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

被引：0
作者：
Honda-Okubo, Yoshikazu [1 ,2 ]
Sajkov, Dimitar [2 ]
Wauchope, Bruce [3 ]
Turner, Joseph V. [4 ]
Vote, Brendan [5 ]
Antipov, Anna [1 ]
Andre, Greiciely [1 ,2 ]
Lebedin, Yuri
Petrovsky, Nikolai [1 ,2 ]
机构：
[1] Vaxine Pty Ltd, Adelaide, SA 5046, Australia
[2] Australian Resp & Sleep Med Inst Ltd, Adelaide, SA 5042, Australia
[3] Bedford Clin, South Rd, Adelaide, SA 5039, Australia
[4] Univ New England, Sch Rural Med, Armidale, NSW 2351, Australia
[5] Tasmanian Eye Inst Ltd, Launceston, Tas 7250, Australia
来源：
VACCINE | 2025年 / 49卷
基金：
美国国家卫生研究院;
关键词：
COVID-19; SARS-CoV-2; Vaccine; Pandemic; Adjuvant; Advax-CpG; Delta inulin; SARS-COV-2 SPIKE PROTEIN; INFECTION;
D O I：
10.1016/j.vaccine.2025.126744
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
Background: SpikoGen (R) is a subunit recombinant Wuhan spike protein produced in insect cells and formulated with Advax-CpG55.2 (TM) adjuvant. It is approved for adult and pediatric use in the Middle East. This study tested the safety and immunogenicity of SpikoGen (R) as a 3rd, 4th or 5th dose booster following a primary immunisation course of mRNA, adenovirus or SpikoGen (R) vaccine. Methods: The trial recruited participants who had received a previous doses of COVID-19 vaccine more than 3 months prior. Each received a single intramuscular booster dose of SpikoGen (R) vaccine. Spike and nuclear protein antibody levels were measured at 1 and 3 months post-booster, together with collection of data on SARS-CoV-2 breakthrough infections and symptoms of long COVID. Results: One-month post-booster, anti-spike IgG, sVNT, and pVNT levels were increased in all groups and there was similar to 4-fold neutralizing antibodies against the heterologous Omicron BA.2 and BA.4/5 strains. The SpikoGen (R)-prime group had the highest levels of anti-spike IgG3, consistent with the Advax-CpG adjuvant driving IgG3 induction. There was no effect of age on the vaccine response. The booster dose was well tolerated with no vaccine-associated serious adverse events. Nine participants (9/74, 12.2 %) had a breakthrough SARS-CoV-2 infection between 2 weeks and 3 months post-booster. No long COVID was observed after breakthrough infections. Breakthrough infection was negatively correlated with baseline anti-nuclear protein IgG seropositivity. Conclusion: A single SpikoGen (R) booster was well tolerated and stimulated cross- antibody responses against Omicron variants, regardless of the primary vaccine course received. With SARS-CoV-2 variants continuing to evolve, ongoing research is needed into optimum booster strategies.
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页数：11
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