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

Hannawi, Suad; Saifeldin, Linda; Abuquta, Alaa; Alamadi, Ahmad; Mahmoud, S. A.; Hassan, Aala; Liu, Dongfang; Liu, Yan; Xie, Liangzhi

doi:10.1016/j.ebiom.2022.104386

Cited by 20 publications

(26 citation statements)

References 28 publications

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“…Immune escape of SARS-CoV-2 and antibody fade led to the loss of protection against omicron VOC during the last months. Booster vaccination is an efficient way to address the waning protection of vaccines 2 and a new bivalent (Original and omicron BA.4/5) adapted vaccine demonstrated robust neutralizing antibody response in Phase 2/3 clinical trial 3 . Immunogenicity of this new bivalent COVID-19 vaccine in hemodialysis patients has been not evaluated so far.…”

mentioning

confidence: 99%

Immunogenicity of Bivalent Omicron BA.4/5–Adapted Vaccine in Hemodialysis Patients

Anft¹,

Skrzypczyk²,

Frahnert³

et al. 2023

Kidney International Reports

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mentioning

confidence: 99%

Immunogenicity of Bivalent Omicron BA.4/5–Adapted Vaccine in Hemodialysis Patients

Anft¹,

Skrzypczyk²,

Frahnert³

et al. 2023

Kidney International Reports

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“…No large human studies are available on updated mRNA products, which encode for two types of Spike proteins at the same time, regarding protection from the disease. In a recent report, immunogenicity of the bivalent vaccine was studied after 28 days, but the safety assessment stopped at day 7 [ 200 ]. Compared to other variants, the Omicron variant has at least three times more affinity for ACE2 (affinity is based on Spike protein interaction with its receptor) [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases, in Patients with Cardiac Issues, and in the Healthy Population

2023

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The coronavirus disease 2019 (COVID-19) has been a challenge for the whole world since the beginning of 2020, and COVID-19 vaccines were considered crucial for disease eradication. Instead of producing classic vaccines, some companies pointed to develop products that mainly function by inducing, into the host, the production of the antigenic protein of SARS-CoV-2 called Spike, injecting an instruction based on RNA or a DNA sequence. Here, we aim to give an overview of the safety profile and the actual known adverse effects of these products in relationship with their mechanism of action. We discuss the use and safety of these products in at-risk people, especially those with autoimmune diseases or with previously reported myocarditis, but also in the general population. We debate the real necessity of administering these products with unclear long-term effects to at-risk people with autoimmune conditions, as well as to healthy people, at the time of omicron variants. This, considering the existence of therapeutic interventions, much more clearly assessed at present compared to the past, and the relatively lower aggressive nature of the new viral variants.

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“…Due to various concerns, including the longevity of protection and the association of adenovirus and mRNA-based vaccines with rare, but serious side effects, different vaccine platforms are still being actively evaluated to produce new vaccines to target SARS-CoV-2 variants (22). For example, a few protein subunit variantbased vaccine formulations have also been assessed clinically in the context of a booster dose (23)(24)(25). Also, bivalent or multivalent protein vaccine formulations have been used to both prime and boost immune responses within a preclinical setting, resulting in an increased breadth of the neutralization response (16,26).…”

Section: Neutralizing Activitymentioning

confidence: 99%

Tuning the immune response: sulfated archaeal glycolipid archaeosomes as an effective vaccine adjuvant for induction of humoral and cell-mediated immunity towards the SARS-CoV-2 Omicron variant of concern

et al. 2023

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Liposomes composed of sulfated lactosyl archaeol (SLA) have been shown to be a safe and effective vaccine adjuvant with a multitude of antigens in preclinical studies. In particular, SLA-adjuvanted SARS-CoV-2 subunit vaccines based on trimeric spike protein antigens were shown to be immunogenic and efficacious in mice and hamsters. With the continued emergence of SARS-CoV-2 variants, we sought to evaluate next-generation vaccine formulations with an updated antigenic identity. This was of particular interest for the widespread Omicron variant, given the abundance of mutations and structural changes observed within its spike protein compared to other variants. An updated version of our resistin-trimerized SmT1 corresponding to the B.1.1.529 variant was successfully generated in our Chinese Hamster Ovary (CHO) cell-based antigen production platform and characterized, revealing some differences in protein profile and ACE2 binding affinity as compared to reference strain-based SmT1. We next evaluated this Omicron-based spike antigen for its immunogenicity and ability to generate robust antigen-specific immune responses when paired with SLA liposomes or AddaS03 (a mimetic of the AS03 oil-in-water emulsion adjuvant system found in commercialized SARS-CoV-2 protein vaccines). Immunization of mice with vaccine formulations containing this updated antigen with either adjuvant stimulated neutralizing antibody responses favouring Omicron over the reference strain. Cell-mediated responses, which play an important role in the neutralization of intracellular infections, were induced to a much higher degree with the SLA adjuvant relative to the AddaS03-adjuvanted formulations. As such, updated vaccines that are better capable of targeting towards SARS-CoV-2 variants can be generated through an optimized combination of antigen and adjuvant components.

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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

Cited by 20 publications

References 28 publications

Immunogenicity of Bivalent Omicron BA.4/5–Adapted Vaccine in Hemodialysis Patients

Immunogenicity of Bivalent Omicron BA.4/5–Adapted Vaccine in Hemodialysis Patients

Safety of COVID-19 Vaccines in Patients with Autoimmune Diseases, in Patients with Cardiac Issues, and in the Healthy Population

Tuning the immune response: sulfated archaeal glycolipid archaeosomes as an effective vaccine adjuvant for induction of humoral and cell-mediated immunity towards the SARS-CoV-2 Omicron variant of concern

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