An observational study in Yellow Fever, sponsored by Oswaldo Cruz Foundation. Status unknown at 1 site in Brazil. Open to participants aged 9 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by Oswaldo Cruz Foundation · Observational
In a previous study by the researchers' group, the researchers' investigate the duration of yellow fever post-vaccination immunity in vaccinated children between 9 and 23 months of age. However, in this study, samples of children in the pre-vaccine period, also known as unvaccinated children samples (NV) have not been investigated. It is believed that to seek evidence about the immune status in the medium and long term after vaccination against yellow fever is necessary to investigate paired samples of children not vaccinated (NV), with re-evaluation 30-45 days after primary vaccination. The proposed study is to consolidate aspects of humoral (neutralizing antibodies) and cellular (phenotypic and functional parameters of T cells and memory B) by means of complementary longitudinal investigation children, 9-23 months old, unvaccinated (NV) and 30-45 days after primary vaccination.
A sample of 60 children aged 9 to 23 months paired in the pre-vaccine period (NV) and 30-45 post-primary vaccination days will be selected at health facilities in the metropolitan region of Belo Horizonte.
Children whose mothers consent to participate in research, have collected blood and elements of past medical history recorded. Analyses of humoral and cellular biomarkers will be used in a comparative study with other post-vaccination periods previously analyzed in children during the first phase in study funded by the Ministry of Health.
specific objectives:
60 studies on the registry are indexed under Yellow Fever; 12 are open to participants now.
This study's enrollment of 60 is below the median of 278 across 12 observational studies indexed under Yellow Fever.
Browse Yellow Fever studies →Oswaldo Cruz Foundation is the lead sponsor of 42 studies on the registry; 7 are open to participants now.
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The study provides immunoassays paired before and after anti-yellow fever vaccination in children of both sexes, of any color, class or social group. This will be necessary 60 paired samples (pre-vaccine period and 30-45 days after primary vaccination) of children aged 9 to 23 months, living in areas where YF vaccine makes up the basic immunization calendar and will receive the vaccine in the routine of UBRs in the first two years of life. This study will be conducted with samples collected from children living in Ribeirão das Neves - Minas Gerais. It will be collected 7 mL of whole blood collected in Heparin Sodium. It will be allowed to make two attempts to collect only. These samples will be used for the realization of the humoral and cellular immunity study.
Will be eligible for the study:
Exclusion Criteria:
Quantification of Humoral and cellular immunity after first yellow fever vaccination
Consolidating aspects of humoral (quantification of neutralizing antibodies - \>2.log10IU/mL) and cellular (Percentege of phenotypic and functional parameters of T cells and B memory) through a complementary longitudinal investigation in children aged 9 to 23 month old unvaccinated and 30-45 days after first vaccination .
Time frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever
Quantification of titers of neutralizing antibodies in plasma samples
Quantify the titers of neutralizing antibodies against yellow fever immediately before and 30-45 days after primary vaccination against yellow fever in children 9-23 months of age without yellow fever vaccination history.
Time frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever
Evaluate the frequency (percentage) of T cells and B memory induced in vitro by the vaccine antigen 17DD
Evaluate the frequency (percentage) of T cells and B memory induced in vitro by the vaccine antigen 17DD immediately before and 30-45 days after primary vaccination against yellow fever in children 9-23 months old with no vaccination history against yellow fever.
Time frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever
Evaluate the frequency (percentage) of T and B cells expressing intracytoplasmic cytokines in vitro induced by the vaccine antigen 17DD
Evaluate the frequency (percentage) of T and B cells expressing intracytoplasmic cytokines (gama interferon; IL-5, alfa-TNF) CD8 + T lymphocytes, in vitro induced by the vaccine antigen 17DD immediately before and 30-45 days after primary vaccination against yellow fever, in children 9-23 months of age without yellow fever vaccination history.
Time frame: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Oswaldo Cruz Foundation