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

NCT05225285 | Unknown Phase 3 DMC

• 1 other identifier: FUES04
• Study Type: interventional
• Target: 1,120
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

covid-19; Vaccine; Children; Coronavac; Vero Cell

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• RT-PCR confirmed cases

  6 months

• Adverse events

  6 months

Study Arms (3)

VACC

EXPERIMENTAL

This group will receive the inactivated Coronavac/Butantan vaccine.

Biological: Inactivated Coronavac/Butantan vaccine

BNTC

ACTIVE COMPARATOR

This group will receive the immunizing BNT162b2 (Pfizer).

Biological: BNT162b2 (Pfizer)

ADU

ACTIVE COMPARATOR

This group of adults participants will receive the inactivated Coronavac/Butantan vaccine.

Biological: Inactivated Coronavac/Butantan vaccine

Interventions

Inactivated Coronavac/Butantan vaccine BIOLOGICAL

Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart

ADU; VACC

BNT162b2 (Pfizer) BIOLOGICAL

BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart

BNTC

Eligibility Criteria

• Age: 3 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 3 and 17 years old (VACC and BNTC groups)
• Age between 18 and 49 years old (ADU group)

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Valéria Valim

Vitória, Espírito Santo, 29041-295, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Model Details: 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).

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 4, 2022
• Study Start: January 21, 2022
• Primary Completion: June 21, 2022
• Study Completion: March 21, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)