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

NCT04789356 | Unknown Phase 4 DMC

• 1 other identifier: CAAE: 44076721.5.0000.0005
• Study Type: interventional
• Target: 6,233
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; Brazil; Covid-19; Vaccine; Sinovac; CoronaVac; Vaccine efficacy

Outcome Measures

Primary Outcomes (1)

• Incidence density of moderate and severe clinical cases of COVID-19

  Incidence density of moderate and severe clinical cases of COVID-19 (Grade 4 or higher according to the WHO clinical progression scale), after the second week after the second dose of the vaccine.

  2 weeks after the second vaccine dose

Secondary Outcomes (11)

• Incidence density of moderate and severe clinical cases of COVID-19 after first dose

  After first dose, up to 12 months.

• Incidence density of moderate and severe clinical cases of COVID-19 after second dose

  After second dose, up to 12 months.

• Incidence density of severe clinical cases of COVID-19 after second dose

  After second dose, up to 12 months.

• Median of clinical progression scores between moderate and severe cases

  After first dose, up to 12 months.

• Incidence density of clinical cases virologically confirmed as COVID-19

  After first dose, up to 12 months.

Study Arms (2)

High-risk individuals (with comorbidities)

ACTIVE COMPARATOR

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

Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine

Low-risk individuals (without comorbidities)

NO INTERVENTION

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.

Interventions

Adsorbed SARS-CoV-2 (inactivated) vaccine BIOLOGICAL

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

Also known as: CoronaVac

High-risk individuals (with comorbidities)

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);
• 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.

Sponsors & Collaborators

• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado: lead
• Butantan Institute: collaborator

Study Sites (1)

Escola Normal Superior - Universidade do Estado do Amazonas

Manaus, Amazonas, 69050-010, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Vaccines; sinovac COVID-19 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)

Biological Products; Complex Mixtures

Study Officials

• Marcus Lacerda, MD

  Fundação de Medicina Tropical Heitor Vieira Dourado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental study

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 9, 2021
• Study Start: March 18, 2021
• Primary Completion: July 5, 2021
• Study Completion: March 1, 2022
• Last Updated: July 26, 2021

Record last verified: 2021-07

Locations

BR (1)