COVAX 19(COVAX 19) - 药物靶点：SARS-CoV-2 S protein_在研适应症：新型冠状病毒感染，流感病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

Adjuvanted COVID2019 vaccine Vaxine、COVAX19 vaccine、SpikoGen

靶点

SARS-CoV-2 S protein

作用机制

SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 COVAX 19 相关的临床试验

NCT06355232 / Recruiting临床1期

A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines

The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.

开始日期2024-05-01

申办/合作机构

Vaxine Pty Ltd.

NCT05148871 / Active, not recruiting临床2/3期

A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)

A study to assess the effect of varying the time interval between doses on the immunogenicity of an adjuvanted recombinant spike protein Covid-19 vaccine (Spikogen/Covax-19)

开始日期2022-03-01

申办/合作机构

Vaxine Pty Ltd.

[+1]

NCT05231590 / Completed临床3期

A Non-Randomized, Three-Armed, Open-Label, Parallel-Group, Non-Inferiority Trial to Compare the Immunogenicity and Safety of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Children Aged 5 to <12 Years and 12 to <18 Years With Adults Aged 18 to 40 Years

This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to <12 years and 12 to <18 years with adults aged 18 to 40 years. Children aged 12 to <18 years and adults received 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to <12 years received a half-dose of the adjuvanted vaccine. The injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse events were collected through one month after the second dose. Safety monitoring was continued through six months after the second dose in children aged 5 to <12 years and 12 to <18 years.

开始日期2022-02-23

申办/合作机构

CinnaGen Co.

[+1]

100 项与 COVAX 19 相关的临床结果

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100 项与 COVAX 19 相关的转化医学

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100 项与 COVAX 19 相关的专利（医药）

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14

项与 COVAX 19 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine

Review

作者: Petrovsky, Nikolai

Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.

2024-03-12·Iranian journal of immunology : IJI

Comparative Immunogenicity and Neutralization Potency of Four Approved COVID-19 Vaccines in BALB/c Mice.

Article

作者: Jeddi-Tehrani, Mahmood ; Amiri, Mohammad Mehdi ; Shokri, Fazel ; Zarnani, Amir-Hassan ; Dashti, Navid ; Golsaz-Shirazi, Forough

Background:

Since the outbreak of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), several vaccine candidates have been developed within a short period of time. Although the potency of these vaccines was evaluated individually, their comparative potency was not comprehensively evaluated.

Objective:

To compare the immunogenicity and neutralization efficacy of four approved COVID-19 vaccines in Iran, including: PastoCovac Plus, Sinopharm, SpikoGen, and Noora in BALB/c mice.

Methods:

Different groups of female BALB/c mice were vaccinated with three doses of each vaccine. The serum levels of antibodies against the viral receptor binding domain (anti-RBD) and spike (anti-spike) protein as well as the vaccine formulation (anti-vaccine) were evaluated using enzyme-linked immunosorbent assay (ELISA). The neutralization efficacy of these four vaccines was assessed through four neutralization assays: conventional virus neutralization test (cVNT), pseudotype virus neutralization test (pVNT), surrogate virus neutralization test (sVNT), and inhibition flow cytometry.

Results:

All four vaccines induced seroconversion in vaccinated animals. All vaccines successfully induced high levels of anti-vaccine antibody; however, PastoCovac Plus and Sinopharm vaccines induced significantly higher levels of anti-RBD antibody titer compared to Noora and SpikoGen. Moreover, the results of the antibody response were corroborated by the virus neutralization tests, which revealed very weak neutralization potency by Noora and SpikoGen in all tests.

Conclusion:

Our results indicate significant immunogenicity and neutralization efficacy induced by PastoCovac Plus and Sinopharm, but not by Noora and SpikoGen. This suggests the need for additional comparative assessment of the potency and efficacy of these four vaccines in vaccinated subjects.

2024-01-01·International immunopharmacology

Comparative immunogenicity and safety of SpikoGen®, a recombinant SARS-CoV-2 spike protein vaccine in children and young adults: An immuno-bridging clinical trial

Article

作者: Kafi, Hamidreza ; Mamishi, Setareh ; Shahpari, Ramin ; Petrovsky, Nikolai ; Roshanzamir, Khashayar ; Soltani, Adele ; Anjidani, Nassim ; Yazdani, Babak ; Ebrahimi, Hamidreza ; Oveisi, Soudabeh ; Barati, Saghar ; Ebrahimi, Ali ; Tabarsi, Payam ; Fallah, Newsha

BACKGROUND:

SpikoGen® is a recombinant subunit spike protein ectodomain vaccine manufactured in insect cells and formulated with the novel polysaccharide-based Advax-CpG55.2 adjuvant. This study aimed to compare the immunogenicity and safety of SpikoGen® vaccine in children, adolescents and young adults.

METHODS:

This was a non-randomized, three-arm, open-label, parallel-group, immuno-bridging, non-inferiority trial to compare the immunogenicity and safety of a primary course of two intramuscular doses of SpikoGen® vaccine in children aged 5 to < 12 years, adolescents aged 12 to < 18 years and young adults aged 18 to 40 years. Children 5-12 years received a half dose of 12.5 μg spike protein, whereas the other groups received the full vaccine dose. Vaccine immunogenicity was evaluated via assessment of serum anti-spike and neutralizing antibodies 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Safety assessments including serious adverse events were continued through six months after the second dose in children and adolescents.

RESULTS:

Two weeks after the second dose, seroconversion rates for neutralizing antibody levels were not significantly different for children (59.50 %), adolescents (52.06 %) and adults (56.01 %). The 95 % confidence interval of the difference in seroconversion rates between children and adults was within the prespecified non-inferiority margin of 10 % (-12 % to 5 %). SpikoGen® vaccine was well tolerated in all age groups with the most common solicited adverse events being injection site pain and fatigue which were generally transient and mild.

CONCLUSION:

SpikoGen® vaccine was shown to be safe, well tolerated and immunogenic in children as young as 5 years of age, with non-inferior responses to those seen in adults. The Iranian FDA authorisation of SpikoGen® vaccine is now extended down to 5 years of age.

100 项与 COVAX 19 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	澳大利亚	Vaxine Pty Ltd.	2022-09-07
新型冠状病毒感染	临床3期	澳大利亚	CinnaGen Co.	2022-09-07
流感病毒感染	临床1期	澳大利亚	Vaxine Pty Ltd.	2024-05-01
严重急性呼吸综合征	临床1期	澳大利亚	Vaxine Pty Ltd.	2020-06-30