An effective vaccine stands as the most effective way for controlling the COVID 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent SARS-CoV1 patients which needs to be tested in SARS -COV2 vaccine efficacy studies alongside with the sustainability of humoral and cellular immune responses . Clinically , immunocompromised patients face drastic outcome of infections , which led the Advisory Committee on Immunization Practices (ACIP) - USA -and the Joint Committee on Vaccination and Immunisation (JCVI) -UK- recommend COVID-19 vaccination of immunocompromised , the WHO Strategic Advisory Group of Experts on Immunization (SAGE), recommended that the three vaccines(Pfizer ,Moderna and Astra Zeneca) can be used for individuals with high-risk comorbidities . Nevertheless, there is an unmet research need concerning the immune response towards COVID 19 vaccination in this population .
Based on the previous work of our team in designing B and T cell epitopes distributed over the S protein , we will study the immune response in the available vaccines in Egypt.

Start Date20 Jun 2022

Sponsor / Collaborator

Theodor Bilharz Research Institute

NCT05408312 / Active, not recruitingPhase 1

Phase I Clinical Trial of Safety, Tolerance and Immunogenicity of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older.
A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.

Start Date18 Jun 2022

Sponsor / Collaborator

Lanzhou Institute of Biological Products Co. Ltd.

[+1]

NCT05069129 / RecruitingPhase 1/2

A Randomized, Controlled Phase I and Sequential Study to Evaluate the Safety and Immunogenicity Following Immunization of GEN2-Recombinant COVID-19 Vaccine (CHO Cells,NVSI-06-08) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above

This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 4-6 months, 7-9 months and >9 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.

Start Date14 Oct 2021

Sponsor / Collaborator

Lanzhou Institute of Biological Products Co. Ltd.

[+1]

100 Clinical Results associated with Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

100 Translational Medicine associated with Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

100 Patents (Medical) associated with Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

Literatures (Medical) associated with Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

01 Feb 2022·Frontiers of MedicineQ3 · MEDICINE

Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization in Chinese adults

Q3 · MEDICINE

Article

Author: Zhang, Xinxin ; Liu, Feng ; Qiao, Niu ; Ding, Ling ; Yang, Yunkai ; Liang, Yu ; Han, Zibo ; Zhang, Yuntao ; Zhu, Xiujuan ; Wang, Xuewei ; Yang, Xiaoming

Inducing durable and effective immunity against severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) via vaccination is essential to combat the current pandemic of coronavirus disease 2019 (COVID-19). It has been noticed that the strength of anti-COVID-19 vaccination-induced immunity fades over time, which calls for an additional vaccination regime, as known as booster immunization, to restore immunity among previously vaccinated populations. Here we report a pilot open-label trial of a third dose of BBIBP-CorV, an inactivated SARS-CoV-2 vaccine (Vero cell), on 136 participants aged between 18 to 63 years. Safety and immunogenicity in terms of neutralizing antibody titers and cytokine/chemokine responses were analyzed as the main endpoint until day 28. While systemic reactogenicity was either absent or mild, SARS-CoV-2-specific neutralizing antibody titers rapidly arose in all participants within 4 weeks, surpassing the peak antibody titers elicited by the initial two-dose immunization regime. Broad increases of cellular immunity-associated cytokines and chemokines were also detected in the majority of participants after the third vaccination. Furthermore, in an exploratory study, a newly developed recombinant protein vaccine, NVSI-06-08 (CHO Cells), was found to be safe and even more effective than BBIBP-CorV in eliciting humoral immune responses in BBIBP-CorV-primed individuals. Together, these results indicate that a third immunization schedule with either homologous or heterologous vaccine showed favorable safety profiles and restored potent SARS-CoV-2-specific immunity, providing support for further trials of booster vaccination in larger populations.

Nature CommunicationsQ1 · CROSS-FIELD

Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Q1 · CROSS-FIELD

ArticleOA

Author: Hussein, Salah ; Cong, Xiangfeng ; Yang, Yun Kai ; Zhang, Jin ; Zhang, Xue ; Kang, Yun ; Yin, Jin Liang ; Liang, Yu ; Lei, Wenwen ; Mao, Xiao Yan ; Liu, Dan Ying ; Li, Qi Ming ; Wang, Zhao Nian ; Kaabi, Nawal Al ; Xu, Ke ; Yang, Mengjie ; Wang, Hui ; Yang, Sen Sen ; Eltantawy, Islam ; Shao, Shuai ; Zhang, Yun Tao ; Qu, Chang ; Yang, Tian ; Yang, Xiao Ming ; Su, Ji Guo ; Jiang, Zhiwei ; Mekki, Hanadi Mekki ; Xiao, Peng ; Qu, Liang ; Gao, Xue Jun ; Mahmoud, Sally ; Wu, Guizhen ; Zhang, Jing ; Tan, Yao ; Zaher, Walid ; ElDein, Mohamed Saif ; Li, Meng ; Lei, Ze Hua ; Du, Li Fang ; Hou, Jun Wei

AbstractNVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

100 Deals associated with Recombinant COVID-19 vaccine(CHO cell)(National Vaccine & Serum Institute)

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Indication	Country/Location	Organization	Date
COVID-19	AE	Sinopharm Zhongsheng Biotechnology Research Institute Co., Ltd	27 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	CN	-	25 Apr 2021

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