Immunogenicity, Effectiveness, and Safety of Inactivated Virus (CoronaVac) Vaccine in a Two-Dose Primary Protocol and BNT162b2 Heterologous Booster in Brazil (Immunita-001): A One Year Period Follow Up Phase 4 Study

Grenfell, Rafaella Fortini Queiroz; Almeida, Nathalie BF; Filgueiras, Priscilla Soares; Corsini, Camila Amormino; Gomes, Sarah  VC; Miranda, Daniel  AP de; Lourenço, Adelina  J.; Filho, Olindo Assis Martins; Oliveira, Jaquelline Germano de; Teixeira-Carvalho, Andréa; Campos, Guilherme R. F.; Nogueira, Maurício Lacerda; Alves, Pedro Augusto; Fernandes, Gabriel R.; Castilho, Leda R.; Lima, Túlio M.; Abreu, Daniel PB de; Alvim, Renata G. F.; Silva, Thais Barbara de S.; Jeremias, Wander  de J.; Otta, Dayane Andriotti; Campi-Azevedo, Ana Caroline

doi:10.2139/ssrn.4070408

Cited by 4 publications

(10 citation statements)

References 10 publications

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“…Data reported in this study confirms previous findings that natural infections act as additional booster to raise the levels of IgG reactive to Spike (Grenfell et al . 2022).…”

Section: Discussionsupporting

confidence: 93%

“…Furthermore, the presence of preexisting Spike binding antibodies in the population (Fig. S1B), despite the low neutralizing activity against omicron (Grenfell et al . 2022), are likely to be a key factor to reduce case fatality by reducing viral replication through Fc-mediated processes (Sadarangani, Marchant and Kollmann 2021).…”

Section: Discussionmentioning

confidence: 93%

“…Other studies in Brazil identified that both vaccine efficacy and anti-Spike IgG levels decreased >180 days after primary vaccination with CoronaVac (Cerqueira-Silva et al . 2022; Grenfell et al . 2022).…”

Section: Discussionmentioning

confidence: 99%

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Populational analysis of the immunoglobulin G response to different COVID-19 vaccines in Brazil

Paula

Conzentino

Gonçalves

et al. 2022

Preprint

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Vaccination is a strategy that confers protection against symptomatic infections and/or development of severe COVID-19. In Brazil, COVID-19 vaccination began in January 2021 and has been performed using vaccines from different manufactures including CoronaVac (Sinovac), ChAdOx1 (Oxford/AstraZeneca) and BNT162b2 (Pfizer/BioNTech). One of the main protective mechanisms triggered by vaccination involves the production of IgG antibodies reactive to the Spike antigen of SARS-CoV-2, the levels of which correlates with vaccine efficacy. Although phase III clinical studies confirmed the efficacy of the vaccines used in Brazil, there are just few studies comparing vaccine immunogenicity in a real-world scenario. This study aimed to depict the IgG response to natural infections and to vaccination using different types of vaccines at population scale in Matinhos, a city located in south of Brazil. Nucleocapsid seroconversion rates indicated that more than a quarter of the cohort has been subjected to natural infections by SARS-CoV-2 by the first trimester of 2022. Spike seroconversion rates achieved >95% by February 2022 and maintained stable as far as June 2022 confirming the effectiveness of the vaccination program. Immunogenicity concerning IgG reactive to Spike was higher using the BNT162b2 vaccine, followed by ChAdOx1 and CoronaVac. Natural infections boosted IgG levels reactive to Spike in those individuals that completed primary vaccination with ChAdOx1 and CoronaVac but not with BNT162b2. The levels of IgG reactive to Spike increased with the number of vaccine doses administered. The application of BNT162b2 as booster dose resulted in high levels of IgG reactive to Spike which were similar despite the type of the vaccine used during primary vaccination.

