Yellow fever vaccine dose-response study
| ISRCTN | ISRCTN38082350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38082350 |
| Secondary identifying numbers | Asclin/003/2008 |
- Submission date
- 28/11/2008
- Registration date
- 03/12/2008
- Last edited
- 06/02/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Reinaldo Martins
Scientific
Scientific
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
Study information
| Study design | Double-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Dose-response study of 17DD yellow fever vaccine produced by Bio-Manguinhos/Fiocruz |
| Study objectives | Yellow fever vaccine on lower doses is effective and safe. |
| Ethics approval(s) | Ethics Committee of Instituto de Pesquisa Clínica Evandro Chagas gave approval on the 10th November 2008 (ref: 0038.0.009.000-08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 17DD yellow fever vaccine |
| Primary outcome measure | 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 study start date | 01/03/2009 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Male |
| Target number of participants | 1050 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Brasil 4365
Rio de Janeiro
21040-900
Brazil
21040-900
Brazil
Sponsor information
Bio-Manguinhos/Fiocruz (Brazil)
Research organisation
Research organisation
Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil
| Website | http://www.fiocruz.br/ |
|---|---|
"ROR" |
https://ror.org/05gj5j117 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | Yes | No |
