An Observer-blind, Cohort Randomized, Exploratory Phase 3 Study to Evaluate the Safety and Immunogenicity of Recombinant Covid-19 Vaccine (AstraZeneca/Fiocruz), mRNA Covid-19 (Comirnaty, Pfizer/Wyeth) Vaccine and Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019-Clover) as 4th Dose in Individuals Primed/ Boosted With Various Regimens

This is an exploratory phase 3, cohort randomized, observer-blind, multi-center study to evaluate the safety and immunogenicity of a 4th dose of various SARS-CoV-2 vaccines. There will be 04 study cohorts, that have previously received 03 doses of the indicated vaccine (s), divided into 10 groups; and each one of the 10 study groups will receive the 4th dose. This exploratory study will enroll up to 360 participants in 4 cohorts and a total of 10 groups: Cohort A (N=90), Cohort B (N= 90), Cohort C (N=150) and Cohort D (N=30). In cohorts A-C participants will be randomized 1:1:1 to three different 4th dose regimens. The number of proposed participants will provide a reasonable accurate descriptive summary of the safety and immunogenicity of the tested vaccination regimens.

开始日期2022-08-01

申办/合作机构

D'Or Institute for Research & Education

[+2]

RBR-9nn3scw / Not yet recruiting临床4期IIT

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

开始日期2021-08-01

申办/合作机构-

100 项与 COVID-19 mRNA vaccine (Fiocruz) 相关的临床结果

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100 项与 COVID-19 mRNA vaccine (Fiocruz) 相关的转化医学

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100 项与 COVID-19 mRNA vaccine (Fiocruz) 相关的专利（医药）

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项与 COVID-19 mRNA vaccine (Fiocruz) 相关的文献（医药）

2022-11-01·Vaccine

Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil

Article

作者: Crowe, Madeleine ; Spadaro, André Gasparini ; Tasca, Karen Ingrid ; Verstraeten, Tom ; Clemens, Sue Ann Costa ; Martins, Marcelo Roberto ; Barretti, Pasqual ; Grotto, Rejane Maria Tommasini ; Clemens, Ralf ; Pollard, Andrew ; Fortaleza, Carlos Magno Castelo Branco

INTRODUCTION:

Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18-60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign.

METHODS:

The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines.

RESULTS AND DISCUSSION:

A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell's palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events.

100 项与 COVID-19 mRNA vaccine (Fiocruz) 相关的药物交易

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