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Yellow fever vaccination
Intervention
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 vaccine (in current use): approximately 60,000 PFU (approximately 12,000 MLD50)
Arm 1: approximately 20,000 PFU (approximately 4,000 MLD50)
Arm 2: approximately 6,667 PFU (approximately 1,300 MLD50)
Arm 3: approximately 2,222 PFU (approximately 450 MLD50)
Arm 4: approximately 740 PFU (approximately 150 MLD50)
Arm 5: approximately 246 PFU (approximately 50 MLD50)
Arm 6: placebo
Those who do not become protected by vaccination and the placebo group will receive one dose of the reference vaccine. Volunteers will be followed up for a month after vaccination. One year after vaccination there will be another blood collection, for evaluation of duration of immunity.
Intervention type
Drug
Phase
Not Specified
Drug names
17DD yellow fever vaccine
Primary outcome measures
Neutralising antibodies: seroconversion and titre, during 30 days after vaccination
Secondary outcome measures
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)
Overall trial start date
01/03/2009
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1050
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Brazil
Trial participating centre
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
Sponsor information
Organisation
Bio-Manguinhos/Fiocruz (Brazil)
Sponsor details
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Foundation for Scientific and Technological Development in Health (Fundação para o Desenvolvimento Científico e Tecnológico em Saúde [FIOTEC])/Oswaldo Cruz Foundation (Fundacio Oswaldo Crux [Fiocruz]) (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23364472
Publication citations
-
Results
Martins RM, Maia Mde L, Farias RH, Camacho LA, Freire MS, Galler R, Yamamura AM, Almeida LF, Lima SM, Nogueira RM, Sá GR, Hokama DA, de Carvalho R, Freire RA, Pereira Filho E, Leal Mda L, Homma A, 17DD yellow fever vaccine: a double blind, randomized clinical trial of immunogenicity and safety on a dose-response study., Hum Vaccin Immunother, 2013, 9, 4, 879-888, doi: 10.4161/hv.22982.