Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2

Wang, Hui; Zhang, Yuntao; Huang, Baoying; Deng, Wei; Quan, Yaru; Wang, Wenling; Xu, Wenbo; Zhao, Yang; Li, Na; Zhang, Jin; Liang, Hongyang; Bao, Linlin; Xu, Yanfeng; Ding, Ling; Zhou, Weimin; Gao, Hong; Liu, Jiangning; Niu, Peihua; Zhao, Li; Wei, Zhen; Fu, Hua‐Hua; Yu, Shouzhi; Zhang, Zhengli; Xu, Guangxue; Li, Changgui; Lou, Zhiyong; Xu, Miao; Qin, Chuan; Wu, Guizhen; Gao, George F.; Tan, Wenjie; Yang, Xiaoming

doi:10.1016/j.cell.2020.06.008

Cited by 676 publications

(729 citation statements)

References 24 publications

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“…A safe and effective vaccine is the need of the hour to overcome the COVID-19 pandemic. In the global race for the development of vaccines, few research groups have reported the preclinical studies of viral vector vaccines (ChAdOx1 nCoV-19 and Ad-26.COV.2.S) 4,5 , mRNA vaccine (mRNA-1273) , DNA vaccine (INO-4800) 7 and inactivated vaccines (PiCoVacc and BBIBP-CorV) 8,9 . Phase I/II clinical trial are either completed or on-going for these vaccines.…”

Section: Discussionmentioning

confidence: 99%

Remarkable immunogenicity and protective efficacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques

Yadav¹,

Ella²,

Kumar³

et al. 2020

Preprint

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The COVID-19 pandemic is a global health crisis that has severely affected mankind and posed a great challenge to the public health system of affected countries. The availability of a safe and effective vaccine is the need of the hour to overcome this crisis. Here, we have developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in rhesus macaques (Macaca mulata). Twenty macaques were divided into four groups of five animals each. One group was administered a placebo while three groups were immunized with three different vaccine candidates at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 fourteen days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd-week post-immunization. Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which showed features of interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry. Data from this study substantiate the immunogenicity of the vaccine candidates and BBV152 is being evaluated in Phase I clinical trials in India (NCT04471519).

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Section: Discussionmentioning

confidence: 99%

Remarkable immunogenicity and protective efficacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques

Yadav¹,

Ella²,

Kumar³

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…Having said that, many of the SARS-CoV-2 vaccine candidates have undergone considerable pre-clinical testing, including challenge studies. There was no evidence of ADE in pre-clinical SARS-CoV-2 challenge studies in rhesus macaques following immunization with 1 dose of ChAdOx1 nCoV-19 ( 144 ) or 2 doses of the inactivated whole virus vaccine candidate BBIBP-CorV ( 97 ), both of which were protective in these studies. It is postulated that basing the vaccine on the S1 RBD terminal subunit of the S glycoprotein should overcome this problem by inducing nAbs only, although this has not been proven and, notably, only a few vaccine candidates have taken this approach.…”

Section: Potential Challenges In Sars-cov-2 Vaccine Developmentmentioning

confidence: 81%

“…The safety data ( Table 5 ) are discussed in section Comparative Safety and Tolerability Results for Current SARS-CoV-2 Vaccine Candidates in Clinical Trials. The Beijing inactivated vaccine candidate (BBIP-CorV) has published pre-clinical data confirming induction of high levels of nAbs in several animal models and protection against intra-tracheal SARS-CoV-2 challenge in rhesus macaques after 2 doses of vaccine ( 97 ). The Institute of Medical Biology/Chinese Academy of Medical Science has also developed an inactivated whole virus construct that is in a phase 1/2 trial; and Bharat Biotech International Ltd also has one in a phase 1/2 trial ( Table 2 ).…”

