Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine

Human Vaccines & Immunotherapeutics, Год журнала: 2024, Номер 20(1)

Опубликована: Июнь 5, 2024

Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is recombinant spike trimer manufactured in insect cells formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret non-human primate studies, consistently provided protection against range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability to prevent infection severe disease caused by virulent Delta strain. subsequently received marketing authorization from Iranian FDA early October 2021 prevention COVID-19 adults. Following successful pediatric study, its approval was extended children 5 years older. Eight million doses have been delivered, next-generation booster version currently development. This highlights benefits adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected future pandemics.

Язык: Английский

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Immunogenicity and safety study of a single dose of SpikoGen® vaccine as a heterologous or homologous intramuscular booster following a primary course of mRNA, adenoviral vector or recombinant protein COVID-19 vaccine in ambulatory adults

Vaccine, Год журнала: 2025, Номер 49, С. 126744 - 126744

Опубликована: Фев. 5, 2025

Язык: Английский

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Immune Response Against Recent Omicron Sub-Lineages in Persons with HIV Receiving a Protein-Based or mRNA XBB.1.5 SARS-CoV-2 Booster Vaccine

International Journal of Molecular Sciences, Год журнала: 2025, Номер 26(8), С. 3521 - 3521

Опубликована: Апрель 9, 2025

The new Nuvaxovid protein-based and Pfizer-BioNTech mRNA-based vaccines targeting Omicron XBB.1.5 were available during the 2023–2024 autumn/winter vaccination campaign for frail individuals, including people with HIV (PWH). We assessed immune response in 51 PWH on stable ART who received a booster either (n = 25) or vaccine 26). median age was 57 years (IQR 51–65), count of CD4 at T0 652/mmc (503–935), nadir 226/mmc (95–340). Samples collected before (T0) one month after (T1) booster. measured neutralizing antibodies (nAbs) titers against D614G, XBB.1.6, JN.1 variants T-cell IFN-γ levels produced upon specific stimulation. Regardless used, we observed marked increase nAbs from to T1 all subvariants, but no evidence change release. After controlling confounders, there difference T0-T1 XBB.1.16 by type vaccine, while determined smaller D614G (p 0.008). vaccine’s immunogenicity as fifth later comparable mRNA particularly recent variants.

Язык: Английский

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Post-Hoc Analysis of Potential Correlates of Protection of a Recombinant SARS-CoV-2 Spike Protein Extracellular Domain Vaccine Formulated with Advax-CpG55.2-Adjuvant

International Journal of Molecular Sciences, Год журнала: 2024, Номер 25(17), С. 9459 - 9459

Опубликована: Авг. 30, 2024

SpikoGen® vaccine is a subunit COVID-19 composed of an insect cell expressed recombinant spike protein extracellular domain formulated with Advax-CpG55.2™ adjuvant. A randomized double-blind, placebo-controlled Phase II clinical trial was conducted in 400 adult subjects who were 3:1 to receive two intramuscular doses three weeks apart either 25 μg or saline placebo, as previously reported. This study reports post hoc analysis the data explore potential immune correlates protection. range humoral markers collected pre- and post-vaccination, including spike- RBD-binding IgG IgA, surrogate (sVNT), conventional (cVNT) virus neutralization tests compared between participants remained infection-free got infected over months follow-up. From 2 after second dose, 21 diagnosed SARS-CoV-2 infection, 13 (4.2%) group 8 (9%) placebo group. Those vaccinated experienced breakthrough infections had significantly lower sVNT titers (GMT 5.75 μg/mL, 95% CI; 3.72–8.91) dose (day 35) than those did not get 21.06 16.57–26.76). Conversely, develop infection during follow-up higher baseline sVNT, cVNT, spike-binding IgG, consistent past infection. further reduced risk re-infection (OR 0.29) seropositive (previously infected) well seronegative participants. indicates that while SpikoGen protective individuals, hybrid immunity have most robust

Язык: Английский

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Coronavirus spike protein-based vaccines. Vaccine delivery systems

Medicine in Drug Discovery, Год журнала: 2024, Номер unknown, С. 100198 - 100198

Опубликована: Сен. 1, 2024

Язык: Английский

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