Immunity, Yellow Fever Vaccine
Conditions
Keywords
Yellow Fever Vaccine, immunity evolution
Brief summary
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 description
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.
Interventions
BIOLOGICALyellow fever vaccine
yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
Sponsors
Ministry of Health, Brazil
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ability to understand and sign the Informed Consent Term 2. Acceptance in participate on the study after reading, understanding and signed the Informed Consent Term 3. Participants of both sexes aged 9-4 years, 11 months and 29 days, after it was provided they have not received or have to receive the MMR or Tetraviral vaccine within 30 days or less. 4. Healthy adults of both sexes aged between 18 and 50 years since they have not received or have to receive the MMR or Tetraviral vaccine within 30 days or less. 5. Residence fixed in the municipality where the Basic Health Unit will held vaccination and collection of biological material samples (blood) for the study at the time of participant enrollment. 6. Availability to follow the proposed activities throughout the study period. 7. Agreement to provide name, address, telephone number and other information for personal contact is possible, if necessary (for example, event of failure to visit scheduled for follow-up). 8. Availability to follow the study protocol. 9. Acceptance for serological testing for HIV. 10. In adult women, it will be conduct pregnancy test (TIG). 11. Being in good health with no significant medical history (such as those described in
Exclusion criteria
). 12. Physical examination of screening with no significant clinical changes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune response evolution in children and adults for yellow fever vaccine | before vaccination (day 0) | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interaction between dengue antibodies and the immune response evolution for yellow fever vaccine in children and adults. | before vaccination (day 0) | 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 | 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. |
| Immune response evolution in children and adults for yellow fever vaccine that did not respond to the first dose and were revaccinated. | Immediately before vaccination | seropositivity proportion and the yellow fever neutralizing antibodies geometric mean titers. |
Countries
Brazil
Outcome results
None listed