Clinical Trial: Immunity Period After One Dose of Yellow Fever Vaccine in Adults and Children (Paraiba Study)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area

Brief Summary: 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: Alhambra, 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. 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.

Detailed Summary:
Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Current Primary Outcome:

• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: before vaccination (day 0) ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: 30-45 days after vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: 1 year after vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: 4 years after vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: 7 years after vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine [ Time Frame: 10 years after vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. [ Time Frame: before vaccination (day 0) ]
  Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. [ Time Frame: 30-45 days after vaccination ]
  Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
• Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. [ Time Frame: 1 year after vaccination ]
  Anti-dengue virus IgG antibodies and neutralizing antibodies to yellow fever vaccine.
• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults [ 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.
• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults [ 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.
• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults [ 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.
• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults [ 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.
• Association between sociodemographic factors, personal medical history and immune status to yellow fever in children and adults [ 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.
• Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. [ Time Frame: Immediately before vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. [ Time Frame: 30-45 days after revaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. [ Time Frame: 1 year after first vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. [ Time Frame: 4 years ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
• Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. [ Time Frame: 7 years after first vaccination ]
  seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers.
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  Original Secondary Outcome: Same as current
  
  Information By: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
  

  Dates:
  Date Received: April 22, 2015
  Date Started: July 2016
  Date Completion: December 2027
  Last Updated: July 7, 2016
  Last Verified: July 2016