UnknownNot Applicable

Complementary Study of the Duration of Post-vaccination Against Yellow Fever Immunity in Children

Brazil60 participantsStarted 2015-04

Plain-language summary

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.

Who can participate

Age range9 Months – 23 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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. Exclusion Criteria: * 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.

What they're measuring

Quantification of Humoral and cellular immunity after first yellow fever vaccination

Timeframe: Time 0 (immediately before) and Time 1 (30-45 days after) primary vaccination against yellow fever

Trial details

NCT IDNCT02990182

SponsorOswaldo Cruz Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04