a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older.

The purpose of this study is to evaluate the safety, immunogenicity, and efficacy of Nanocovax vaccine in volunteer subjects 18 years of age and older.

Start Date07 Jun 2021

Sponsor / Collaborator

Nanogen Pharmaceutical Biotechnology JSC

NCT04683484 / Unknown statusPhase 1/2

Clinical Trials of Phase 1, 2 of Nanocovax Manufactured by Nanogen

The purpose of this study is to assess the safety, tolerability, and immunization of Nanocovax in healthy volunteers.

Start Date10 Dec 2020

Sponsor / Collaborator

Nanogen Pharmaceutical Biotechnology JSC

100 Clinical Results associated with Nanocovax

100 Translational Medicine associated with Nanocovax

100 Patents (Medical) associated with Nanocovax

Literatures (Medical) associated with Nanocovax

01 Jul 2022·The Lancet Regional Health - Western Pacific

Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial

Article

Author: Nguyen, Khanh D ; Huynh, Hieu T ; Tran, Hieu B ; Nguyen, Ngoc M ; Le, Giang Q ; Nguyen, Quan H ; Tran, Phong M ; Nguyen, Xuan T ; Pham, Dung T ; Dinh, Thanh T ; Vu, Thao T ; Trang, Tuyen N T ; Pham, Hung N ; Tran, Tien V ; Le, Tri M ; Pham, Quang D ; Khong, Hiep ; Nguyen, Quynh B P ; Hoang, Luong V ; Thuan, Ung T ; Tran, Vinh T ; Doan, Uyen Y ; Nguyen, Hang L K ; Ho, Son A ; Nguyen, Truc T T ; Chu, Men V ; Nguyen, Thuong V ; Nguyen, Linh T ; Nguyen, Viet T ; Phan, Vuong T ; Nguyen, Thuy P ; Do, Si M ; Vo, Thuong V ; Ha, Phat T ; Tran, Tuynh Q ; Nguyen, Giang T ; Nguyen, Dung D ; Phan, Lan T ; Nguyen, Tien G ; Doan, Chung C ; Nghiem, Thuan D ; Do, Quyet ; Hoang, Su X ; Tran, Mai T N ; Tran, Linh P ; Do, Anh T ; Dinh, Duc V ; Cao, Thang M ; Nguyen, Toan T ; Dao, Huy M ; Le, Vy T T ; Nguyen, Ngoc T ; Nguyen, Hieu T ; Nguyen, Thao T T ; Nguyen, Luong V ; Vu, Son T ; Tran, Ton ; Pham, Hang T T ; Do, Trung M

BackgroundNanocovax is a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length prefusion stabilized recombinant SARS-CoV-2 spike glycoproteins (S-2P) and aluminium hydroxide adjuvant.MethodsWe conducted a dose-escalation, open label trial (phase 1) and a randomized, double-blind, placebo-controlled trial (phase 2) to evaluate the safety and immunogenicity of the Nanocovax vaccine (in 25 mcg, 50 mcg, and 75 mcg doses, aluminium hydroxide adjuvanted (0·5 mg/dose) in 2-dose regime, 28 days apart (ClinicalTrials.gov number, NCT04683484). In phase 1, 60 participants received two intramuscular injection of the vaccine following dose-escalation procedure. The primary outcomes were reactogenicity and laboratory tests to evaluate the vaccine safety. In phase 2, 560 healthy adults received either vaccine doses similar in phase 1 (25 or 50 or 75 mcg S antigen in 0·5 mg aluminium per dose) or adjuvant (0·5 mg aluminium) in a ratio of 2:2:2:1. One primary outcome was the vaccine safety, including solicited adverse events for 7 day and unsolicited adverse events for 28 days after each injection as well as serious adverse event or adverse events of special interest throughout the study period. Another primary outcome was anti-S IgG antibody response (Index unit/ml). Secondary outcomes were surrogate virus neutralisation (inhibition percentage), wild-type SARS-CoV-2 neutralisation (dilution fold), and T-cell responses by intracellular staining for interferon gamma (IFNg). Anti-S IgG and neutralising antibody levels were compared with convalescent serum samples from symptomatic Covid-19 patients.FindingsFor phase 1 study, no serious adverse events were observed for all 60 participants. Most adverse events were grade 1 and disappeared shortly after injection. For phase 2 study, after randomisation, 480 participants were assigned to receive the vaccine with adjuvant, and 80 participants were assigned to receive the placebo (adjuvant only). Reactogenicity was absent or mild in the majority of participants and of short duration (mean ≤3 days). Unsolicited adverse events were mild in most participants. There were no serious adverse events related to Nanocovax. Regarding the immunogenicity, Nanocovax induced robust anti-S antibody responses. In general, there humoral responses were similar among vaccine groups which reached their peaks at day 42 and declined afterward. At day 42, IgG levels of vaccine groups were 60·48 [CI95%: 51·12-71·55], 49·11 [41·26-58·46], 57·18 [48·4-67·5] compared to 7·10 [6·32-13·92] of convalescent samples. IgG levels reported here can be converted to WHO international standard binding antibody unit (BAU/ml) by multiplying them to a conversion factor of 21·8. Neutralising antibody titre of vaccine groups at day 42 were 89·2 [52·2-152·3], 80·0 [50·8-125.9] and 95·1 [63·1-143·6], compared to 55·1 [33·4-91·0] of the convalescent group.InterpretationUp to day 90, Nanocovax was found to be safe, well tolerated, and induced robust immune responses.FundingThis work was funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the Ministry of Science and Technology of Vietnam, and Nanogen Pharmaceutical Biotechnology JSC.

