Effectiveness of the Adsorbed Vaccine COVID-19 (Coronavac) Among Education and Public Safety Workers With Risk Factors for Severity

NCT ID: NCT04789356

Last Updated: 2021-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 6233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2022-03-31

Brief Summary

This is a quasi-experimental study with risk-based allocation. Public security and education professionals from the state government will be included. In the initial evaluation, the presence of comorbidities associated with an increased risk of serious disease due to COVID-19 will be evaluated, according to the national plan for the implementation of vaccination against COVID-19. Those with at least one of these comorbidities will be invited to receive the study vaccine in two doses, with an interval of 28 days (±7 days). Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project. If, after 12 months, the participant in the low-risk group (no vaccine) has not received CoronaVac, or any other vaccine available, he/she will receive the vaccine, exactly as offered in the other group (two doses of CoronaVac with an interval of 28 days - with a tolerance of 7 days before or after). All participants will be followed up for 12 months from inclusion in the study. Immunization is expected to reduce the risk of moderate to severe disease of those with comorbidities to the level of those of the same age group who do not have these comorbidities but face similar occupational risks.

Conditions

Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-risk individuals (with comorbidities)

Public safety and security (police officers and law enforcement, fire department), and high school and college/university professionals of the state government public education network who present at least one of the comorbidities included in the National Plan for the Operationalization of Vaccination Against COVID-19 will be invited to receive the CoronaVac vaccine

Group Type: ACTIVE_COMPARATOR

Adsorbed SARS-CoV-2 (inactivated) vaccine

Intervention Type: BIOLOGICAL

600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Low-risk individuals (without comorbidities)

Participants with low risk (without comorbidities as a risk factor for severe COVID-19 according to the national plan for the implementation of vaccination against COVID-19) will not receive the vaccine within the scope of the research project.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adsorbed SARS-CoV-2 (inactivated) vaccine

600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.

Intervention Type: BIOLOGICAL

Other Intervention Names

CoronaVac

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 49 years
• Demonstrate availability to be accompanied during the follow-up time defined in the study, through visits, telephone contacts, or other means of digital communication.

Exclusion Criteria

• Prior vaccination for COVID-19;
• Diagnosis of COVID-19 in the last 28 days (nasal and oropharyngeal swab);
• History of severe allergic reaction or anaphylaxis to study vaccine components;
• Report of fever in the 72 hours prior to vaccination (the inclusion may be postponed until the participant completes 72 hours without fever);
• Possible or confirmed of COVID-19 on the day of vaccination (in this situation, vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
• Have received live attenuated virus vaccine in the last 28 days or inactivated vaccine in the last 14 days prior to inclusion in the study, or have immunization scheduled for the first 28 days after their inclusion in the study;
• Any other condition that, in the opinion of the principal investigator or his medical representative, could endanger the safety or rights of a potential participant or that would prevent him or her from complying with this protocol;
• Pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Butantan Institute

OTHER_GOV

Sponsor Role: collaborator

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Lacerda, MD

Role: PRINCIPAL_INVESTIGATOR

Fundação de Medicina Tropical Heitor Vieira Dourado

Locations

Escola Normal Superior - Universidade do Estado do Amazonas

Manaus, Amazonas, Brazil

Countries

Brazil

Other Identifiers

CAAE: 44076721.5.0000.0005

Identifier Type: -

Identifier Source: org_study_id