Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents (Curumim)

Efficacy, Immunogenicity and Safety of Inactivated Vaccine (Coronavac) Against SARS-COV2 in Children and Adolescents - Curumim Project

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Inactivated Coronavac/Butantan vaccine; Biological: BNT162b2 (Pfizer)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29041-295
      • Recruiting
      • Valéria Valim
      • Contact: Valeria Valim, PhD; Phone Number: +55 27 3315-7899; Email: val.valim@gmail.com
      • Contact: Carolina SE Gadelha, MSc; Phone Number: +55 27 99309-7010; Email: carolina.pneumoped@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VACC; This group will receive the inactivated Coronavac/Butantan vaccine.	Biological: Inactivated Coronavac/Butantan vaccine; Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart
Active Comparator: BNTC; This group will receive the immunizing BNT162b2 (Pfizer).	Biological: BNT162b2 (Pfizer); BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart
Active Comparator: ADU; This group of adults participants will receive the inactivated Coronavac/Butantan vaccine.	Biological: Inactivated Coronavac/Butantan vaccine; Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) will be carried out.	6 months

Collaborators and Investigators

• Sponsor: Federal University of Espirito Santo
• Collaborators: Butantan Institute; Centro de Pesquisas René Rachou; Secretaria de Estado da Saúde do Espírito Santo - SESA

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Anticipated): June 21, 2022
• Study Completion (Anticipated): March 21, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Children; Vaccine; covid-19; Coronavac; Vero Cell
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FUES04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No