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| Name | Class |
|---|---|
| Centro de Pesquisas René Rachou | OTHER_GOV |
| Butantan Institute | OTHER_GOV |
| Secretaria de Estado da Saúde do EspÃrito Santo - SESA | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VACC | Experimental | This group will receive the inactivated Coronavac/Butantan vaccine. |
|
| BNTC | Active Comparator | This group will receive the immunizing BNT162b2 (Pfizer). |
|
| ADU | Active Comparator | This group of adults participants will receive the inactivated Coronavac/Butantan vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Coronavac/Butantan vaccine | Biological | Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| T lymphocytes | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 12 months |
| B lymphocytes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valéria Valim | Recruiting | Vitória | EspÃrito Santo | 29041-295 | Brazil |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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Participants will be randomized into 2 groups, in a 2:1 ratio, to receive the inactivated Coronavac/Butantan vaccine (VACC) and a group to receive the immunizing BNT162b2 (Pfizer) (BNTC). The VACC group will also be compared to a group of adults aged 18 to 49 who received Coronavac (ADU).
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For blinding, the vaccine dose will be prepared by a pharmacist, who will be the only one who will know which immunizer will be administered. Vaccinators, participants and evaluators will not know which immunizer will be given.
| BNT162b2 (Pfizer) | Biological | BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart |
|
The results will be expressed as a positive percentage frequency for a given cell phenotype. |
| 12 months |
| intracytoplasmic cytokines | The results will be expressed as a positive percentage frequency for a given cell phenotype. | 12 months |
Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) will be carried out.
| 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |