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PRE-CLINICAL IMMUNE RESPONSE AND SAFETY EVALUATION OF THE PROTEIN SUBUNIT VACCINE NANOCOVAX FOR COVID-19

Tran Thi Nhu Mai, Bruce May, Ung Trong Thuan, Nguyen Mai Khoi, Nguyen Thi Thuy Trang, Dinh Van Long, Doan Chinh Chung, Tran The Vinh, Khong Hiep, Nguyen Thi Thanh Truc, Hua Hoang Quoc Huy, Nguyen Viet Anh, Ha Tan Phat, Phan Dang Luu, Nguyen Truong An, Bui Thi Ngoc, Tu Tieu My, Nguyen Thi Theo, Le Thi Thuy Hang, Dong Thi Lan, Huynh Trong Hieu, Ho Phien Huong, Le Nguyen Thanh Thao, Truong Cong Thao, Pham Hoang Phi, Y Luong Cong, Nie Lim, Cao Minh Ngoc, Nguyen Duy Khanh, Trinh Thanh Hung, Do Minh Si
doi: https://doi.org/10.1101/2021.07.20.453162
Tran Thi Nhu Mai
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Bruce May
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Ung Trong Thuan
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Mai Khoi
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Thi Thuy Trang
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Dinh Van Long
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Doan Chinh Chung
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Tran The Vinh
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Khong Hiep
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Thi Thanh Truc
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Hua Hoang Quoc Huy
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Viet Anh
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Ha Tan Phat
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Phan Dang Luu
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Truong An
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Bui Thi Ngoc
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Tu Tieu My
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Thi Theo
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Le Thi Thuy Hang
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Dong Thi Lan
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Huynh Trong Hieu
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Ho Phien Huong
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Le Nguyen Thanh Thao
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Truong Cong Thao
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Pham Hoang Phi
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Y Luong Cong
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nie Lim
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Cao Minh Ngoc
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Nguyen Duy Khanh
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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Trinh Thanh Hung
2Ministry of Science and Technology, Hanoi, Vietnam
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Do Minh Si
1Nanogen Biopharmaceuticals JSc, Lot I-5C Saigon Hitech Park, Ho Chi Minh city, Vietnam
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  • For correspondence: minhsi@nanogenpharma.com
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Abstract

The Coronavirus disease-2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), has become a dire global health concern. The development of vaccines with high immunogenicity and safety is crucial for control of the global COVID-19 pandemic and prevention of further illness and fatalities. Here, we report development of SARS-CoV-2 vaccine candidate, Nanocovax, based on recombinant protein production of the extracellular (soluble) portion of the S protein of SARS-CoV-2. The results showed that Nanocovax induced high levels of S protein-specific IgG, as well neutralizing antibody in three animal models including Balb/C mice, Syrian hamsters, and non-human primate (Macaca leonina). In addition, the viral challenge study using the hamster model showed that Nanocovax protected the upper respiratory tract from SARS-CoV-2 infection. No adverse effects were induced by Nanocovax in swiss mice (Musmusculus var. Albino), Rats (Rattus norvegicus), and New Zealand rabbits. These pre-clinical results indicated that Nanocovax is safe and effective.

Competing Interest Statement

The authors have declared no competing interest.

Footnotes

  • ↵# These authors share first authorship

  • Abbreviations

    COVID-19
    Coronavirus disease-2019
    SARS-CoV-2
    Severe Acute Respiratory Syndrome coronavirus 2
    RBD
    receptor-binding domain
    ACE-2
    angiotensin-converting enzyme 2
    CHO
    Chinese hamster ovary
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    PRE-CLINICAL IMMUNE RESPONSE AND SAFETY EVALUATION OF THE PROTEIN SUBUNIT VACCINE NANOCOVAX FOR COVID-19
    Tran Thi Nhu Mai, Bruce May, Ung Trong Thuan, Nguyen Mai Khoi, Nguyen Thi Thuy Trang, Dinh Van Long, Doan Chinh Chung, Tran The Vinh, Khong Hiep, Nguyen Thi Thanh Truc, Hua Hoang Quoc Huy, Nguyen Viet Anh, Ha Tan Phat, Phan Dang Luu, Nguyen Truong An, Bui Thi Ngoc, Tu Tieu My, Nguyen Thi Theo, Le Thi Thuy Hang, Dong Thi Lan, Huynh Trong Hieu, Ho Phien Huong, Le Nguyen Thanh Thao, Truong Cong Thao, Pham Hoang Phi, Y Luong Cong, Nie Lim, Cao Minh Ngoc, Nguyen Duy Khanh, Trinh Thanh Hung, Do Minh Si
    bioRxiv 2021.07.20.453162; doi: https://doi.org/10.1101/2021.07.20.453162
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    PRE-CLINICAL IMMUNE RESPONSE AND SAFETY EVALUATION OF THE PROTEIN SUBUNIT VACCINE NANOCOVAX FOR COVID-19
    Tran Thi Nhu Mai, Bruce May, Ung Trong Thuan, Nguyen Mai Khoi, Nguyen Thi Thuy Trang, Dinh Van Long, Doan Chinh Chung, Tran The Vinh, Khong Hiep, Nguyen Thi Thanh Truc, Hua Hoang Quoc Huy, Nguyen Viet Anh, Ha Tan Phat, Phan Dang Luu, Nguyen Truong An, Bui Thi Ngoc, Tu Tieu My, Nguyen Thi Theo, Le Thi Thuy Hang, Dong Thi Lan, Huynh Trong Hieu, Ho Phien Huong, Le Nguyen Thanh Thao, Truong Cong Thao, Pham Hoang Phi, Y Luong Cong, Nie Lim, Cao Minh Ngoc, Nguyen Duy Khanh, Trinh Thanh Hung, Do Minh Si
    bioRxiv 2021.07.20.453162; doi: https://doi.org/10.1101/2021.07.20.453162

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