单剂量SpikoGen®疫苗作为异源或同源肌肉注射加强针，在门诊成人中于mRNA、腺病毒载体或重组蛋白COVID-19疫苗初免后进行的免疫原性和安全性研究。
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.
作者信息
Honda-Okubo Yoshikazu, Sajkov Dimitar, Wauchope Bruce, Turner Joseph V, Vote Brendan, Antipov Anna, André Greiciely, Lebedin Yuri, Petrovsky Nikolai
机构信息
Vaxine Pty Ltd, Warradale, Adelaide, SA 5046, Australia; Australian Respiratory and Sleep Medicine Institute Ltd, Adelaide, SA 5042, Australia.
Australian Respiratory and Sleep Medicine Institute Ltd, Adelaide, SA 5042, Australia.
出版信息
Vaccine. 2025 Mar 7;49:126744. doi: 10.1016/j.vaccine.2025.126744. Epub 2025 Feb 5.
BACKGROUND
SpikoGen® is a subunit recombinant Wuhan spike protein produced in insect cells and formulated with Advax-CpG55.2™ adjuvant. It is approved for adult and pediatric use in the Middle East. This study tested the safety and immunogenicity of SpikoGen® as a 3rd, 4th or 5th dose booster following a primary immunisation course of mRNA, adenovirus or SpikoGen® 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® 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 ∼4-fold neutralizing antibodies against the heterologous Omicron BA.2 and BA.4/5 strains. The SpikoGen®-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® 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.
CLINICALTRIALS
gov registration. NCT05542862.
背景
SpikoGen®是一种在昆虫细胞中产生的亚单位重组武汉刺突蛋白，并与Advax-CpG55.2™佐剂配制而成。它已在中东地区获批用于成人和儿童。本研究测试了SpikoGen®作为mRNA、腺病毒或SpikoGen®疫苗初次免疫疗程后的第三、第四或第五剂加强针的安全性和免疫原性。
方法
该试验招募了在3个多月前曾接种过一剂新冠疫苗的参与者。每人接受一剂SpikoGen®疫苗的肌肉注射加强针。在加强针接种后1个月和3个月测量刺突蛋白和核蛋白抗体水平，并收集有关SARS-CoV-2突破性感染和长期新冠症状的数据。
结果
加强针接种后1个月，所有组的抗刺突IgG、sVNT和pVNT水平均升高，并且针对异源奥密克戎BA.2和BA.4/5毒株有~4倍的中和抗体。SpikoGen®初免组的抗刺突IgG3水平最高，这与Advax-CpG佐剂驱动IgG3诱导一致。年龄对疫苗反应没有影响。加强针耐受性良好，没有与疫苗相关的严重不良事件。9名参与者（9/74，12.2%）在加强针接种后2周和3个月之间出现了突破性SARS-CoV-2感染。突破性感染后未观察到长期新冠。突破性感染与基线抗核蛋白IgG血清阳性呈负相关。
结论
无论之前接受的初次疫苗疗程如何，一剂SpikoGen®加强针耐受性良好，并刺激了针对奥密克戎变体的交叉抗体反应。随着SARS-CoV-2变体不断演变，需要持续研究最佳加强针策略。
临床试验
美国国立医学图书馆临床试验注册库登记号。NCT05542862。
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