Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Kaabi, Nawal Al; Yang, Yun Kai; Du, Li Fang; Xu, Ke; Shao, Shuai; Liang, Yu; Kang, Yubin; Su, Ji Guo; Zhang, Jing; Yang, Tian; Hussein, Salah; ElDein, Mohamed Saif; Yang, Sen; Lei, Wenwen; Gao, Xue; Jiang, Zhiwei; Cong, Xiangfeng; Tan, Yao; Wang, Hui; Li, Meng; Mekki, Hanadi Mekki; Zaher, Walid; Mahmoud, Sally; Zhang, Xue; Qu, Chang; Liu, Dan Ying; Yang, Mengjie; Eltantawy, Islam; Hou, Jun; Lei, Ze Hua; Xiao, Peng; Wang, Zhao Nian; Yin, Jin Liang; Mao, Xiao Yan; Zhang, Jin; Qu, Liang; Zhang, Yun Tao; Yang, Xiaoming; Wu, Guizhen; Li, Qi Ming

doi:10.1038/s41467-022-31379-0

Cited by 32 publications

(19 citation statements)

References 23 publications

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“…The overall safety and reactogenicity profile of one SCTV01C boost was similar to that of reported homologous prime/booster with inactivated vaccines (CoronaVac showed 6–18% solicited ARs and 1–16% of injection-site pain. BBIBP-CorV showed 12.72% solicited ARs, 3.98% of injection-site pain and 4.2% of headaches), 11 , 21 and comparable to the AEs of the primary 2 dose series of inactivated vaccines. 22 , 23 Contrastingly, greater reactogenicity, such as fatigue, headache, arthralgia, myalgia, nausea, diarrhea, fever, chill, irritability, loss of appetite and pain at the injection-site were commonly observed in homologous/heterologous boosting with adenoviral vectored vaccines or mRNA vaccines.…”

Section: Discussionmentioning

confidence: 71%

“…The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) has recommended updating the composition of current COVID-19 vaccines when developing multivalent or broad-protective vaccines against SARS-CoV-2 current and future emerging variants. 9 Trials based on broad-spectrum anti-coronavirus vaccines using multivalent design, including mRNA-1273.211 (bivalent wild type and Beta variants, Moderna), 10 mRNA-1273.214 (bivalent wild type and omicron B.1.1.529 variants), 5 NVSI-06-08 (recombinant protein vaccine, three heterologous RBDs from the prototype, Beta and Kappa SARS-CoV-2 strain, Sinopharm) 11 and V-01D-351 (recombinant protein vaccine, bivalent from Beta and Delta, Livzon) 12 are in progress.…”

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial

Hannawi¹,

Saifeldin²,

Abuquta³

et al. 2023

eBioMedicine

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Section: Discussionmentioning

confidence: 71%

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial

Hannawi¹,

Saifeldin²,

Abuquta³

et al. 2023

eBioMedicine

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“…2) NVSI-06-08 is a recombinant COVID-19 vaccine based on the antigen of a mutation-integrated trimetric RBD developed by Sinopharm. In the Phase-2 trial, the neutralising Ab titres against Omicron was increased to 368 (95% CI: 296-457) among participants who had received BBIBP-CorV as their primary course and NVSI-06-08 as the third dose 21 .…”

Section: 3mentioning

confidence: 99%

Modelling the adjustment of COVID-19 response and exit from dynamic zero-COVID in China

