Thuy p Nguyen 1 ,Quyet vày 2 ,Lan T Phan 3 ,Duc V Dinh 2 ,Hiep Khong 1 ,Luong V Hoang 2 ,Thuong V Nguyen 3 ,Hung N Pham 2 ,Men V Chu 2 ,Toan T Nguyen 3 ,Quang D Pham 3 ,Tri M Le 1 ,Tuyen N T Trang 1 ,Thanh T Dinh 1 ,Thuong V Vo 1 ,Thao T Vu 1 ,Quynh B p Nguyen 1 ,Vuong T Phan 1 ,Luong V Nguyen 2 ,Giang T Nguyen 2 ,Phong M Tran 2 ,Thuan D Nghiem 2 ,Tien V Tran 2 ,Tien G Nguyen 2 ,Tuynh Q Tran 2 ,Linh T Nguyen 2 ,Anh T vị 2 ,Dung D Nguyen 2 ,Son A Ho 2 ,Viet T Nguyen 2 ,Dung T Pham 2 ,Hieu B Tran 2 ,Son T Vu 2 ,Su X Hoang 2 ,Trung M bởi vì 2 ,Xuan T Nguyen 2 ,Giang Q Le 2 ,Ton Tran 3 ,Thang M Cao 3 ,Huy M Dao 3 ,Thao T T Nguyen 3 ,Uyen Y Doan 3 ,Vy T T Le 3 ,Linh p Tran 3 ,Ngoc M Nguyen 3 ,Ngoc T Nguyen 3 ,Hang T T Pham 3 ,Quan H Nguyen 3 ,Hieu T Nguyen 3 ,Hang L K Nguyen 4 ,Vinh T Tran 1 ,Mai T N Tran 1 ,Truc T T Nguyen 1 ,Phat T Ha 1 ,Hieu T Huynh 1 ,Khanh D Nguyen 1 ,Ung T Thuan 1 ,Chung C Doan 1 ,Si M do 1


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Affiliations

1 Nanogen Pharmaceutical Biotechnology JSC, Lot I-5C Saigon Hitech Park, Ho đưa ra Minh City, Viet Nam. 2 Vietnam Military Medical University, 160 Phung Hung, Ha Dong, Ha Noi, Viet Nam. 3 Pasteur Institute, 167 Pasteur, District 3, Ho chi Minh City, Viet Nam. 4 National Institute of Hygiene & Epidemiology (NIHE), Ha Noi, Viet Nam.
PMID: 35602004 free PMC article
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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
Thuy p. Nguyenet al. Lancet Reg Health West Pac. 2022.
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Lancet Reg Health West Pac
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. 2022 May 16;24:100474.
doi: 10.1016/j.lanwpc.2022.100474. eCollection 2022 Jul.

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Thuy p Nguyen 1 ,Quyet bởi vì 2 ,Lan T Phan 3 ,Duc V Dinh 2 ,Hiep Khong 1 ,Luong V Hoang 2 ,Thuong V Nguyen 3 ,Hung N Pham 2 ,Men V Chu 2 ,Toan T Nguyen 3 ,Quang D Pham 3 ,Tri M Le 1 ,Tuyen N T Trang 1 ,Thanh T Dinh 1 ,Thuong V Vo 1 ,Thao T Vu 1 ,Quynh B p. Nguyen 1 ,Vuong T Phan 1 ,Luong V Nguyen 2 ,Giang T Nguyen 2 ,Phong M Tran 2 ,Thuan D Nghiem 2 ,Tien V Tran 2 ,Tien G Nguyen 2 ,Tuynh Q Tran 2 ,Linh T Nguyen 2 ,Anh T bởi 2 ,Dung D Nguyen 2 ,Son A Ho 2 ,Viet T Nguyen 2 ,Dung T Pham 2 ,Hieu B Tran 2 ,Son T Vu 2 ,Su X Hoang 2 ,Trung M do 2 ,Xuan T Nguyen 2 ,Giang Q Le 2 ,Ton Tran 3 ,Thang M Cao 3 ,Huy M Dao 3 ,Thao T T Nguyen 3 ,Uyen Y Doan 3 ,Vy T T Le 3 ,Linh phường Tran 3 ,Ngoc M Nguyen 3 ,Ngoc T Nguyen 3 ,Hang T T Pham 3 ,Quan H Nguyen 3 ,Hieu T Nguyen 3 ,Hang L K Nguyen 4 ,Vinh T Tran 1 ,Mai T N Tran 1 ,Truc T T Nguyen 1 ,Phat T Ha 1 ,Hieu T Huynh 1 ,Khanh D Nguyen 1 ,Ung T Thuan 1 ,Chung C Doan 1 ,Si M do một

Affiliations

1 Nanogen Pharmaceutical Biotechnology JSC, Lot I-5C Saigon Hitech Park, Ho đưa ra Minh City, Viet Nam. 2 Vietnam Military Medical University, 160 Phung Hung, Ha Dong, Ha Noi, Viet Nam. 3 Pasteur Institute, 167 Pasteur, District 3, Ho đưa ra Minh City, Viet Nam. 4 National Institute of Hygiene and Epidemiology (NIHE), Ha Noi, Viet Nam.
PMID: 35602004
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Abstract


Background: Nanocovax 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) và aluminium hydroxide adjuvant.

Methods: We conducted a dose-escalation, open label trial (phase 1) and a randomized, double-blind, placebo-controlled trial (phase 2) to lớn evaluate the safety và immunogenicity of the Nanocovax vaccine (in 25 mcg, 50 mcg, & 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 và laboratory tests lớn 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 và unsolicited adverse events for 28 days after each injection as well as serious adverse sự kiện 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.

Findings: For phase 1 study, no serious adverse events were observed for all 60 participants. Most adverse events were grade 1 & disappeared shortly after injection. For phase 2 study, after randomisation, 480 participants were assigned khổng lồ receive the vaccine with adjuvant, & 80 participants were assigned to lớn 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 lớn 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 & declined afterward. At day 42, IgG levels of vaccine groups were 60·48 , 49·11 <41·26-58·46>, 57·18 <48·4-67·5> compared khổng lồ 7·10 <6·32-13·92> of convalescent samples. IgG levels reported here can be converted lớn WHO international standard binding antibody unit (BAU/ml) by multiplying them khổng lồ 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> & 95·1 <63·1-143·6>, compared khổng lồ 55·1 <33·4-91·0> of the convalescent group.

Interpretation: Up to day 90, Nanocovax was found lớn be safe, well tolerated, & induced robust immune responses.

Funding: This work was funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the Ministry of Science & Technology of Vietnam, & Nanogen Pharmaceutical Biotechnology JSC.




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Keywords: Immunogenicity; Phase 1 & 2 clinical trial; Protein sub-unit vaccine; SARS-CoV-2; Spike protein.


TPN, HK, TML, TTNT, TTD, TVV, TTTV, QBPN, VTP, VTT, MTNT, TTTN, PTH, HTH, KDN, CCD, TTU, SMD are employees of Nanogen Pharmaceutical Biotechnology JSC. MTNT, & SMD are authors of a pending patent for Nanocovax.