A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate Efficacy, Safety and Immunogenicity of LIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and BIBP Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) in Healthy Population Aged 18 and Above

This clinical trial adopts a randomized, double-blind and placebo-controlled design.
A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.
Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.

开始日期2022-11-04

申办/合作机构

兰州生物制品研究所有限责任公司

[+2]

NCT05293548 / Active, not recruiting临床2期

A Randomized, Controlled Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) and Inactivated COVID-19 Vaccine (Vero Cell) in Population Aged 18 Years and Above

A total of 516 healthy subjects aged 18 years and above who have been vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine, will be enrolled, and randomly assigned to experimental group and control group in a 1:1 ratio, with 258 subjects in each sequential group.

开始日期2022-05-25

申办/合作机构

兰州生物制品研究所有限责任公司

[+2]

NCT05105295 / Unknown status临床4期

Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in People With Human Immunodeficiency Virus Infected

Evaluation of immunogenicity, safety and persistence of the subjects with HIV infected received the third dose of inactivated COVID-19 vaccine .

开始日期2021-12-01

申办/合作机构

中国生物技术股份有限公司

[+1]

100 项与广谱重组新冠疫苗NVSI-06-09 相关的临床结果

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100 项与广谱重组新冠疫苗NVSI-06-09 相关的转化医学

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100 项与广谱重组新冠疫苗NVSI-06-09 相关的专利（医药）

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项与广谱重组新冠疫苗NVSI-06-09 相关的文献（医药）

2024-01-06·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Immunogenicity, safety and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years].

Article

作者: Xing, B ; Cao, Y F ; Zhang, T Q ; Liao, Y T ; Hu, X S ; Yang, J ; Yao, D Y ; Lyu, H K ; Liang, Z Z ; Wang, X L ; Chen, Y P ; Ding, F

目的： 评价重组新型冠状病毒（新冠病毒）蛋白疫苗（CHO细胞）在18~84岁人群中异源序贯加强免疫的免疫原性、安全性和持久性。 方法： 采用多中心开放性试验设计，于2021年10月在浙江绍兴市上虞区和衢州市开化县2个研究现场，招募已完成2剂次新冠病毒灭活疫苗（Vero细胞）基础免疫3~9个月的18~84岁健康成年人为受试者；根据接种间隔时间分为A（3~4个月）、B（5~6个月）、C（7~9个月）3组，每组各320例，三组受试者均接种重组新冠病毒蛋白疫苗（CHO细胞）。在加强接种前、接种后14、30、180 d采集血液样本，分析比较不同组间的抗体几何平均滴度（GMT）、抗体阳性率和阳转率。收集接种后1个月内不良事件和6个月内的严重不良事件，分析不良反应发生率。 结果： 960例受试者年龄为（52.3±11.5）岁，男性占47.4%（455例）。加强接种14 d后B组和C组受试者GMT（95%CI）分别为65.26（54.51~78.12）和60.97（50.61~73.45），均高于A组受试者［GMT（95%CI）：44.79（36.94~54.30）］；加强接种30 d后B组和C组受试者的GMT（95%CI）分别为23.95（20.18~28.42）和27.98（23.45~33.39），均高于A组受试者［GMT（95%CI）：15.71（13.24~18.63）］，差异均具有统计学意义（均P<0.05）。加强接种14 d后，A、B、C三组受试者抗体阳性率分别为91.69%（276/301）、94.38%（302/320）、93.95%（295/314），抗体阳转率分别为90.37%（272/301）、93.75%（300/320）、93.31%（293/314），差异均无统计学意义（均P>0.05）；加强接种30 d后，抗体阳性率分别为79.60%（238/299）、87.74%（279/318）、90.48%（285/315），抗体阳转率分别为76.92%（230/299）、85.85%（273/318）、88.25%（278/315），差异均有统计学意义（均P<0.001）。960名受试者序贯加强免疫期间的不良事件发生率为15.31%（147/960），A、B、C三组分别为14.38%（46/320）、17.50%（56/320）、14.06%（45/320）；不良反应发生率为8.02%（77/960），三组分别为7.50%（24/320）、6.88%（22/320）、9.69%（31/320），未发生与接种疫苗有关严重不良事件。 结论： 完成新冠病毒灭活疫苗基础免疫3~9个月的18~84岁健康成年人序贯免疫接种重组新冠病毒蛋白疫苗的免疫原性和安全性均较好。.

2023-12-01·Immunity, Inflammation and Disease

Mucosal response of inactivated and recombinant COVID‐19 vaccines in Congolese individuals

Article

作者: Heinzel, Constanze ; Kreidenweiss, Andrea ; Fendel, Rolf ; Mbama Ntabi, Jacques D. ; Kremsner, Peter G. ; Lissom, Abel ; Ntoumi, Francine ; Mouzinga, Freisnel H. ; Ngumbi, Etienne ; Djontu, Jean C. ; Batchi‐Bouyou, Armel L.

