Preparation of Bovine Coronavirus Virus-Like Particles and its Immunogenicity in Mice and Cattle DOI

Qisheng Yu,

Qing Zhu,

Xiangyue Huang

и другие.

Опубликована: Янв. 1, 2024

Язык: Английский

Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine DOI Creative Commons
Nikolai Petrovsky

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

Процитировано

6
Study of immunogenicity and efficacy against Omicron BA.5 of recombinant protein-based COVID-19 vaccine delivered by intramuscular and mucosal routes in nonhuman primates DOI

Ranajit Pal,

Maria Grazia Ferrari,

Yoshikazu Honda‐Okubo

и другие.

Vaccine, Год журнала: 2024, Номер 42(5), С. 1122 - 1135

Опубликована: Янв. 22, 2024

Язык: Английский

Процитировано

5
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 DOI
Yoshikazu Honda‐Okubo, Dimitar Sajkov,

Bruce A. Wauchope

и другие.

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

Опубликована: Фев. 5, 2025

Язык: Английский

Процитировано

0
Comparative immunogenicity and safety of SpikoGen®, a recombinant SARS-CoV-2 spike protein vaccine in children and young adults: An immuno-bridging clinical trial DOI
Payam Tabarsi, Setareh Mamishi, Nassim Anjidani

и другие.

International Immunopharmacology, Год журнала: 2023, Номер 127, С. 111436 - 111436

Опубликована: Дек. 25, 2023

Язык: Английский

Процитировано

5
Multivalent and Sequential Heterologous Spike Protein Vaccinations Effectively Induce Protective Humoral Immunity against SARS-CoV-2 Variants DOI Creative Commons
Rong Liu, Janhavi P. Natekar,

Ki‐Hye Kim

и другие.

Vaccines, Год журнала: 2024, Номер 12(4), С. 362 - 362

Опубликована: Март 27, 2024

The emergence of new SARS-CoV-2 variants continues to cause challenging problems for the effective control COVID-19. In this study, we tested hypothesis whether a strategy multivalent and sequential heterologous spike protein vaccinations would induce broader range higher levels neutralizing antibodies against more protection than homologous vaccination in mouse model. We determined spike-specific IgG, receptor-binding inhibition titers, protective efficacy groups mice that were vaccinated with recombinant proteins (Wuhan, Delta, Omicron), sequentially variants, or proteins. Trivalent (Wuhan + Delta Omicron) inducing serum activities receptor binding virus antibody titers vaccination. was observed trivalent after challenge mouse-adapted MA10 strain compared This study provides evidence variant might provide emerging significantly alleviate severe inflammation due

Язык: Английский

Процитировано

1
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 DOI Open Access
Nikolai Petrovsky

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

Процитировано

1
Effects of age and gender on immunogenicity and reactogenicity of SpikoGen recombinant spike protein vaccine: a post-hoc analysis DOI Creative Commons
Nassim Anjidani,

Ramin Shahpari,

Hamidreza Kafi

и другие.

Scientific Reports, Год журнала: 2024, Номер 14(1)

Опубликована: Сен. 30, 2024

Язык: Английский

Процитировано

1
Preparation of Bovine Coronavirus Virus-Like Particles and its Immunogenicity in Mice and Cattle DOI

Qisheng Yu,

Qing Zhu,

Xiangyue Huang

и другие.

Опубликована: Янв. 1, 2024

Язык: Английский

Процитировано

0