Frontiers in Immunology

Preclinical Immune Response and Safety Evaluation of the Protein Subunit Vaccine Nanocovax for COVID-19

Article

Author: Tran, The Vinh ; Nguyen, Mai Khoi ; Le, Thi Thanh ; Truong, Cong Thao ; Do, Minh Si ; Ha, Tan Phat ; Le, Nguyen Thanh Thao ; Ung, Trong Thuan ; Khong, Hiep ; Nguyen, Thi Thuy Trang ; Nguyen, Le Khanh Hang ; Nguyen, Duy Khanh ; Dinh, Van Long ; Hua, Hoang Quoc Huy ; Ho, Phien Huong ; Nguyen, Thi Thanh Truc ; Nguyen, Truong An ; Cao, Minh Ngoc ; Y, Nie Lim ; Le, Thi Thuy Hang ; Doan, Chinh Chung ; Tran, Thi Nhu Mai ; Nguyen, Thi Theo ; Phan, Dang Luu ; Tu, Tieu My ; May, Bruce Pearson ; Huynh, Trong Hieu ; Nguyen, Viet Anh ; Luong, Cong Y ; Vuong, Duc Cuong ; Dong, Thi Lan ; Pham, Hoang Phi ; Bui, Thi Ngoc

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a global health concern. The development of vaccines with high immunogenicity and safety is crucial for controlling the global COVID-19 pandemic and preventing further illness and fatalities. Here, we report the development of a SARS-CoV-2 vaccine candidate, Nanocovax, based on recombinant protein production of the extracellular (soluble) portion of the spike (S) protein of SARS-CoV-2. The results showed that Nanocovax induced high levels of S protein-specific IgG and neutralizing antibodies in three animal models: BALB/c mouse, Syrian hamster, and a non-human primate (Macaca leonina). In addition, a viral challenge study using the hamster model showed that Nanocovax protected the upper respiratory tract from SARS-CoV-2 infection. Nanocovax did not induce any adverse effects in mice (Mus musculus var. albino) and rats (Rattus norvegicus). These preclinical results indicate that Nanocovax is safe and effective.

100 Deals associated with Nanocovax

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	VN	Nanogen Pharmaceutical Biotechnology JSC	07 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04683484 (Pubmed) Manual	Phase 1/2	COVID-19 First line	620	aluminium hydroxide adjuvanted+Nanocovax vaccine (For phase 1 study)	(thdhkhxbij) = nsalzgyoti shwjdrnpfn (abzxtyitde )	Positive	16 May 2022
				aluminium hydroxide adjuvanted+Nanocovax vaccine (For phase 2 study)	(itkiucpmwz) = refkfodnnh keyiqimofh (ywnwyjljqv )

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