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

COVID-19 Clinical Trial

— Curumim  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225285
• Other study ID #: FUES04
• Status: Recruiting
• Phase: Phase 3
• Start date: January 21, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: February 2022
• Source: Federal University of Espirito Santo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: March 21, 2023
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 49 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Inactivated Coronavac/Butantan vaccine
Inactivated Coronavac/Butantan vaccine in 2 doses of 0.5 ml, 4 weeks apart
• BNT162b2 (Pfizer)
BNT162b2 (Pfizer) vaccine in 2 doses of 0.1 ml or 0.30 ml (according to age group), 4 weeks apart

Locations

Country	Name	City	State
Brazil	Valéria Valim	Vitória	Espírito Santo

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Espirito Santo	Butantan Institute, Instituto René Rachou/Fiocruz, Secretaria de Estado da Saúde do Espírito Santo - SESA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	T lymphocytes	The results will be expressed as a positive percentage frequency for a given cell phenotype.	12 months
Primary	B lymphocytes	The results will be expressed as a positive percentage frequency for a given cell phenotype.	12 months
Primary	intracytoplasmic cytokines	The results will be expressed as a positive percentage frequency for a given cell phenotype.	12 months
Secondary	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
Secondary	Adverse events	Surveillance of adverse post-vaccine events (PVAE) and adverse events of special interest (EAIE) will be carried out.	6 months