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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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The study main objective is to assess the immune status of children and adults who have never vaccinated, they will receive the first dose of 17DD yellow fever vaccine provided by the study and will be monitored for 10 years. Depending on the results of the analyzed of the data, the period of monitoring may be extended.
This is a Phase IV study cohort, uncontrolled, composed of two segments: children and healthy adults. It will be included 2756 children and 2005 adults, evaluated initially in six different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years after vaccination). The Paraiba state was selected for the study because in this region there are no yellow fever virus dissemination and therefore no NIP recommendation for people's routine vaccination. However, the NIP indicate yellow fever vaccination for individuals who are moving to areas with virus circulation. The study will take place in six (6) Basic Health Units of three (3) municipalities (2 units per municipality) in the state of Paraíba. The selected municipalities are: Alhandra, Caaporã and Conde. The study target population consisted of healthy children and adults of both sexes. Children must be between 9 months and 4 years,11months and 29 days; adults between 18 and 50 years. It will be eligible for the study, people who have never received the yellow fever vaccine checked in vaccine design and history and who agree to participate. Not be included participants with any contraindication to vaccination against yellow fever and individuals who previously moved to risk areas for extended periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naive children and adults for yellow fever vaccine | Other | both sexes; ages between 9 months and 4 years, 11 months and 29 days old; 18 years to 50 years old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yellow fever vaccine | Biological | yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | before vaccination (day 0) |
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 30-45 days after vaccination |
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 1 year after vaccination |
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 4 years after vaccination |
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 7 years after vaccination |
| Immune response evolution in children and adults for yellow fever vaccine | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 10 years after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. | Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine. | before vaccination (day 0) |
| Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Sergio S Sousa, MD | Universidade Federal da Paraíba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Saúde da Família Oiteiro I | Alhandra | Paraíba | 58320000 | Brazil | ||
| Unidade Saúde da Família Mata Redonda 1 |
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Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine. |
| 30-45 days after vaccination |
| Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. | Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine. | 1 year after vaccination |
| Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults | Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection. | immediately before vaccination ( day 0 ) |
| Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults | Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection. | 1 year after vaccination |
| Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults | Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection. | 4 years after vaccination |
| Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults | Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection. | 7 years after vaccination |
| Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults | Number of vaccine doses, age of the participant per years, age at vaccination, gender, personal vaccination record, vaccination history against yellow fever in infants' mothers, history of severe diseases (hospitalization, sequels, disability ), comorbidities and medications used at the time of blood collection. | 10 years after vaccination |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | Immediately before vaccination |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 30-45 days after revaccination |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 1 year after first vaccination |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 4 years |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 7 years after first vaccination |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. | 10 years after first vaccination |
| Alhandra |
| Paraíba |
| 58320000 |
| Brazil |
| Unidade de Saúde da Família Cupissura I | Caaporã | Paraíba | 58326000 | Brazil |
| Unidade de Saúde da Família Santo Antônio | Caaporã | Paraíba | 58326000 | Brazil |
| Unidade de Saúde da Família N Sra da Conceição | Conde | Paraíba | 58322000 | Brazil |
| Unidade de Saúde da Família N Sra das Neves | Conde | Paraíba | 58322000 | Brazil |
| ID | Term |
|---|---|
| D022341 | Yellow Fever Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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