Phase 4, randomized, controlled, single-blind study to assess the immunogenicity and safety of a third dose of heterologous booster with recombinant covid-19 vaccine (AstraZeneca/Fiocruz), covid-19 mRNA vaccine (Pfizer/Wyeth) or vaccine recombinant covid-19 (Janssen) in subjects previously vaccinated against Covid-19 with two doses of Sinovac/Butantan compared to a third homologous booster dose of adsorbed inactivated covid-19 vaccine (Sinovac/Butantan) in adults

Instituto D'Or de Pesquisa e Ensino0 sitesJuly 30, 2021

ConditionsCovid-19 D012141

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Covid-19
Sponsor: Instituto D'Or de Pesquisa e Ensino
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2021

End Date

October 31, 2021

Last Updated

2 years ago

Study Type

Intervention

Investigators

Sponsor

Instituto D'Or de Pesquisa e Ensino

Eligibility 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

•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.