An overview of the vaccine platforms to combat COVID-19 with a focus on the subunit vaccines

Bayani, Fatemeh; Hashkavaei, Negin Safaei; Arjmand, Sareh; Rezaei, Shokouh; Uskoković, Vuk; Alijanianzadeh, Mahdi; Uversky, Vladimir N.; Siadat, Seyed Omid Ranaei; Mozaffari‐Jovin, Sina; Sefidbakht, Yahya

doi:10.1016/j.pbiomolbio.2023.02.004

Cited by 35 publications

(20 citation statements)

References 176 publications

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“…The outbreak of the coronavirus disease (COVID-19) in December 2019 has raised the need to establish new effective and versatile vaccine platforms, whose adaptation to potential future threats is reasonably fast and technically plausible . Among the vaccinal strategies that responded to the COVID-19 urgency were the new mRNA and recombinant adenovirus vectorized vaccines, as well as the more traditional vaccines consisting of inactivated virus particles and subunit vaccines based on recombinant viral proteins. , In this context, the receptor binding domain (RBD) protein has been selected as the core antigen of most vaccine formulations. The RBD is a region of the SARS-CoV-2 spike protein that mediates the binding to host cell angiotensin-converting enzyme receptors that are widely expressed in epithelial cells of the lungs, heart, kidney, and intestine …”

Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Nanovaccine Composed of Microfluidic-Produced Gold Nanoparticles Induces Neutralizing Immune Responses

Dalibera,

Rodrigues-Jesus,

Andreata-Santos

et al. 2023

ACS Appl. Nano Mater.

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Section: Introductionmentioning

confidence: 99%

SARS-CoV-2 Nanovaccine Composed of Microfluidic-Produced Gold Nanoparticles Induces Neutralizing Immune Responses

Dalibera,

Rodrigues-Jesus,

Andreata-Santos

et al. 2023

ACS Appl. Nano Mater.

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“…18 Moreover, it reinforces the notion that adjuvanted protein subunit vaccines, such as PHH-1V81, are particularly well-suited for vulnerable populations, including immunocompromised individuals, due to their safety profile and their ability to generate high levels of neutralizing antibodies, surpassing those induced by inactivated virus vaccines. 26…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and safety of an Omicron XBB.1.16 adapted vaccine for COVID-19: Interim results from a randomized, controlled, non-inferiority clinical trial

López Fernandez,

Narejos,

Castro

et al. 2024

Preprint

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Background Global COVID-19 vaccination adapts to protect populations from emerging variants. This communication presents interim findings from the new Omicron XBB adapted PHH-1V81 vaccine compared to a XBB adapted mRNA vaccine against XBB and JN.1 SARS-CoV-2 strains. Methods In a Phase IIb/III pivotal trial, adults previously vaccinated with a primary scheme and at least one booster dose of an EU-approved mRNA vaccine randomly received either PHH-1V81 or BNT162b2 XBB.1.5 vaccine booster as a single dose. The primary efficacy endpoint assessed neutralisation titers against the Omicron XBB.1.16 variant at day 14. Secondary endpoints evaluated neutralization titers and cellular immunity against different variants. Safety endpoints comprised solicited reactions up to day 7 post-vaccination and serious adverse events until the cut-off date of the interim analysis. Changes in humoral responses were reported as GMT and GMFR assessed by PBNA or VNA. Results At the cut-off date, immunogenicity assessments included 599 participants. Both boosters elicited neutralizing antibodies against XBB.1.5, XBB.1.16 and JN.1 with PHH-1V81 inducing a higher response for all variants. PHH-1V8 booster triggers a superior neutralizing antibodies response against XBBs variants compared to the mRNA vaccine. Subgroup analysis consistently revealed higher neutralizing antibody responses with PHH-1V81 across age groups, number of prior vaccination shots, and SARS-CoV-2 infection history. Safety analysis involved 607 participants at the day 14 visit, revealing favourable safety profiles without any serious vaccine-related adverse events at cut-off date of the interim analysis (12th December 2023). Conclusions PHH-1V81 demonstrates superiority on humoral immunogenicity compared to mRNA vaccine agains XBB variants and non-inferiority against JN.1 with favourable safety profile and lower reactogenicity, confirming its potential as vaccine candidate. Trial registration numbers:NCT06181292; EU CT No: 2023-508458-25-00

