Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quantification of Humoral and cellular immunity after first yellow fever vaccination
研究概览
简要总结
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.
详细描述
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:
- Estimate and compare the proportion of positivity and the geometric mean plasma titers of neutralizing antibodies against yellow fever;
- Assess lymphocyte frequency T and B memory induced in vitro by the vaccine antigen 17DD substrains, and...
- Quantify the lymphocytes T CD8 + producers of intracytoplasmic cytokines induced in vitro by the vaccine antigen 17DD substrains in unvaccinated children and primed aged between 9 and 23 months, categorized according to the vaccination time 30-45 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Will be eligible for the study:
- •children 9-23 months of age;
- •both sexes;
- •children who will be vaccinated against yellow fever, whose parents or guardians sign the consent form.
排除标准
- •children who received another vaccine within 30 days before or after the yellow fever vaccine;
- •children which have permanent or temporary immunosuppression, including those treated with corticosteroids at doses higher than 2 mg / kg, and those with disease autoimmune diseases, transient or permanent immunosuppression induced diseases (cancer, AIDS, etc.) or treatment (immunosuppressive drugs, radiotherapy, etc.). Corticosteroids (such as prednisone, dexamethasone) for less than two weeks, or by inhalation or topical use, do not indicate exclusion from the study, but must be registered in the questionnaire (Annex II);
- •children with hemoglobinopathies;
- •children with a history of blood transfusion or treatment with hyperimmune serum up to 90 days prior to blood collection.
结局指标
主要结局
Quantification of Humoral and cellular immunity after first yellow fever vaccination
时间窗: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever
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 .
次要结局
- Evaluate the frequency (percentage) of T cells and B memory induced in vitro by the vaccine antigen 17DD(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(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(Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever)
研究者
Olindo de Assis Martins Filho
PhD
Oswaldo Cruz Foundation