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Preclinical evaluation of a plant-derived SARS-CoV-2 subunit vaccine: Protective efficacy, immunogenicity, safety, and toxicity.
Shanmugaraj, Balamurugan; Khorattanakulchai, Narach; Panapitakkul, Chalisa; Malla, Ashwini; Im-Erbsin, Rawiwan; Inthawong, Manutsanun; Sunyakumthorn, Piyanate; Hunsawong, Taweewun; Klungthong, Chonticha; Reed, Matthew C; Kemthong, Taratorn; Suttisan, Nutchanat; Malaivijitnond, Suchinda; Srimangkornkaew, Passaraporn; Klinkhamhom, Aekkarin; Manopwisedjaroen, Suwimon; Thitithanyanont, Arunee; Taychakhoonavudh, Suthira; Phoolcharoen, Waranyoo.
  • Shanmugaraj B; Baiya Phytopharm Co., Ltd, Bangkok 10330, Thailand.
  • Khorattanakulchai N; Center of Excellence in Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand.
  • Panapitakkul C; Center of Excellence in Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand.
  • Malla A; Baiya Phytopharm Co., Ltd, Bangkok 10330, Thailand.
  • Im-Erbsin R; Department of Veterinary Medicine, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Inthawong M; Department of Veterinary Medicine, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Sunyakumthorn P; Department of Veterinary Medicine, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Hunsawong T; Department of Virology, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Klungthong C; Department of Virology, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Reed MC; Department of Veterinary Medicine, U.S. Army Medical Directorate-Armed Forces Research Institute of Medical Sciences, Bangkok 10400, Thailand.
  • Kemthong T; National Primate Research Center of Thailand-Chulalongkorn University, Saraburi 18110, Thailand.
  • Suttisan N; National Primate Research Center of Thailand-Chulalongkorn University, Saraburi 18110, Thailand.
  • Malaivijitnond S; National Primate Research Center of Thailand-Chulalongkorn University, Saraburi 18110, Thailand.
  • Srimangkornkaew P; National Laboratory Animal Center, Mahidol University, Nakorn Pathom 73170, Thailand.
  • Klinkhamhom A; National Laboratory Animal Center, Mahidol University, Nakorn Pathom 73170, Thailand.
  • Manopwisedjaroen S; Department of Microbiology, Faculty of Science, Mahidol University, Bangkok 10400, Thailand.
  • Thitithanyanont A; Department of Microbiology, Faculty of Science, Mahidol University, Bangkok 10400, Thailand.
  • Taychakhoonavudh S; Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand.
  • Phoolcharoen W; Center of Excellence in Plant-produced Pharmaceuticals, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmacognosy and Pharmaceutical Botany, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand. Electronic address: Waranyoo.P@chula.ac.th.
Vaccine ; 40(32): 4440-4452, 2022 07 30.
Article in English | MEDLINE | ID: covidwho-1882608
ABSTRACT
Coronavirus disease 2019 (COVID-19) is an acute respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The prevention of SARS-CoV-2 transmission has become a global priority. Previously, we showed that a protein subunit vaccine that was developed based on the fusion of the SARS-CoV-2 receptor-binding domain (RBD) to the Fc portion of human IgG1 (RBD-Fc), produced in Nicotiana benthamiana, and adjuvanted with alum, namely, Baiya SARS-CoV-2 Vax 1, induced potent immunological responses in both mice and cynomolgus monkeys. Hence, this study evaluated the protective efficacy, safety, and toxicity of Baiya SARS-CoV-2 Vax 1 in K18-hACE2 mice, monkeys and Wistar rats. Two doses of vaccine were administered three weeks apart on Days 0 and 21. The administration of the vaccine to K18-hACE2 mice reduced viral loads in the lungs and brains of the vaccinated animals and protected the mice against challenge with SARS-CoV-2. In monkeys, the results of safety pharmacology tests, general clinical observations, and a core battery of studies of three vital systems, namely, the central nervous, cardiovascular, and respiratory systems, did not reveal any safety concerns. The toxicology study of the vaccine in rats showed no vaccine-related pathological changes, and all the animals remained healthy under the conditions of this study. Furthermore, the vaccine did not cause any abnormal toxicity in rats and was clinically tolerated even at the highest tested concentration. In addition, general health status, body temperature, local toxicity at the administration site, hematology, and blood chemistry parameters were also monitored. Overall, this work presents the results of the first systematic study of the safety profile of a plant-derived vaccine, Baiya SARS-CoV-2 Vax 1; this approach can be considered a viable strategy for the development of vaccines against COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Systematic review/Meta Analysis Topics: Vaccines Limits: Animals Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.05.087

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Systematic review/Meta Analysis Topics: Vaccines Limits: Animals Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.05.087