AbstractBackgroundThe efficacy of immunization against an airborne pathogen depends in part on its ability to induce antibodies at the major entry site of the virus, the mucosa. Recent studies have revealed that mucosal immunity is poorly activated after vaccination with messenger RNA vaccines, thus failing in blocking virus acquisition upon its site of initial exposure. Little information is available about the induction of mucosal immunity by inactivated and recombinant coronavirus disease 2019 (COVID‐19) vaccines. This study aims to investigate this topic.MethodsSaliva and plasma samples from 440 healthy Congolese were collected including (1) fully vaccinated 2 month postvaccination with either an inactivated or a recombinant COVID‐19 vaccine and (2) nonvaccinated control group. Total anti‐severe acute respiratory syndrome coronavirus 2 receptor‐binding domain IgG and IgA antibodies were assessed using in‐house enzyme‐linked immunosorbent assays for both specimens.FindingsAltogether, the positivity of IgG was significantly higher in plasma than in saliva samples both in vaccinated and nonvaccinated control groups. Inversely, IgA positivity was slightly higher in saliva than in plasma of vaccinated group. The overall IgG and IgA levels were respectively over 103 and 14 times lower in saliva than in plasma samples. We found a strong positive correlation between IgG in saliva and plasma also between IgA in both specimens (r = .70 for IgG and r = .52 for IgA). Interestingly, contrary to IgG, the level of salivary IgA was not different between seropositive control group and seropositive vaccinated group. No significant difference was observed between recombinant and inactivated COVID‐19 vaccines in total IgG and IgA antibody concentration release 2 months postvaccination both in plasma and saliva.ConclusionInactivated and recombinant COVID‐19 vaccines in use in the Republic of Congo poorly activated mucosal IgA‐mediated antibody response 2 months postvaccination.

2023-08-01·Antiviral research

Intranasal delivery of an adenovirus-vector vaccine co-expressing a modified spike protein and a genetic adjuvant confers lasting mucosal immunity against SARS-CoV-2.

Article

作者: Park, Jang Hyun ; Ku, Keun Bon ; Kang, Byeong Hoon ; Kim, Kyun-Do ; Kim, Hyeon Cheol ; Jung, Hi Eun ; Lee, Heung Kyu

The ongoing COVID-19 pandemic caused by SARS-CoV-2 infection has threatened global health. Since the first case of infection was reported in December 2019, SARS-CoV-2 has rapidly spread worldwide and caused millions of deaths. As vaccination is the best way to protect the host from invading pathogens, several vaccines have been developed to prevent the infection of SARS-CoV-2, saving numerous lives thus far. However, SARS-CoV-2 constantly changes its antigens, resulting in escape from vaccine-induced protection, and the longevity of immunity induced by vaccines remains an issue. Additionally, traditional intramuscular COVID-19 vaccines are insufficient at evoking mucosal-specific immune responses. Because the respiratory tract is the primary route of SARS-CoV-2 entry, the need for mucosal vaccines is strong. Using an adenoviral (Ad) vector platform, we generated Ad5-S.Mod, a recombinant COVID-19 vaccine that encodes modified-spike (S) antigen and the genetic adjuvant human CXCL9. Intranasal delivery of Ad5-S.Mod elicited superior airway humoral and T-cell responses over traditional intramuscular vaccines and protected mice from lethal SARS-CoV-2 infection. cDC1 cells were required for the generation of antigen-specific CD8⁺ T-cell responses and CD8⁺ tissue-resident memory T-cell development in intranasal Ad5-S.Mod vaccinated mice. Furthermore, we confirmed the efficacy of the intranasal Ad5-S.Mod vaccine in terms of transcriptional changes and identified lung macrophages as a key supporter of maintenance of lung-resident memory T and B cells. Our study demonstrates Ad5-S.Mod has the potential to confer protective immunity against SARS-CoV-2 and that lung macrophages support the maintenance of vaccine-induced tissue-resident memory lymphocytes.

项与广谱重组新冠疫苗NVSI-06-09 相关的新闻（医药）

2022-12-15

·药创客

广谱重组新冠疫苗获阿联酋批准紧急使用

2022年12月12日，国药集团中生生物技术研究院/新型疫苗国家工程研究中心（简称中国生物研究院）研发的广谱重组新冠疫苗NVSI-06-09获得阿联酋紧急使用授权。NVSI-06-09是针对包含Omicron在内的多种变异株，基于嵌合型抗原设计思路，研发的一种具有广谱中和效果的重组新冠疫苗，疫苗设计及临床前研究结果发表在eLife期刊¹。阿联酋开展的序贯临床（CNBG-REC-2022004）研究结果显示，在既往接种了2-3针灭活疫苗的受试者中，加强免疫一针NVSI-06-09，可以诱导产生针对Omicron各亚型（包括BA.1.1、BA.2、BA.4和BA.5）、Delta、Beta等多种变异株的高滴度广谱中和抗体。序贯加强后14天，针对Omicron各亚型的抗体滴度相较于免前提高了22.4-42.3倍。临床研究结果已被Signal Transduction and Targeted Therapy期刊接收²。同时，考虑到加强免疫的安全性，NVSI-06-09采用了长期广泛使用的氢氧化铝佐剂，在包括儿童和老年人在内的3岁以上各年龄人群中均显示出良好的安全性和耐受性。NVSI-06-09可以作为通用加强针，应用于不同年龄组人群，提供针对新冠病毒包括Omicron在内的多种变异株的广泛保护潜力。目前，广谱重组新冠疫苗NVSI-06-09由国药集团中国生物所属子公司承担生产任务，预计年产能可达12亿剂。参考文献：1.https://elifesciences.org/articles/786332.https://www.medrxiv.org/content/10.1101/2022.09.05.22279589v1 End 声明：本文旨在传递更多信息，版权归原作者所有。原创文章转载均需经过授权并注明来源，如涉及内容、版权或其他问题请时联系小编删除！文章仅代表作者个人观点，并不代表公众号立场。本公众号拥有对此声明的最终解释权！投稿邮箱：yck19876@163.com

疫苗临床结果临床研究

100 项与广谱重组新冠疫苗NVSI-06-09 相关的药物交易

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