Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
➤ Gửi thông báo lỗi ⚠️ Báo cáo tài liệu vi phạmNội dung chi tiết: Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine Due V. Dinh A/D2". Hiep Khong PhD™, Luong V. Hoang A/D PhD2. Thuong V. Nguyen A/D PhD3. Hung N. Pham A/D PhD*, A/en K Chu PharmD PhD2. Toan T. Nguyen A/D A/Sc3. Quang D. Pham A/D PhD3. Tri AL LeA/Sc1. TuyenN. T. Trang PharmD*. Thanh T. Dinh A/.SN. Thuong V. Vo B.PHL Thao T. Vu B.PH'. Quynh B.p. Nguy Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine en PharmD2. Vuong T. Phan PharmD1. Luong V. Nguyen A/D PhD2. Giang T. Nguyen A/D PhD2. Phong AL Tran A/D PhD Thuan D. Nghiem A/D PhD2. Tien V. Tran A/Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
D PhD2. Tien G. Nguyen A/D PhD2. Tuynh o. Tran A/D PhD2. Linh T. Nguyen A/D PhD2, Anh T. Do AID PhD2. Dung D. Nguyen A/D PhD2, Son .4. Ho A/D PhD2, ViSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine /D PhD2. Giang Q. Le PhD2, Ton Tran A/D PhD3. Thang AL Cao A/Sc3, Huy AL Dao PhD3. Thao T.T. Nguyen A/D3. Uyen Y Doan ALSc3, Vy T.T. Le PhD3. Linh p. Tran A/.Sc3, Ngoe AL Nguyen A/D3. Ngoe T. Nguyen AISc3, Hang T. T. Pham A/Sc3, Quan H Nguyen A/Sc3, Hieu T. Nguyen BSc3, Hang L.K. Nguyen PhD'. Vinh T Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine . Tran PhD1 ,A/ai T.N. Tran PhD'Ậ. True T.T. Nguyen A/Sc1, Phat T. Ha A/Sc1, Hieu T. Huynh BSc1. Khanh D. Nguyen BSc1, ưng T. Thuan3, Chung c. Doan PhSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
D1. Si A/. Do Ph.D1*Affiliations:1 Nanogen Pharmaceutical Biotechnology JSC, Lot I-5C Saigon Hitech Park, Ho Chi Minh city. Vietnam- Vietnam Military Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine te of Hygiene and Epidemiology (NIHE). Ha Noi. Vietnam’ These authors contiibuted equally to this article* Corresponding author: Do Minh Si, PhDNanogen Pharmaceutical Biotechnology JSC; Lot I-5C Saigon Hitech Park. Ho CI11 MinhCity. Vietnam: Phone: (+84)-93-846-3579. FAX: 84-283-730-9963; Email:minl Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine isi@iianogenphanna.comThis preprint research paper has not been pecDie copy available at https://ssm com/abstract=3931736SummaryBackgroundNanocovax isSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length piefusion stabilized recombinant SARS-CoV-2 spiSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine nd, placebo-controlled trial (phase 2) to evaluate the safety and inununogenicity of the Nanocovax vaccine (ill 25 microgram (mcg). 50 mcg. and 75 mcg doses, aluminum hydroxide adjuvanted). In phase 1. 60 participants received two intramuscular injection of the vaccine following doseescalation proce Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine dure. The primary outcomes were reactogenicity and laboratory' tests to evaluate the vaccine safety. In phase 2 which involved 111 560 healthy adults,Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
the primaryoutcomes are vaccine safety, and anti-S IgG antibody response. Secondary outcomes were surrogate virus neutralization, wild-type SARS-CoV-Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine ompared with convalescent serum samples from symptomatic Covid-19 patients. FindingsFor phase 1 study, no serious adverse events (SAE) were observed for all 60 participants. Most adverse events (AE) were grade 1 and disappeared shortly after injection. For phase 2 study, after randomization. 480 par Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine ticipants were assigned to receive the vaccine with adjuvant, and 80 participants were assigned to receive placebo. Reactogenicity was absent or mildSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
in the majority of participants and of short duration (mean <3 days). Unsolicited adverse events were mild in most participants. There were no seriousSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine onses were similar among vaccine groups up to day 90 Anti S-IgG levels and neutralizing antibody titers at the peak response on day 42 were all higher than those of convalescent sera.InterpretationUp to day 90. Nanocovax was found to be safe, well tolerated, and induced robust immune responses. 25 m Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine cg was selected for a phase 3 trial to evaluate the vaccine efficacy.FundingResearch funded by Nanogen Pharmaceutical Biotechnology JSC., and the MiniSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
stry of Science and Technology of Vietnam; ClimcalTrials.gov number. NCT04683484.This preprint research paper has not been peer reviewed. Electronic cSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine ratory syndrome coronavirus 2 (SARS-CoV-2). As of July 2021. more than 177 million cases and over 4 million deaths due to Covid-19 have been reported worldwide1.SARS-CoV-2 is a member betacoronavirus. named for Its corona of spike (S) proteins protruding from the viral envelope-1 SARS-CoV-2 s. a hea Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine vily glycosylated protein, is responsible for the attachment to angiotensin-converting enzyme (ACE2) which helps the virus entry to host cells in humaSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
n and animals4 SARS-CoV-2 s glycoprotein is the antigen of choice for Covid-19 vaccine development due to its highly antigenic property5.Nanocovax is Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine ARS-CoV-2 s glycoproteins and aluminum hydroxide adjuvant. In rodent and monkey models. Nanocovax induced high levels of anti-S antibody (Ab). Neutralizing antibody titers were evaluated by microneutralization on Wuhan strain and surrogate virus neutralization test Importantly. Nanocovax conferred a Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine remarkable protection against SARS-CoV-2 infection 111 hamster challenge model6.Here we report the findings of the phase 1 and 2 trials started 111 DSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
ecember 2020 and February 2021 respectively, to evaluate the safety and immunogenicity of 25 mcg, 50 mcg and 75 mcg dose strengths of recombinant SARSSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine trial was conducted at the Military Medical University. Ha Noi. Vietnam. This was an open-labeled, dose-escalation study with the emphasis on the vaccine safety (figure SI). Eligible participants were healthy men and nonpregnant women. 18 to 50 years of age with body-mass index (BMI) of 18 to 27 kg Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine /nr (table SI). In this phase, 60 participants were allocated into 2:2:2 ratio of 25 mcg. 50 mcg and 75 mcg dose groups, respectively. For safety measSafety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine
ure, the first 3 participants of 25 mcg dose group were vaccinated and monitored for 72 hours After no SAE were observed, all remaining participants iSafety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", D Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine 50 mcg dose group, the remaining participant in this group plus 3 participants in 75 mcg dose group would be vaccinated If no SAE were observed amongThis preprint research paper has not been peer reviewed Electronic copy available at: https://ssm.com/abstract=3931736 Safety and immunogenicity of nanocovax a sarscovid 2 recombinant spike protein vaccine Safety and Immunogenicity of Nanocovax, a SARS-CoV-2 RecombinantSpike Protein VaccineThuy p. Nguyen AID‘".Ouyet Do A/D PhD2". Lan T. Phan A/D PhD3", DGọi ngay
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