Condition category
Infections and Infestations
Date applied
28/11/2008
Date assigned
03/12/2008
Last edited
06/02/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Reinaldo Martins

ORCID ID

Contact details

Av. Brasil 4365
Manguinhos
Rio de Janeiro
21040-900
Brazil

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

http://www.fiocruz.br/

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

  1. 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.

Additional files

Editorial Notes