Immunogenicity and safety of heterologous booster vaccination; with the covid-19 recombinant vaccine (AstraZeneca/Fiocruz), covid-19 mRNA vaccine (Pfizer/Wyeth) or covid-19 recombinant vaccine (Janssen), and homologous with inactivated covid-19 adsorbed vaccine (Sinovac/Butantan)
- Conditions
- Covid-19D012141
- Registration Number
- RBR-9nn3scw
- Lead Sponsor
- Instituto D'Or de Pesquisa e Ensino
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method