Leung

2022

Preprint

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Background Since the initial Wuhan outbreak, China has been containing COVID-19 outbreaks through its "dynamic zero-COVID" policy. Striking a balance between sustainability and cost-benefit, China has recently begun to adjust its COVID-19 response strategies, e.g. by announcing the "20 measures" on 11 November and further the "10 measures" on 7 December 2022. Strategies for safely exiting from dynamic zero-COVID (i.e. without catastrophically overburdening health systems and/or incurring unacceptably excessive morbidity and mortality) are urgently needed. Methods We use simulations to assess the respective and combined effectiveness of fourth-dose heterologous boosting, large-scale antiviral treatment and public health and social measures (PHSMs) that might allow China to further adjust COVID-19 response and exit from zero-COVID safely after 7 December 2022. We also assess whether local health systems can cope with the surge of COVID-19 cases posed by reopening, given that chunyun, a 40-day period with extremely high mobility across China associated with Spring Festival, will begin on 7 January 2023. Findings Reopening against Omicron transmission should be supported by the following interventions: 1) fourth-dose heterologous boosting 30-60 days before reopening by vaccinating 4-8% of the population per week with ≥85% uptake across all ages; 2) timely antiviral treatment with ≥60% coverage; 3) moderate PHSMs to reduce transmissibility by 47-69%. With fourth-dose vaccination coverage of 85% and antiviral coverage of 60%, the cumulative mortality burden would be reduced by 26-35% to 448-503 per million, compared with reopening without any of these interventions. Simultaneously reopening all provinces under current PHSMs would still lead to hospitalization demand that are 1.5-2.5 times of surge hospital capacity (2.2 per 10,000 population per day). Interpretation Although the surge of disease burden posed by reopening in December 2022-January 2023 would likely overload many local health systems across the country, the combined effect of vaccination, antiviral treatment and PHSMs could substantially reduce COVID-19 morbidity and mortality as China transits from dynamic-zero to normality. Planning for such a nationwide, coordinated reopening should be an urgent priority as part of the global exit from the acute phase of the COVID-19 pandemic.

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“…Epitopes in less accessible regions of the RBD are more conserved among circulating coronaviruses, consistent with Abs targeting these regions being able to cross-neutralize other coronaviruses [21,25,26]. Several groups have developed adjuvanted RBD only vaccines based on monomeric or multivalent display of the RBD, with several human phase I/II and phase III trials showing a safe and immunogenic response, thus making the RBD, or S in the RBD-open state, an attractive vaccine antigen [27][28][29][30][31][32][33][34][35][36][37].…”

Section: Introductionmentioning

confidence: 74%

“…The copyright holder for this preprint this version posted November 29, 2022. ; https://doi.org/10.1101/2022.11.29.518231 doi: bioRxiv preprint have developed adjuvanted RBD only vaccines based on monomeric or multivalent display of the RBD, with several human phase I/II and phase III trials showing a safe and immunogenic response, thus making the RBD, or S in the RBD-open state, an attractive vaccine antigen [27][28][29][30][31][32][33][34][35][36][37].…”

Section: Introductionmentioning

confidence: 99%

Structural and Computational Design of a SARS-2 Spike Antigen with Increased Receptor Binding Domain Exposure and Improved Immunogenicity

Williams

Biancucci

Lessen

et al. 2022

Preprint

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Emerging SARS-CoV-2 variants of concern challenge the efficacy of approved vaccines and emphasize the need for improved antigens. Using an evolutionary-based design approach starting from the widely used engineered Spike antigen, S-2P, we sought to increase antigen production levels and the exposure of highly conserved and neutralization sensitive receptor-binding domain (RBD) epitopes. Thirty-six prototypes were generatedin silico, of which fifteen were produced and tested in biochemical assays. Design S2D14, which contains 20 mutations within the Spike S2 domain, showed a 6-fold increase in expression while preserving similar thermal stability and antigenicity as S-2P. Cryo-EM structures indicate that the dominant populations of S2D14 particles have RBDs in exposed states, and analysis of these structures revealed how modifications within the S2 domain balance trimer stability and RBD accessibility through formation and removal of hydrogen bonds and surface charge alterations. Importantly, vaccination of mice with adjuvanted S2D14 resulted in higher levels of neutralizing antibodies than adjuvanted S-2P against SARS-CoV-2 Wuhan strain and four variants of concern. These results can guide the design of next generation vaccines to combat current, and future coronaviruses and the approaches used may be broadly applicable to streamline the successful design of vaccine antigens.

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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Cited by 32 publications

References 23 publications

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial

Modelling the adjustment of COVID-19 response and exit from dynamic zero-COVID in China

Structural and Computational Design of a SARS-2 Spike Antigen with Increased Receptor Binding Domain Exposure and Improved Immunogenicity

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