Section: Different Vaccine Approaches Used In Covid-19 Vaccine Develomentioning

confidence: 99%

Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines

et al. 2020

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There are currently around 200 SARS-CoV-2 candidate vaccines in preclinical and clinical trials throughout the world. The various candidates employ a range of vaccine strategies including some novel approaches. Currently, the goal is to prove that they are safe and immunogenic in humans (phase 1/2 studies) with several now advancing into phase 2 and 3 trials to demonstrate efficacy and gather comprehensive data on safety. It is highly likely that many vaccines will be shown to stimulate antibody and T cell responses in healthy individuals and have an acceptable safety profile, but the key will be to confirm that they protect against COVID-19. There is much hope that SARS-CoV-2 vaccines will be rolled out to the entire world to contain the pandemic and avert its most damaging impacts. However, in all likelihood this will initially require a targeted approach toward key vulnerable groups. Collaborative efforts are underway to ensure manufacturing can occur at the unprecedented scale and speed required to immunize billions of people. Ensuring deployment also occurs equitably across the globe will be critical. Careful evaluation and ongoing surveillance for safety will be required to address theoretical concerns regarding immune enhancement seen in previous contexts. Herein, we review the current knowledge about the immune response to this novel virus as it pertains to the design of effective and safe SARS-CoV-2 vaccines and the range of novel and established approaches to vaccine development being taken. We provide details of some of the frontrunner vaccines and discuss potential issues including adverse effects, scale-up and delivery.

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“…Until now, although the vaccine against COVID-19 is in full swing [24][25][26] , there are still no special and effective treatments 27,28 . Intensifying multidisciplinary treatments, such as enhanced nutritional support, anticoagulation (low molecular weight heparin [LMWH]), anti-in ammatory (γ-globulin, etc.…”

Section: Discussionmentioning

confidence: 99%

Predictive Risk Factors at Admission and a "Burning Point" During Hospitalization Serve as Sequential Alerts for Critical Illness in COVID-19 Patients

Zhou

Wang

et al. 2020

Preprint

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Background In critically ill COVID-19 patients, the crucial turning point before critical illness onset (CIO) remain largely unknown, and the combination of baseline risk factors with the turning point during hospitalization was rarely reported.Methods In this retrospective cohort study, 1150 consecutively admitted patients with confirmed COVID-19 were enrolled, including 296 critical and 854 non-critical patients. We compared the differences of all the clinically tested indicators and their dynamic changes between critical and non-critical patients. Three prediction models were established and validated based on the risk factors at admission, and an online baseline predictive tool was developed. Linear mixed model (LMM) was applied for longitudinal data analysis in 296 critical patients throughout the hospitalization, to predict the likelihood and possible time of critical illness in COVID-19 patients. A crucial turning point, where several indicators will experience a greater and significantly continuous change before CIO, was defined as “burning point” in our study. This point indicates the deterioration of patient’s condition before CIO.Results We established a novel two-checkpoint system to predict critical illness for COVID-19 patients in which the first checkpoint happened at patient admission was assessed by a baseline prediction model to project the likelihood of critical illness based on the variables selected from random forest and LASSO regression analysis, including age, SOFA score, neutrophil-to-lymphocyte ratio (NLR), D-dimer, lactate dehydrogenase (LDH), International Normalized Ratio (INR), and pneumonia area derived from CT images, which yields an AUC of 0.960 (95% confidence interval, 0.941-0.972) and 0.958 (0.936-0.980) in the training and testing sets, respectively. This model has been translated into a public web-based risk calculator. Furthermore, the second checkpoint (designated as “burning point” in our study) could be identified as early as 5 days preceding the CIO, and 12 (IQR, 7-17) days after illness onset. Seven most significant and representative “burning point” indicators were SOFA score, NLR, C-reactive protein (CRP), glucose, D-dimer, LDH, and blood urea nitrogen (BUN).Conclusions With this two-checkpoint prediction system, the deterioration of COVID-19 patients could be early identified and more intensive treatments could be started in advance to reduce the incidence of critical illness.

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Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2

Cited by 676 publications

References 24 publications

Remarkable immunogenicity and protective efficacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques

Remarkable immunogenicity and protective efficacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques

Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines

Predictive Risk Factors at Admission and a "Burning Point" During Hospitalization Serve as Sequential Alerts for Critical Illness in COVID-19 Patients

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