Covid-19
Conditions
Interventions
Sponsors
Instituto D'Or de Pesquisa e Ensino
Instituto D'Or de Pesquisa e Ensino
Eligibility
Inclusion criteria
Inclusion criteria: Male or female =18 years of age; Subjects are willing and able to comply with the study procedures; Individuals are willing and able to provide informed consent prior to screening; Subjects who received two doses of Sinovac/Butantan vaccine, 182 days (±30 days) prior to inclusion in this study; Female participants are eligible to participate in the study if they are not pregnant, have recently given birth or are breastfeeding
Exclusion criteria
Exclusion criteria: Subjects with fever >37.5 °C (axillary) or any acute illness at baseline (Day 1) or within 3 days prior to randomization; Individuals with a history of COVID-19; Subjects with a history of severe adverse reaction associated with a vaccine or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines as described in the latest summary of product characteristics for Sinovac/Butantan, Fiocruz/AstraZeneca, Pfizer/Wyeth, Janssen; Individuals with a known bleeding disorder that, in the investigator's opinion, would contraindicate intramuscular injection; Individuals with any severe or progressive neurological disorder, seizure disorder, or a history of Guillian-Barré syndrome; Subjects who received treatment with immunosuppressive therapy in the last 15 days, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study period; Individuals with autoimmune diseases, with the exception of: Hashimoto's thyroiditis, vitiligo, psoriasis, lupus discordes and the like, HIV positive individuals and/or being treated for HIV; Individuals who received any other investigational product within the 30 days prior to Day 1 or intend to participate in another clinical study at any time during the course of this study; Subjects who received any other licensed vaccine within 14 days of enrollment in this study or who plan to receive any vaccine within 28 days of vaccination; Subjects who received treatment with Rituximab or any other anti-CD20 monoclonal antibody within 9 months prior to Day 1 or planned during the study period; Administration of intravenous immunoglobulins and/or any blood products within 3 months of inclusion or planned administration during the study period; Individuals with any condition that, in the investigator's opinion, could interfere with the primary objectives of the study or represent additional risk to the participant; Any other Covid-19 vaccine with the exception of two doses of CoronaVac.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the humoral immune response to a homologous or heterologous (3rd dose) booster regimen in individuals previously vaccinated with two doses of Sinovac/Butantan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the neutralizing immune response of homologous or heterologous (3rd dose) booster regimen against wild-type strain according to the following groups (general; age stratification 18-60 vs. > 60 years).;Assess persistence of humoral immunity 6 months after primary vaccination with two doses of Sinovac/Butantan (general; age stratification 18-60 > 60 years).;Assess the neutralizing immune response against wild-type strain and against variants of concerns from homologous or heterologous 3rd booster regimens in individuals previously immunized with Sinovac/Butantan (2 doses).;Evaluate the reactogenicity and safety of the 3rd booster dose in a homologous and heterologous vaccination regimen in individuals previously immunized with two doses of Sinovac/Butantan.;Documentation of symptomatic infection confirmed by SARS-CoV-2 | — |
Countries
Brazil
Contacts
Public ContactIDOR -
Outcome results
None listed