Covax-19/Spikogen® vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters

Li, Lei; Honda‐Okubo, Yoshikazu; Baldwin, Jeremy; Bowen, Richard A.; Bielefeldt‐Ohmann, Helle; Petrovsky, Nikolai

doi:10.1016/j.vaccine.2022.04.041

Cited by 31 publications

(21 citation statements)

References 45 publications

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“…Previous studies of the SpikoGen® showed robust protection against SARS-CoV-2 challenge test along with induction of neutralizing antibodies and T cell responses [4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 91%

Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2–adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial

Tabarsi

Anjidani²,

Shahpari³

et al. 2023

Clinical Microbiology and Infection

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“…Previous studies of the SpikoGen® showed robust protection against SARS-CoV-2 challenge test along with induction of neutralizing antibodies and T cell responses [4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 91%

Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2–adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial

Tabarsi

Anjidani²,

Shahpari³

et al. 2023

Clinical Microbiology and Infection

Self Cite

View full text Add to dashboard Cite

“…Spikogen vaccine, also called as Cova-19, developed by Australia Vaxine Pvt Ltd. together with Iranian biotech company Cinnagen. The vaccine works on the basis of a monovalent recombinant protein [ 187 ]. It has been approved for emergency use in Iran.…”

Section: Vaccine Candidates Approved Against Sars-cov-2 Infectionmentioning

confidence: 99%

Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness

et al. 2022

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The incidence and death toll due to SARS-CoV-2 infection varied time-to-time; and depended on several factors, including severity (viral load), immune status, age, gender, vaccination status, and presence of comorbidities. The RNA genome of SARS-CoV-2 has mutated and produced several variants, which were classified by the SARS-CoV-2 Interagency Group (SIG) into four major categories. The first category; “Variant Being Monitored (VBM)”, consists of Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427, B.1.429), Eta (B.1.525), Iota (B.1.526), Kappa (B.1.617.1), Mu (B.1.621), and Zeta (P.2); the second category; “Variants of Concern” consists of Omicron (B.1.1.529). The third and fourth categories include “Variants of Interest (VOI)”, and “Variants of High Consequence (VOHC)”, respectively, and contain no variants classified currently under these categories. The surge in VBM and VOC poses a significant threat to public health globally as they exhibit altered virulence, transmissibility, diagnostic or therapeutic escape, and the ability to evade the host immune response. Studies have shown that certain mutations increase the infectivity and pathogenicity of the virus as demonstrated in the case of SARS-CoV-2, the Omicron variant. It is reported that the Omicron variant has >60 mutations with at least 30 mutations in the Spike protein (“S” protein) and 15 mutations in the receptor-binding domain (RBD), resulting in rapid attachment to target cells and immune evasion. The spread of VBM and VOCs has affected the actual protective efficacy of the first-generation vaccines (ChAdOx1, Ad26.COV2.S, NVX-CoV2373, BNT162b2). Currently, the data on the effectiveness of existing vaccines against newer variants of SARS-CoV-2 are very scanty; hence additional studies are immediately warranted. To this end, recent studies have initiated investigations to elucidate the structural features of crucial proteins of SARS-CoV-2 variants and their involvement in pathogenesis. In addition, intense research is in progress to develop better preventive and therapeutic strategies to halt the spread of COVID-19 caused by variants. This review summarizes the structure and life cycle of SARS-CoV-2, provides background information on several variants of SARS-CoV-2 and mutations associated with these variants, and reviews recent studies on the safety and efficacy of major vaccines/vaccine candidates approved against SARS-CoV-2, and its variants.

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“…Interestingly, adjuvanted antigen generates a robust antibody response even after a single dose, but a 2-dose strategy worked better overall and required just half as much antigen. There was a reduced viral load in oropharyngeal swab and nasal turbinate tissue and no live infectious virus in lung tissue in immunized mice post 3 days [ 51 ]. The Covax-19 (Vaxine/CinnaGen Co.: SpikoGen) adjuvanted with advax has been referred for clinical trials in Iran and Australia after gaining long-lasting protection with superior safety and tolerability findings from pre-clinical tests on mice, ferrets, and monkeys (Phase I, II) (NCT05005559, NCT05148871, NCT05175625) [ 51 , 53 ].…”

Section: Covid-19 Vaccines and Immune-adjuvantsmentioning

confidence: 99%

“…There was a reduced viral load in oropharyngeal swab and nasal turbinate tissue and no live infectious virus in lung tissue in immunized mice post 3 days [ 51 ]. The Covax-19 (Vaxine/CinnaGen Co.: SpikoGen) adjuvanted with advax has been referred for clinical trials in Iran and Australia after gaining long-lasting protection with superior safety and tolerability findings from pre-clinical tests on mice, ferrets, and monkeys (Phase I, II) (NCT05005559, NCT05148871, NCT05175625) [ 51 , 53 ]. Recently, Iran has officially given emergency authorisation for the use of the SpikoGen vaccine in combination with Advax to prevent SARS-CoV-2 infection.…”

Section: Covid-19 Vaccines and Immune-adjuvantsmentioning

confidence: 99%

Plant-derived immuno-adjuvants in vaccines formulation: a promising avenue for improving vaccines efficacy against SARS-CoV-2 virus

et al. 2022

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The SARS-CoV-2 outbreak has posed a plethora of problems for the global healthcare system and socioeconomic burden. Despite valiant efforts to contain the COVID-19 outbreak, the situation has deteriorated to the point that there are no viable preventive therapies to treat this disease. The case count has skyrocketed globally due to the newly evolved variants. Despite vaccination drives, the re-occurrence of recent pandemic waves has reinforced the importance of innovation/utilization of immune-booster to achieve appropriate long-term vaccine protection. Plant-derived immuno-adjuvants, which have multifaceted functions, can impede infections by boosting the immune system. Many previous studies have shown that formulation of vaccines using plant-derived adjuvant results in long-lasting immunity may overcome the natural tendency of coronavirus immunity to wane quickly. Plant polysaccharides, glycosides, and glycoprotein extracts have reportedly been utilized as enticing adjuvants in experimental vaccines, such as Advax, Matrix-M, and Mistletoe lectin, which have been shown to be highly immunogenic and safe. When employed in vaccine formulation, Advax and Matrix-M generate long-lasting antibodies, a balanced robust Th1/Th2 cytokine profile, and the stimulation of cytotoxic T cells. Thus, the use of adjuvants derived from plants may increase the effectiveness of vaccines, resulting in the proper immunological response required to combat COVID-19. A few have been widely used in epidemic outbreaks, including SARS and H1N1 influenza, and their use could also improve the efficacy of COVID-19 vaccines. In this review, the immunological adjuvant properties of plant compounds as well as their potential application in anti-COVID-19 therapy are thoroughly discussed.

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Covax-19/Spikogen® vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters

Cited by 31 publications

References 45 publications

Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2–adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial

Evaluating the efficacy and safety of SpikoGen®, an Advax-CpG55.2–adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial

Variants of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Vaccine Effectiveness

Plant-derived immuno-adjuvants in vaccines formulation: a promising avenue for improving vaccines efficacy against SARS-CoV-2 virus

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