Yellow fever vaccine
Biologicalyellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
NCT Number: NCT02555072
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 study is active but is not currently recruiting participants.
Notify Me9 month–50 year
All sexes
Interventional
Phase 4
Unidade Saúde da Família Mata Redonda 1, Alhandra, Paraíba, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
Time frame: before vaccination (day 0)
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 30-45 days after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 1 year after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 4 years after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 7 years after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 10 years after vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: before vaccination (day 0)
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time frame: 30-45 days after vaccination
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time frame: 1 year after vaccination
Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
Time frame: immediately before vaccination ( day 0 )
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.
Time frame: 1 year after vaccination
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.
Time frame: 4 years after vaccination
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.
Time frame: 7 years after vaccination
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.
Time frame: 10 years after vaccination
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.
Time frame: Immediately before vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 30-45 days after revaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 1 year after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 4 years
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 7 years after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
Time frame: 10 years after first vaccination
seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Other
Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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