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“…Such is the case of NVX-CoV2373 (marketed as Novavax), the first recombinant subunit vaccine with emergency use authorization (EUA) by FDA for the USA and with WHO-EUA for 38 other countries (FDA 2022 ). There are also 12 different subunit vaccines based on spike or RBD sequence which have been currently approved in one or more countries (Bayani et al 2023 ). However, it is important to consider that the efficacy of a recombinant protein subunit vaccine can be greatly enhanced by the co-administration of an adjuvant (Mandolesi et al 2021 ; Martínez-Flores et al 2021 ).…”

Section: Discussionmentioning

confidence: 99%

A COVID-19 vaccine candidate based on SARS-CoV-2 spike protein and immune-stimulating complexes

Villarraza

Fuselli

Gugliotta

et al. 2023

Appl Microbiol Biotechnol

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Spike protein from SARS-CoV-2, the etiologic agent of the COVID-19 pandemic disease, constitutes a structural protein that proved to be the main responsible for neutralizing antibody production. Thus, its sequence is highly considered for the design of candidate vaccines. Animal cell culture represents the best option for the production of subunit vaccines based on recombinant proteins since they introduce post-translational modifications that are important to mimic the natural antigenic epitopes. Particularly, the human cell line HEK293T has been explored and used for the production of biotherapeutics since the products derived from them present human-like post-translational modifications that are important for the protein’s activity and immunogenicity. The aim of this study was to produce and characterize a potential vaccine for COVID-19 based on the spike ectodomain (S-ED) of SARS-CoV-2 and two different adjuvants: aluminum hydroxide (AH) and immune-stimulating complexes (ISCOMs). The S-ED was produced in sHEK293T cells using a 1-L stirred tank bioreactor operated in perfusion mode and purified. S-ED characterization revealed the expected size and morphology. High N-glycan content was confirmed. S-ED-specific binding with the hACE2 (human angiotensin-converting enzyme 2) receptor was verified. The immunogenicity of S-ED was evaluated using AH and ISCOMs. Both formulations demonstrated the presence of anti-RBD antibodies in the plasma of immunized mice, being significantly higher for the latter adjuvant. Also, higher levels of IFN-γ and IL-4 were detected after the ex vivo immune stimulation of spleen-derived MNCs from ISCOMs immunized mice. Further analysis confirmed that S-ED/ISCOMs elicit neutralizing antibodies against SARS-CoV-2. Key points Trimeric SARS-CoV-2 S-ED was produced in stable recombinant sHEK cells in serum-free medium. A novel S-ED vaccine formulation induced potent humoral and cellular immunity. S-ED formulated with ISCOMs adjuvant elicited a highly neutralizing antibody titer. Supplementary Information The online version contains supplementary material available at 10.1007/s00253-023-12520-5.

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An overview of the vaccine platforms to combat COVID-19 with a focus on the subunit vaccines

Cited by 35 publications

References 176 publications

SARS-CoV-2 Nanovaccine Composed of Microfluidic-Produced Gold Nanoparticles Induces Neutralizing Immune Responses

SARS-CoV-2 Nanovaccine Composed of Microfluidic-Produced Gold Nanoparticles Induces Neutralizing Immune Responses

Immunogenicity and safety of an Omicron XBB.1.16 adapted vaccine for COVID-19: Interim results from a randomized, controlled, non-inferiority clinical trial

A COVID-19 vaccine candidate based on SARS-CoV-2 spike protein and immune-stimulating complexes

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