SARS-CoV-2 vaccines in advanced clinical trials: Where do we stand?

Chakraborty, Saborni; Mallajosyula, Vamsee; Tato, Cristina M.; Tan, Gene S.; Wang, Taia T.

doi:10.1016/j.addr.2021.01.014

Cited by 83 publications

(84 citation statements)

References 278 publications

(249 reference statements)

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“…The seroconversion rate of 97% for the anti-S1 IgG observed in HCWs is important data for the scientific community, since in phase III studies of this and other vaccine candidates for SARS-CoV-2, similar or lower seroconversion rates were observed 9 .…”

Section: Discussionmentioning

confidence: 95%

Dynamic of humoral response to SARS-CoV-2 anti Nucleocapsid and Spike proteins after CoronaVac vaccination

Bochnia-Bueno

SMd

et al. 2021

Preprint

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Background: This study aimed to calculate the seroconversion rate of the CoronaVac vaccine in healthcare workers (HCWs) 40 days after administration. Methods: Serum samples from 133 HCWs from Southern Brazil were collected one day before (Day 0) and 10, 20, and 40 days after administering the vaccines first dose. Immunoglobulin G (IgG) was quantified using immunoassays for anti-N-protein antibodies (Abbott, Sligo, Ireland) and for anti-S1 (spike) protein antibodies (Euroimmun, Lubeck, Germany). Results: Seroconversion by D 40 (20 days after the second dose) occurred in 129 (97%) HCWs for the S1 protein, and in 69 (51.87%) HCWs for the N protein. An absence of IgG antibodies (by both methodologies), occurred in two (1.5%) HCWs undergoing semiannual rituximab administration, and also in another two (1.5%) HCWs with no apparent reason. Conclusion: This study showed that CoronaVac has a high seroconversion rate when evaluated in an HCW population.

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Section: Discussionmentioning

confidence: 95%

Dynamic of humoral response to SARS-CoV-2 anti Nucleocapsid and Spike proteins after CoronaVac vaccination

Bochnia-Bueno

SMd

et al. 2021

Preprint

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“…A phase 3 study is currently underway in Abu Dhabi with 15,000 participants: 5000 participants receiving placebo, another 5000 receiving BBIBP-CorV, and the remaining 5000 receiving another inactivated vaccine manufacturer by Sinopharm [ 23 ].…”

Section: Bbibp-corvmentioning

confidence: 99%

COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials

2021

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Various strategies have been designed to contain the COVID-19 pandemic. Among them, vaccine development is high on the agenda in spite of the unknown duration of the protection time. Various vaccines have been under clinical trials with promising results in different countries. The protective efficacy and the short-term and long-term side effects of the vaccines are of major concern. Therefore, comparing the protective efficacy and risks of vaccination is essential for the global control of COVID-19 through herd immunity. This study reviews the most recent data of 12 vaccines to evaluate their efficacy, safety profile and usage in various populations.

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“…As of March 23, 2021, several vaccines have been approved for emergency use in multiple countries and are currently deployed for mass vaccinations globally (Zimmer et al 2021). The development and production of the COVID-19 vaccines relies on several technologies or platforms, mainly nucleic acid and viral vector vaccines as novel technologies and whole inactivated, live attenuated viral or recombinant protein subunit or virus-like particle vaccines as conventional platforms (Chakraborty et al 2021). Among the first to have received approval for use were two messenger RNA (mRNA)-based vaccines from Pfizer/BioNTech and Moderna, both produced in record time, but posing the challenges that are relatively expensive to manufacture and difficult to scale and require transportation and storage at ultra-low temperatures.…”

Section: Introductionmentioning

confidence: 99%

Process development and scale-up optimization of the SARS-CoV-2 receptor binding domain–based vaccine candidate, RBD219-N1C1

Lee

Liu

Chen

et al. 2021

Appl Microbiol Biotechnol

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A SARS-CoV-2 RBD219-N1C1 (RBD219-N1C1) recombinant protein antigen formulated on Alhydrogel® has recently been shown to elicit a robust neutralizing antibody response against SARS-CoV-2 pseudovirus in mice. The antigen has been produced under current good manufacturing practices (cGMPs) and is now in clinical testing. Here, we report on process development and scale-up optimization for upstream fermentation and downstream purification of the antigen. This includes production at the 1-L and 5-L scales in the yeast, Pichia pastoris, and the comparison of three different chromatographic purification methods. This culminated in the selection of a process to produce RBD219-N1C1 with a yield of >400 mg per liter of fermentation with >92% purity and >39% target product recovery after purification. In addition, we show the results from analytical studies, including SEC-HPLC, DLS, and an ACE2 receptor binding assay that were performed to characterize the purified proteins to select the best purification process. Finally, we propose an optimized upstream fermentation and downstream purification process that generates quality RBD219-N1C1 protein antigen and is fully scalable at a low cost. Key points • Yeast fermentation conditions for a recombinant COVID-19 vaccine were determined. • Three purification protocols for a COVID-19 vaccine antigen were compared. • Reproducibility of a scalable, low-cost process for a COVID-19 vaccine was shown. Graphical abstract

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SARS-CoV-2 vaccines in advanced clinical trials: Where do we stand?

Cited by 83 publications

References 278 publications

Dynamic of humoral response to SARS-CoV-2 anti Nucleocapsid and Spike proteins after CoronaVac vaccination

Dynamic of humoral response to SARS-CoV-2 anti Nucleocapsid and Spike proteins after CoronaVac vaccination

COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials

Process development and scale-up optimization of the SARS-CoV-2 receptor binding domain–based vaccine candidate, RBD219-N1C1

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