ABDALA是一种针对SARS-CoV-2的预防性疫苗,在沙猴身上是安全的

Aldana Lizet, Sosa Iliana, Polo Juan Carlos, Gutierrez Mariby, Falcón Viviana, León Avelina, Castillo Rebeca, Puente Pedro, Esteves Nancy, Valdés Rodolfo, Ayala Marta, Limonta Miladys, Guillén Gerardo, Velazco Jorge Castro
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摘要

背景:ABDALA疫苗是一种亚单位疫苗,用于预防SARS-CoV-2感染和COVID-19向严重形式的进展,使用毕氏酵母中表达的SARS-CoV-2刺突蛋白受体结合域(RBD)的重组版本作为活性药物成分。本文的目的是描述ABDALA疫苗在猴子(Cholorocebus aethiops sabaeus)中的安全性。为了实现这一目标,按照与针对COVID-19的临床试验相同的方案,每14天对猴子进行6次肌肉注射疫苗。动物被分为四组:安慰剂组、ABDALA低剂量组(每只动物50µg)、ABDALA高剂量组(每只动物100µg)和逆转组(每只动物100µg),进行临床、血液学和血清生化评估。并对各组织器官进行组织病理学检查。结果:动物临床评价中,主要结果是所有动物均存活,未发现不良反应。体重和直肠温度没有变化,血液学和血清生化参数没有显示与ABDALA相关的改变。最后,组织病理学研究证实了ABDALA引起的脾白髓增生。结论:因此,研究结果强烈提示ABDALA不会对绿尾猴的器官造成毒性作用或损害,表明它是一种有希望和安全的新型疫苗,可以预防人类感染SARS-CoV-2和COVID-19向严重形式的发展。
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ABDALA, a preventive vaccine against SARS-CoV-2, is safe in Chlorocebus aethiops sabaeus monkeys
Background: The ABDALA vaccine is a subunit vaccine developed for preventing SARS-CoV-2 infection and the progression of COVID-19 to severe forms, using as an active pharmaceutical ingredient a recombinant version of the SARS-CoV-2 spike protein receptor-binding domain (RBD) expressed in Pichia pastoris. The aim of the paper was to describe the safety profile of the ABDALA vaccine in monkeys (Cholorocebus aethiops sabaeus). For such aim, the vaccine was administered to the monkeys intramuscularly six times every 14 days, following the same scheme used in clinical trials done against COVID-19. Animals were allocated to four groups: Placebo, ABDALA Low-dose (50 µg per animal), ABDALA High-dose (100 µg per animal), and Reversion (100 µg per animal) to be submitted to a clinical, hematological and serum biochemical evaluation. Histopathological assessment of all tissues and organs was also conducted. Results: As the main results, all animals survived and negative effects were not detected during animal clinical evaluations. The body weight and rectal temperature exhibited no variations and hematological and serum biochemical parameters showed no alterations associated with ABDALA administration. Finally, the histopathological study confirmed the proliferation of spleen white pulp due to ABDALA administration. Conclusions: Therefore, results strongly suggest ABDALA does not cause toxic effects or damage in the organs of Chlorocebus aethiops sabaeus monkeys, indicating that it is a promising and safe novel vaccine to prevent SARS-CoV-2 infection in humans and the progression of COVID-19 to severe forms.
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