Evaluation of zika test for yellow fever vaccineted.
- Conditions
- Zika Virus InfectionDengueYellow FeverArbovirus InfectionsC02.081.990C02.081.270C02.081.980C02.081
- Registration Number
- RBR-5g4n3p
- Lead Sponsor
- Instituto de Tecnologia em Imunobiológicos de BioManguinhos/Fundação Oswaldo Cruz (Fiocruz)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Adult participant or the person legally responsible be able to understanding and signing the TCLE. If the participant or the person legally responsible in charge is not able to sign, the TCLE can be signed by an impartial witness who has been following the whole procedure; Acceptance of participation in the study, after reading and understanding of the Informed Consent Form (TCLE) and signature of the same; Participants of both genders aged from 9 months to 4 years 11 months and 29 days, since they are not received or received by Viral Triple Vaccine or Viral Tetra within an interval of 30 days or less; Healthy adults of both genders aged 18-50 years since they are not received or received by MMR or MMR within 30 days or less; Permanent residence in the municipality where a Basic Health Unit is located, where a vaccination and collection of biological material (blood) is carried out for the study, at the time of inclusion in the study; Never have resided or stayed temporarily in an area with a yellow fever vaccination recommendation; Do not travel to areas with vaccination recommendation against yellow fever; Availability for follow-up activities throughout the study period; Agree on provide the name, address, telephone and other personal information, if applicable, if necessary (for example, in the case of a missed visit scheduled for follow-up); Availability to follow the study protocol; Acceptance for serological testing for HIV; In adult women of childbearing age, a pregnancy test (TIG); Have a good health with no significant medical history (as described in the exclusion criteria); Physical examination of significant clinical clinical trials.
Previous vaccination for yellow fever; Presumed or confirmed pregnancy, at any stage; Women who are breastfeeding; People in current or recent use of immunosuppressive drugs; People with a personal history of anaphylactic reaction to food, medicine, or vaccines; People with a personal history of egg, erythromycin, kanamycin, or gelatin allergies; People with autoimmune diseases; HIV-seropositive individuals; People with a history of thymus diseases, such as thymoma, myasthenia gravis and thymectomy due to thymoma; Persons who have received immunoglobulin, blood transfusions or derivatives in the last 60 days; Persons who have received live virus or cholera vaccines within the past 30 days or who plan to receive them within 30 days after vaccination for yellow fever; People with acute febrile illness, with compromised general health; Persons who have presented rash within the past 30 days; Persons immunocompromised by disease (eg neoplasms, AIDS, HIV infection with impaired immunity etc.) or by drugs (immunosuppressive drugs, radiation therapy etc.).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Influence of antibodies against dengue and yellow fever on the performance of TR DPP IgM / IgG Zika;<br>The results will be analyzed through neutralizing antibody titration analysis (PRNT), which is considered the most sensitive and specific test for yellow fever; and Serology for dengue and Zika.<br><br>
- Secondary Outcome Measures
Name Time Method Prevalence of seropositivity to arboviruses at baseline and their incidence at the end of the follow-up period;<br>The prevalence of seropositivity for dengue and zika in the population at the time of inclusion in the study will be calculated initially, and their respective incidence at the end of the study. Parametric and non-parametric statistical tests will be used to compare the socio-demographic characteristics of the positive and negative groups for each of the arboviruses and for the positive ones among the arboviruse
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