COVID-19 Clinical Trial
— CurumimOfficial title:
Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
Verified date | February 2022 |
Source | Federal University of Espirito Santo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy and safety of vaccinating children and adolescents, aged 3 to 17 years, with a two-dose schedule of the inactivated vaccine (Coronavac) against SARS-Cov-2.
Status | Recruiting |
Enrollment | 1120 |
Est. completion date | March 21, 2023 |
Est. primary completion date | June 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 49 Years |
Eligibility | Inclusion Criteria: - Age between 3 and 17 years old (VACC and BNTC groups) - Age between 18 and 49 years old (ADU group) Exclusion Criteria: - Pregnant teenagers; - History of severe allergic reaction (anaphylaxis, urticaria or angioedema) to any previously administered vaccine; - Have previously received a vaccine against COVID-19; - Personal history of SARS-CoV-2-related Multisystem Inflammatory Syndrome (MIS-C); - Immunosuppressed due to conditions such as inborn error of metabolism, HIV infection, neoplasia or use of immunosuppressive drugs (systemic corticosteroids for more than 14 days or another immunosuppressant). |
Country | Name | City | State |
---|---|---|---|
Brazil | Valéria Valim | Vitória | Espírito Santo |
Lead Sponsor | Collaborator |
---|---|
Federal University of Espirito Santo | Butantan Institute, Instituto René Rachou/Fiocruz, Secretaria de Estado da Saúde do Espírito Santo - SESA |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral neutralization assay | Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title > 1:50 will be considered positive. | 3 months | |
Primary | Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S) | Results are expressed in AU/mL and data interpretation will be as follows: <50 AU/mL = negative; =50 U/mL = positive. | 3 months | |
Primary | Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2 | Results will be expressed as fluorescence intensity or pg/mL. The cutoff is 1.4 and <1.4 = negative; =1.4 = positive. | 3 months | |
Primary | Dosage of systemic soluble factors | Chemokines, cytokines and growth factors - biomarkers of humoral and cellular response. Results will be expressed in pg/mL. | 12 months | |
Primary | Antigen-specific stimulation of peripheral blood mononuclear cells in vitro | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 2 months | |
Primary | T lymphocytes | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 12 months | |
Primary | B lymphocytes | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 12 months | |
Primary | intracytoplasmic cytokines | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 12 months | |
Secondary | RT-PCR confirmed cases | Cases confirmed by RT-PCR, whose signs/symptoms have started 15 days after the second dose of vaccine, over 6 months after receiving the vaccine. | 6 months | |
Secondary | Adverse events | Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) will be carried out. | 6 months |
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