Clinical trial NCT05225285: Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents
Official title: Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: covid-19
Vaccine
Children
Coronavac
Vero Cell
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
Collaborators: name: Centro de Pesquisas René Rachou
name: Butantan Institute
name: Secretaria de Estado da Saúde do Espírito Santo - SESA
First posted: 2022-02-04
Enrollment: 1120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Viral neutralization assay
timeFrame: 3 months
measure: Chemiluminescence serological assay for qualitative and quantitative determination of neutralizing antibodies against Spike protein (anti-SARS-Cov-2 anti-IgG-S)
timeFrame: 3 months
measure: Serological assay by chemiluminescence for qualitative and quantitative determination of specific IgG antibodies against the nucleocapsid protein of SARS-Cov-2
timeFrame: 3 months
measure: Dosage of systemic soluble factors
timeFrame: 12 months
measure: Antigen-specific stimulation of peripheral blood mononuclear cells in vitro
timeFrame: 2 months
measure: T lymphocytes
timeFrame: 12 months
measure: B lymphocytes
timeFrame: 12 months
measure: intracytoplasmic cytokines
timeFrame: 12 months
Secondary outcomes:
measure: RT-PCR confirmed cases
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: Valéria Valim
state: Espírito Santo
Study officials:
References: