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, Journal Year: 2024, Volume and Issue: 25(17), P. 9459 - 9459

Published: Aug. 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

Language: Английский

Immunogenicity in mice and non-human primates of an Advax-CpG55.2-adjuvanted recombinant hemagglutinin seasonal quadrivalent influenza vaccine DOI
Yoshikazu Honda‐Okubo,

Utsav Vaghasiya,

Nikolai Petrovsky

et al.

Vaccine, Journal Year: 2025, Volume and Issue: 47, P. 126707 - 126707

Published: Jan. 10, 2025

Language: Английский

Citations

0
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

et al.

Vaccine, Journal Year: 2025, Volume and Issue: 49, P. 126744 - 126744

Published: Feb. 5, 2025

Language: Английский

Citations

0
Insect-specific virus platforms for arbovirus vaccine development DOI Creative Commons
Roy A. Hall, Wilson Nguyen, Alexander A. Khromykh

et al.

Frontiers in Immunology, Journal Year: 2025, Volume and Issue: 16

Published: March 14, 2025

Certain insect-specific viruses (ISVs), specifically the mosquito alphaviruses, Eilat and Yada viruses, orthoflaviviruses, Binjari, Aripo, YN15-283-02 Chaoyang have emerged as potential platforms for generation of whole virus vaccines human veterinary applications. These ISVs are remarkably tolerant substitution their structural polyproteins with those alphaviruses orthoflaviviruses that pathogenic in humans and/or animals. The resulting ISV-based chimeric been evaluated mouse models demonstrated safety efficacy non-human primates, crocodiles pigs. Targets include chikungunya, Venezuelan eastern equine encephalitis, dengue, Zika, yellow fever, Japanese encephalitis West Nile viruses. provide authentically folded tertiary quaternary virion particle structures to immune system, a key feature induction protective antibody responses. manufactured C6/36 or C7-10 cell lines, where they grow high titers, but do not replicate vertebrate vaccine recipients. This review discusses progress these emerging technologies addresses challenges related adjuvanting, safety, manufacturing.

Language: Английский

Citations

0
Enhanced Humoral and Cellular Immune Responses Elicited by Salmonella Flagellin-Adjuvanted SARS-CoV-2 S1 Subunit Vaccine DOI
Song Li,

Yaodan Cui,

Qiaoju Wang

et al.

Viral Immunology, Journal Year: 2025, Volume and Issue: unknown

Published: March 24, 2025

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, has been spreading and changing globally. Adjuvant-based vaccines can improve vaccine protection by enhancing immune response. Bacterial flagellin is a potent adjuvant promotes protective responses. Here, we successfully expressed purified S1 subunit of SARS-CoV-2. The adjuvanticity (FliC) Salmonella Typhimurium in mice was determined combining it with recombinant vaccine. FliC-adjuvanted could induce significantly enhanced S1-specific Immunoglobulin G (IgG), IgG1 IgG2a titers, SARS-CoV-2-neutralizing antibodies, levels Th1 type (TNF-α IFN-γ) Th2 (Interleukin-5 (IL-5), IL-4, IL-10, IL-13) cytokines splenocytes compared alone group. Additionally, titers IgG antibodies FliC group maintain high level for at least months. These results indicated trigger strong humoral cellular responses, which promote ongoing development COVID-19 vaccines.

Language: Английский

Citations

0
Advax®-adjuvanted inactivated influenza vaccine provides accelerated protection of mice via early induction of an influenza-specific IgM response DOI
Yoshikazu Honda‐Okubo, Isaac G. Sakala, Lei Li

et al.

Vaccine, Journal Year: 2025, Volume and Issue: 56, P. 127144 - 127144

Published: April 23, 2025

Language: Английский

Citations

0
Progress and prospect of polysaccharides as adjuvants in vaccine development DOI Creative Commons
Xiaoping Liang, Jianshe Zhou, Mengmeng Wang

et al.

Virulence, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 27, 2024

Vaccines are an effective approach to confer immunity against infectious diseases. Modern subunit vaccines offer more precise target and safe protection compared traditional whole-pathogen vaccines. However, require adjuvants stimulate the immune system due less immunogenicity. Adjuvants strengthen immunogenicity by enhancing, modulating, prolonging response. Unfortunately, few have sufficient potency low enough toxicity for clinical use, highlighting urgent need new vaccine with characteristics of safety, efficacy, cost-effectiveness. Notably, some natural polysaccharides been approved as in human vaccines, owing their intrinsic immunomodulation, toxicity, high safety. Natural mainly derived from plants, bacteria, yeast. Partly difficulty obtaining them, synthetic emerged trials. The mechanisms both remain incompletely understood, hindering rational development polysaccharide adjuvants. This comprehensive review primarily focused on several promising adjuvants, discussing recent applications immune-modulatory effects. Furthermore, future perspectives insightful guidance adjuvant application.

Language: Английский

Citations

3
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, Journal Year: 2024, Volume and Issue: 25(17), P. 9459 - 9459

Published: Aug. 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

Language: Английский

Citations

1