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

Phase IV Study to Evaluate the Effectiveness of the Inactivated Adsorbed Vaccine Against COVID-19 CoronaVac, Among Public Safety and Education Workers With Risk Factors for Severity, in Manaus (Amazonas)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine

• Study Type: Interventional
• Enrollment (Actual): 6233
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Amazonas
    • Manaus, Amazonas, Brazil, 69050-010
      • Escola Normal Superior - Universidade do Estado do Amazonas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Biological: Adsorbed SARS-CoV-2 (inactivated) vaccine; 600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.; Other Names: CoronaVac
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence density of moderate and severe clinical cases of COVID-19 after first dose	Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the first dose	After first dose, up to 12 months.
Incidence density of moderate and severe clinical cases of COVID-19 after second dose	Incidence density of moderate and severe clinical cases of COVID-19 (grade 4 or higher according to the WHO clinical progression scale) from the second dose	After second dose, up to 12 months.
Incidence density of severe clinical cases of COVID-19 after second dose	Incidence density of severe clinical cases of COVID-19 (grade 6 or higher according to the WHO clinical progression scale) from the second dose	After second dose, up to 12 months.
Median of clinical progression scores between moderate and severe cases	Comparison of the median clinical progression scores according to the WHO clinical progression scale between groups	After first dose, up to 12 months.
Incidence density of clinical cases virologically confirmed as COVID-19		After first dose, up to 12 months.
Mortality confirmed as COVID-19	Incidence density of deaths confirmed as COVID-19	After first dose, up to 12 months.
Incidence density of hospitalizations for any cause		After first dose, up to 12 months.
Mortality from any cause	Density of mortality from any cause	After first dose, up to 12 months.
Adverse events	Frequency of adverse events associated with the need for medical care	Up to 7 days after each dose of the vaccine (Day 7 and Day 35)
Humoral and cell-mediated immune response	Quantification of humoral and cell-mediated immune response to vaccination in samples of a subgroup of participants	Before each vaccine dose and every 3 months, up to 12 months of follow-up.
Detection of antibodies against SARS-CoV-2 in samples		Before each vaccine dose and every 3 months, up to 12 months of follow-up

Collaborators and Investigators

• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Collaborators: Butantan Institute
• Investigators: Principal Investigator: Marcus Lacerda, MD, Fundação de Medicina Tropical Heitor Vieira Dourado

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2021
• Primary Completion (Actual): July 5, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Vaccine; Covid-19; Brazil; Vaccine efficacy; CoronaVac; Sinovac
• 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: CAAE: 44076721.5.0000.0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No