Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men

Hannawi, Suad; Saifeldin, Linda; Abuquta, Alaa; Alamadi, Ahmad; Mahmoud, Sally; Hassan, Aala; Xu, Shengyuan; Li, Jian; Liu, Dongfang; Baidoo, Adam Abdul Hakeem; Ibrahim, DA; Alhaj, M; Chen, Yuanxin; Zhang, Qiang; Xie, Liangzhi

doi:10.1038/s41467-023-39766-x

Cited by 12 publications

(6 citation statements)

References 23 publications

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“…Multiple clinical trials, conducted in China and the United Arab Emirates, have assessed its safety, tolerability, immunogenicity, and protective efficacy. Phase 3 clinical data suggest SCTV01E’s effectiveness as a booster shot against Omicron and its subvariants, including XBB, with no significant adverse events reported 18 . The vaccine has been approved for emergency use in China as of March and is now being administered in multiple cities.…”

Section: Introductionmentioning

confidence: 99%

Enhanced neutralization of SARS-CoV-2 XBB sub-lineages and BA.2.86 by a tetravalent COVID-19 vaccine booster

Wang,

Jiang,

et al. 2023

Preprint

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As the SARS-CoV-2 virus continues to evolve, novel XBB sub-lineages such as XBB.1.5, XBB.1.16, EG.5, HK.3 (FLip), and XBB.2.3, as well as the most recent BA.2.86, have been identified and aroused global concern. Understanding the efficacy of current vaccines and the immune system's response to these emerging variants is critical for global public health. In this study, we evaluated the neutralization activities of sera from participants who received COVID-19 inactivated vaccines, or a booster vaccination of the recently approved tetravalent protein vaccine in China (SCTV01E), or had contracted a breakthrough infection with BA.5/BF.7/XBB virus. Comparative analysis of their neutralization profiles against a broad panel of 30 SARS-CoV-2 sub-lineage viruses revealed that strains such as BQ.1.1, CH.1.1, and all the XBB sub-lineages exhibited heightened resistance to neutralization than previous variants, however, despite the extra mutations carried by emerging XBB sub-lineages and BA.2.86, they did not demonstrate significantly increased resistance to neutralization compared to XBB.1.5. Encouragingly, the SCTV01E booster vaccination consistently induced robust and considerably higher neutralizing titers against all these variants than breakthrough infection did. Cellular immunity assays also showed that the SCTV01E booster vaccination elicited a higher frequency of virus-specific memory B cells but not IFN-γ secreting T cells. Our findings underline the importance of developing novel multivalent vaccines to more effectively combat future viral variants.

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Section: Introductionmentioning

confidence: 99%

Enhanced neutralization of SARS-CoV-2 XBB sub-lineages and BA.2.86 by a tetravalent COVID-19 vaccine booster

Wang,

Jiang,

et al. 2023

Preprint

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“…One trial exclusively included healthy older adults (≥ 60 years) [ 37 ]. Most trials assessed a third dose heterologous booster vaccine compared with a third dose homologous booster vaccine [ 28 – 53 ] while four trials compared a fourth heterologous booster with a fourth homologous booster [ 47 , 54 – 56 ]. The included heterologous booster vaccines encompassed viral-vectored, mRNA, protein subunit, or inactivated virus platforms (Table 2 : Trials’ characteristics).…”

Section: Resultsmentioning

confidence: 99%

Heterologous versus homologous COVID-19 booster vaccinations for adults: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials

