ABDALA, a preventive vaccine against SARS-CoV-2, is safe in Chlorocebus aethiops sabaeus monkeys

<p>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 Pi...

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Main Authors: Lizet Aldana (Author), Iliana Sosa (Author), Juan Carlos Polo (Author), Mariby Gutierrez (Author), Viviana Falcón (Author), Avelina León (Author), Rebeca Castillo (Author), Pedro Puente (Author), Nancy Esteves (Author), Rodolfo Valdés (Author), Marta Ayala (Author), Miladys Limonta (Author), Gerardo Guillén (Author), Jorge Castro Velazco (Author)
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Published: Advances in Toxicology and Toxic Effects - Peertechz Publications, 2023-10-26.
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001 peertech__10_17352_atte_000014
042 |a dc 
100 1 0 |a Lizet Aldana  |e author 
700 1 0 |a  Iliana Sosa  |e author 
700 1 0 |a  Juan Carlos Polo  |e author 
700 1 0 |a  Mariby Gutierrez  |e author 
700 1 0 |a  Viviana Falcón  |e author 
700 1 0 |a  Avelina León  |e author 
700 1 0 |a  Rebeca Castillo  |e author 
700 1 0 |a  Pedro Puente  |e author 
700 1 0 |a  Nancy Esteves  |e author 
700 1 0 |a  Rodolfo Valdés  |e author 
700 1 0 |a  Marta Ayala  |e author 
700 1 0 |a  Miladys Limonta  |e author 
700 1 0 |a  Gerardo Guillén  |e author 
700 1 0 |a Jorge Castro Velazco  |e author 
245 0 0 |a ABDALA, a preventive vaccine against SARS-CoV-2, is safe in Chlorocebus aethiops sabaeus monkeys 
260 |b Advances in Toxicology and Toxic Effects - Peertechz Publications,   |c 2023-10-26. 
520 |a <p>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. </p><p>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. </p><p>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.</p> 
540 |a Copyright © Lizet Aldana et al. 
546 |a en 
655 7 |a Research Article  |2 local 
856 4 1 |u https://doi.org/10.17352/atte.000014  |z Connect to this object online.