A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19

NCT04756830 | Unknown Phase 4 DMC

• 1 other identifier: IDOR_VAC_01
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label uncontrolled study in which all participants will receive two doses of the inactivated adsorbed vaccine against COVID-19, and will be followed up for safety and immunogenicity analysis for 24 months.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Frequency of local and systemic adverse reactions in the first 7 days after immunization

  Frequency of solicited and unsolicited local and systemic adverse reactions in the first 7 days after vaccination per age group (18-59 years old and 60 years old or older), attributed to the vaccine after causality assessment

  Seven days after each immunization

• Seroconversion rates

  Seroconversion rates in the second week after the second dose of the vaccine per age group (18-59 years and 60 years old or older).

  Two weeks after the second immunization

Secondary Outcomes (6)

• Frequency of adverse reactions up to 28 days after immunization

  28 days after the second immunization

• Frequency of severe adverse events

  Up to 12 months after first immunization

• Frequency of adverse events of special interest

  Up to 12 months after first immunization

• Cell-mediated immune response

  At inclusion and 4 weeks after the second vaccination

• Frequency of detection of antibodies against SARS-CoV-2

  At inclusion, and two weeks, 6 months, 12 months, 18 months and 24 months after the second vaccination

Other Outcomes (3)

• Frequency of confirmed cases of COVID-19

  Up to 24 months after inclusion

• Frequency of SARS-CoV-2 variants of concern (VOC)

  Up to 24 months after inclusion

• Humoral and cellular immune response

  Up to 24 months after inclusion

Study Arms (1)

Vaccination

OTHER

All participants will receive two doses of the inactivated adsorbed vaccine against COVID-19.

Biological: Adsorbed COVID-19 (inactivated) Vaccine

Interventions

Adsorbed COVID-19 (inactivated) Vaccine BIOLOGICAL

Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine

Also known as: CoronaVac

Vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older;
• Agree with study procedures after reading and signing the Informed Consent Form

You may not qualify if:

• Pregnancy (confirmed by positive β-hCG test), breastfeeding and / or expressing intention to have sexual practices with reproductive potential without using contraceptive methods in the three months following vaccination
• Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease, according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
• Diseases with impaired immune system including: neoplasms (except basal cell carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not controlled according to anamnesis or physical examination. Significant changes in treatment or hospitalizations due to worsening of the condition in the last three months are indicators of uncontrolled disease;
• Behavioral, cognitive or psychiatric illness that, in the opinion of the principal investigator or his medical representative, affects the participant's ability to understand and collaborate with the requirements of the study protocol
• History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
• History of asplenia;
• Previous participation in a COVID-19 vaccine evaluation study or previous exposure to a COVID-19 vaccine;
• Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be postponed until the participant completes 72 hours without symptoms or the diagnosis is ruled out);
• History of bleeding disorders (for example, deficiency of clotting factors, coagulopathy, platelet dysfunction), or previous history of bleeding or significant bruising after IM injection or venipuncture.
• Any other condition that, in the opinion of the principal investigator or his medical representative, could jeopardize the safety or rights of a potential participant or that would prevent him from complying with this protocol.

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• Butantan Institute: collaborator

Study Sites (2)

Hospital Gloria D'Or - Hospitais Integrados da Gavea S/A

Rio de Janeiro, 22211-230, Brazil

Location

D'Or Institute for Research and Education

Rio de Janeiro, 22281100, 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: February 19, 2021
• Primary Completion: September 1, 2021
• Study Completion: June 1, 2023
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)