Asante,

Michelsen,

Balakumar

et al. 2024

BMC Med

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Background To combat coronavirus disease 2019 (COVID-19), booster vaccination strategies are important. However, the optimal administration of booster vaccine platforms remains unclear. Herein, we aimed to assess the benefits and harms of three or four heterologous versus homologous booster regimens. Methods From November 3 2022 to December 21, 2023, we searched five databases for randomised clinical trials (RCT). Reviewers screened, extracted data, and assessed bias risks independently with the Cochrane risk-of-bias 2 tool. We conducted meta-analyses and trial sequential analyses (TSA) on our primary (all-cause mortality; laboratory confirmed symptomatic and severe COVID-19; serious adverse events [SAE]) and secondary outcomes (quality of life [QoL]; adverse events [AE] considered non-serious). We assessed the evidence with the GRADE approach. Subgroup analyses were stratified for trials before and after 2023, three or four boosters, immunocompromised status, follow-up, risk of bias, heterologous booster vaccine platforms, and valency of booster. Results We included 29 RCTs with 43 comparisons (12,538 participants). Heterologous booster regimens may not reduce the relative risk (RR) of all-cause mortality (11 trials; RR 0.86; 95% CI 0.33 to 2.26; I2 0%; very low certainty evidence); laboratory-confirmed symptomatic COVID-19 (14 trials; RR 0.95; 95% CI 0.72 to 1.25; I2 0%; very low certainty); or severe COVID-19 (10 trials; RR 0.51; 95% CI 0.20 to 1.33; I2 0%; very low certainty). For safety outcomes, heterologous booster regimens may have no effect on SAE (27 trials; RR 1.15; 95% CI 0.68 to 1.95; I2 0%; very low certainty) but may raise AE considered non-serious (20 trials; RR 1.19; 95% CI 1.08 to 1.32; I2 64.4%; very low certainty). No data on QoL was available. Our TSAs showed that the cumulative Z curves did not reach futility for any outcome. Conclusions With our current sample sizes, we were not able to infer differences of effects for any outcomes, but heterologous booster regimens seem to cause more non-serious AE. Furthermore, more robust data are instrumental to update this review.

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“…The PRNT50 of BA.5 in group 2 was 1.46 times higher than that of BA.1 (1736 vs. 1189). In group 3, the PRNT50 of BA.5 was 1.37 times higher than that of BA.1 (2281 vs. 1659) ( 77 ). SCTV01E is a tetravalent vaccine formed by the addition of OmicronBA.1 and Delta (B.1.617.2) spike-ECD protein mixtures to the SCTV01C (Alpha + Beta) bivalent vaccine.…”

Section: Effect Of Heterologous Inoculation On the Effectiveness Of O...mentioning

confidence: 88%

“…It is safe and immunogenic as a heterologous vaccine in vaccinated individuals, inducing robust humoral and antibody responses. The SCTV01E S trimer protein vaccine consists of four variants: Alpha, Beta, Delta, and Omicron BA.1 ( 77 ). It employs a novel oil-in-water adjuvant of Th1 cells to offer enhanced protection against SARS-CoV-2.…”

Section: Universal Vaccinesmentioning

confidence: 99%

Analysis of the protective efficacy of approved COVID-19 vaccines against Omicron variants and the prospects for universal vaccines

Chen,

Zhang,

Fang

et al. 2023

Front. Immunol.

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By the end of 2022, different variants of Omicron had rapidly spread worldwide, causing a significant impact on the Coronavirus disease 2019 (COVID-19) pandemic situation. Compared with previous variants of severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2), these new variants of Omicron exhibited a noticeable degree of mutation. The currently developed platforms to design COVID-19 vaccines include inactivated vaccines, mRNA vaccines, DNA vaccines, recombinant protein vaccines, virus-like particle vaccines, and viral vector vaccines. Many of these platforms have obtained approval from the US Food and Drug Administration (FDA) or the WHO. However, the Omicron variants have spread in countries where vaccination has taken place; therefore, the number of cases has rapidly increased, causing concerns about the effectiveness of these vaccines. This article first discusses the epidemiological trends of the Omicron variant and reviews the latest research progress on available vaccines. Additionally, we discuss progress in the development progress and practical significance of universal vaccines. Next, we analyze the neutralizing antibody effectiveness of approved vaccines against different variants of Omicron, heterologous vaccination, and the effectiveness of multivalent vaccines in preclinical trials. We hope that this review will provide a theoretical basis for the design, development, production, and vaccination strategies of novel coronavirus vaccines, thus helping to end the SARS-CoV-2 pandemic.

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Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men

Cited by 12 publications

References 23 publications

Enhanced neutralization of SARS-CoV-2 XBB sub-lineages and BA.2.86 by a tetravalent COVID-19 vaccine booster

Enhanced neutralization of SARS-CoV-2 XBB sub-lineages and BA.2.86 by a tetravalent COVID-19 vaccine booster

Heterologous versus homologous COVID-19 booster vaccinations for adults: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials

Analysis of the protective efficacy of approved COVID-19 vaccines against Omicron variants and the prospects for universal vaccines

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