Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Federal University of Espirito Santo
- Enrollment
- 1120
- Locations
- 1
- Primary Endpoint
- B lymphocytes
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
Nine hundred sixty (960) participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC, N=640) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC, N=320). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU, N=160). The main outcome will be the geometric title of neutralizing antibodies and the secondary outcomes will be the incidence of the number of cases confirmed by RT-PCR, the cellular immune response and frequency of adverse events. Outcomes will be evaluated before the first dose, and 28 and 90 days after the second dose, and followup after 6 and 12 months. The study hypothesis is that the cellular and humoral immune response of children and adolescents is not inferior to the age group 18 to 49 years, who received Coronavac and compared to children vaccinated with the immunizing BNT162b2 (Pfizer) and that the inactivated vaccine presents lower reactogenicity for the age group studied.
Investigators
Valéria Valim
Prof Dr
Federal University of Espirito Santo
Eligibility Criteria
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).
Outcomes
Primary Outcomes
B lymphocytes
Time Frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
intracytoplasmic cytokines
Time Frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Viral neutralization assay
Time Frame: 3 months
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.
T lymphocytes
Time Frame: 12 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S)
Time Frame: 3 months
Results are expressed in AU/mL and data interpretation will be as follows: \<50 AU/mL = negative; ≥50 U/mL = positive.
Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2
Time Frame: 3 months
Results will be expressed as fluorescence intensity or pg/mL. The cutoff is 1.4 and \<1.4 = negative; ≥1.4 = positive.
Dosage of systemic soluble factors
Time Frame: 12 months
Chemokines, cytokines and growth factors - biomarkers of humoral and cellular response. Results will be expressed in pg/mL.
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro
Time Frame: 2 months
The results will be expressed as a positive percentage frequency for a given cell phenotype.
Secondary Outcomes
- RT-PCR confirmed cases(6 months)
- Adverse events(6 months)