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“…Data reported in this study confirms previous findings that natural infections act as additional booster to raise the levels of IgG reactive to Spike (Grenfell et al . 2022).…”

Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 93%

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Populational analysis of the immunoglobulin G response to different COVID-19 vaccines in Brazil

Paula

Conzentino

Gonçalves

et al. 2022

Preprint

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“…To evaluate the presence of neutralizing antibodies induced by vaccination, the selected participants were submitted to a vaccination scheme consisting of the inoculation with two 0.5 ml shots of CoronaVac (600 SU per dose) in the original protocol, receiving a 0.3 ml booster of BNT162b2 (30 µg of spike mRNA per dose). This is a part of a major study evaluating the CoronaVac vaccination protocol that it is published as a preprint at SSRN 10 . A total of 90 individuals, randomly selected, were included in the study.…”

Section: Methodsmentioning

confidence: 99%

“…The neutralization capacity was determined by the presence or absence of cytopathic effect across the dilutions, and for each sample, it was obtained the reciprocal dilution value where 50% of cytopathic effect was avoided (VNT 50 ). All samples, at all dilutions, were tested in triplicate and VNT 50 was calculated by the use of the Spearman-Karber algorithm 10,11 . To validate the assay, a serum sample already known to neutralize Omicron and a sample collected before the pandemics were used as positive and negative control, respectively.…”

Section: Methodsmentioning

confidence: 99%

Booster dose of BNT162b2 after two doses of CoronaVac improves neutralization of SARS-CoV-2 Omicron variant

et al. 2022

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Background The emergence of the new SARS-CoV-2 Omicron variant, which is known to have a large number of mutations when compared to other variants, brought to light the concern about vaccine escape, especially from the neutralization by antibodies induced by vaccination. Methods Based on viral microneutralization assays, we evaluated in 90 individuals the impact on antibody neutralization induction, against Omicron variant, by a booster dose of BNT162b2 mRNA vaccine after the CoronaVac primary vaccination scheme. Results Here we show that the percentage of seroconverted individuals 30 and 60 days after CoronaVac scheme was 16.6% and 10%, respectively. After booster dose administration, the seroconvertion rate increased to 76.6%. The neutralization mean titer against Omicron in the CoronaVac protocol decreased over time, but after the booster dose, the mean titer increased 43.1 times. Conclusions These results indicate a positive impact of this vaccine combination in the serological immune response against SARS-CoV-2 Omicron variant.

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Evidence synthesis and pooled analysis of vaccine effectiveness for COVID-19 mRNA vaccine BNT162b2 as a heterologous booster after inactivated SARS-CoV-2 virus vaccines

Kyaw

Spinardi²,

Zhang

et al. 2023

Human Vaccines & Immunotherapeutics

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Introduction of primary COVID-19 vaccination has helped reduce severe disease and death caused by SARS-CoV-2 infection. Understanding the protection conferred by heterologous booster regimens informs alternative vaccination strategies that enable programmatic resilience and can catalyze vaccine confidence and coverage. Inactivated SARS-CoV-2 vaccines are among the most widely used vaccines worldwide. This review synthesizes the available evidence identified as of May 26, 2022, on the safety, immunogenicity, and effectiveness of a heterologous BNT162b2 (Pfizer-BioNTech) mRNA vaccine booster dose after an inactivated SARS-CoV-2 vaccine primary series, to help protect against COVID-19. Evidence showed that the heterologous BNT16b2 mRNA vaccine booster enhances immunogenicity and improves vaccine effectiveness against COVID-19, and no new safety concerns were identified with heterologous inactivated primary series with mRNA booster combinations.

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Immunogenicity, Effectiveness, and Safety of Inactivated Virus (CoronaVac) Vaccine in a Two-Dose Primary Protocol and BNT162b2 Heterologous Booster in Brazil (Immunita-001): A One Year Period Follow Up Phase 4 Study

Cited by 4 publications

References 10 publications

Populational analysis of the immunoglobulin G response to different COVID-19 vaccines in Brazil

Populational analysis of the immunoglobulin G response to different COVID-19 vaccines in Brazil

Booster dose of BNT162b2 after two doses of CoronaVac improves neutralization of SARS-CoV-2 Omicron variant

Evidence synthesis and pooled analysis of vaccine effectiveness for COVID-19 mRNA vaccine BNT162b2 as a heterologous booster after inactivated SARS-CoV-2 virus vaccines

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