新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物)(COVID 2019 vaccine (Shenzhen Kangtai Biological Products)) - 药物靶点：SARS-CoV-2 antigen_在研适应症：新型冠状病毒感染_专利_临床

A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years

This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.

开始日期2021-09-01

申办/合作机构

深圳康泰生物制品股份有限公司

[+2]

NCT05003479 / Unknown status临床1期

A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.

开始日期2021-08-01

申办/合作机构

深圳康泰生物制品股份有限公司

[+2]

NCT04852705 / Unknown status临床3期

A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older

The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.

开始日期2021-05-01

申办/合作机构

深圳康泰生物制品股份有限公司

[+1]

100 项与新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物) 相关的临床结果

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100 项与新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物) 相关的转化医学

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100 项与新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物) 相关的专利（医药）

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6

项与新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物) 相关的文献（医药）

2023-05-01·Ophthalmology

Navigating Coronavirus Disease 2019 Vaccination and Uveitis

Article

作者: Niederer, Rachael L ; Allen, Natalie ; Jordan, Charlotte A ; Townend, Stephanie ; McGhee, Charles N J ; Sims, Joanne

PURPOSE:

To identify rates of uveitis reactivation both before and after the coronavirus disease (COVID) 2019 vaccine in subjects with a previous diagnosis of uveitis.

DESIGN:

Retrospective study.

PARTICIPANTS:

Subjects were identified from the Inflammatory Eye Disease Registry at Auckland District Health Board diagnosed with uveitis between January 1, 2010, and December 31, 2020.

METHODS:

Date of COVID vaccination was determined from the patient clinical record. Rate of flare was calculated for 3 months before vaccination and 3 months after each vaccination.

MAIN OUTCOME MEASURE:

Uveitis flare was defined as the presence of new uveitis activity or increased activity that required a change in uveitis treatment.

RESULTS:

A total of 4184 eyes of 3008 patients were included in the study with a total of 8474 vaccinations given during the study period. Median age was 54.8 years, and 1474 (49.0%) were female. Noninfectious etiology was most common, occurring in 2296 patients (76.3%) and infectious etiology occurring in 712 patients (23.7%). Rate of uveitis flare was 12.3 per 1000 patient-months at baseline, 20.7 after the first dose, 15.0 after the second dose, 12.8 after the third dose, and 23.9 after the fourth dose. The median period of quiescence before flare was 3.9 years. An increase in uveitis flare was seen in both infectious uveitis (baseline 13.1 compared with 20.2 after first dose, 154% increase) and noninfectious uveitis (baseline 12.4 compared with 20.9 after first dose, 169% increase). Risk factors for uveitis flare were identified to be recurrent uveitis, chronic uveitis, shorter period of quiescence, and first dose of vaccine. Median time to uveitis flare was 0.53 months after the first vaccination, 1.74 months after the second vaccination, and 1.35 months after the third vaccination.

CONCLUSIONS:

The current study demonstrates an increased risk of uveitis flare after the first dose of COVID vaccination. This risk was highest in those with previous recurrences, chronic uveitis, and shorter period of quiescence.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

2023-01-01·Neurology India

Post-Vaccination/Post-COVID Immune-Mediated Demyelination of the Brain and Spinal Cord

Article

作者: Mahajan, Ashima ; Oinam, Rahul ; Mishra, Biswa Mohan ; Anand, Pooja ; Sharma, Kalyan ; Nayak, Manoj K ; Padma Srivastava, M Vasantha ; Gaikwad, Shailesh B

Introduction::

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19), which not only produces respiratory symptoms but is known to involve almost every system, and its neuroinvasive properties have been well demonstrated throughout the pandemic. Also, to combat the pandemic, there was rapid development and induction of various vaccination drives, following which many adverse events following immunization (AEFIs) have been reported, which include neurological complications as well.

Method::

We present a series of three cases, post vaccination, with and without a history of COVID illness that showed remarkably similar findings on magnetic resonance imaging (MRI).

Result::

A 38-year-old male presented with complaints of weakness of the bilateral lower limbs with sensory loss and bladder disturbance a day after receiving his first dose of ChadOx1 nCoV-19 (COVISHIELD) vaccine. A 50-year-old male with hypothyroidism characterized by autoimmune thyroiditis and impaired glucose tolerance experienced difficulty in walking 11.5 weeks after being administered with COVID vaccine (COVAXIN). A 38-year-old male presented with subacute onset progressive symmetric quadriparesis 2 months after their first dose of a COVID vaccine. The patient also had sensory ataxia, and his vibration sensation was impaired below C7. All three patients had typical pattern of involvement of the brain and spine on MRI with signal changes in bilateral corticospinal tracts, trigeminal tracts in the brain, and both lateral and posterior columns in the spine.

Conclusion::

This pattern of brain and spine involvement on MRI is a novel finding and is likely a result of post-vaccination/post-COVID immune-mediated demyelination.

2021-06-24·Nature1区 · 综合性期刊

CureVac COVID vaccine let-down spotlights mRNA design challenges

1区 · 综合性期刊

作者: Dolgin, Elie

Scientists are searching for explanations to disappointing final-stage trial results.These insights could help guide the future development of mRNA vaccines.

100 项与新型冠状病毒灭活疫苗（Vero细胞）(深圳康泰生物) 相关的药物交易

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