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Effects of COVID 19 Vaccine on Egyptian Population

2021年3月20日 更新者:Mariam Roshdy Elkhayat、Assiut University

Impact of COVID 19 Vaccine on Safety, Blood Elements, and Immunogenicity of the Egyptian Population

The aim of this study is to identify adverse events following vaccination by the COVID-19 vaccine by evaluating adverse side effects, hematological values; immunogenicity in the Egyptian candidates in response to COVID-19 vaccine, summarizing the which may occur following administration of COVID-19 vaccine.

研究概览

详细说明

Coronavirus disease 2019 (COVID-19) is an emerging respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that had infected more than 100 million individuals and caused more than 2 million deaths worldwide by February 13, 2021. A safe and effective vaccination trials against COVID-19 is urgently needed. There are currently more than 160 COVID-19 candidate vaccines in development worldwide, and 25 are in different phases of clinical trials using different platforms.

The efficacy and immunogenicity of vaccines varies depending on the study cohort. Race and ethnicity were shown to affect the antibody responses to the rubella vaccine, which elicited significantly higher titers in children of African ethnicity compared to those of European descent or Hispanic ethnicity, likely, disparities in serologic responses to vaccines were also observed between different ethnic groups for the Haemophilus influenzae type b-tetanus toxoid conjugate vaccine , or the Haemophilus influenzae type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine . thus keeping the race an important factor in studding its effect on immunogenicity of vaccine. Thus keeping the race an important factor in studding its effect on immunogenicity of vaccine, which pushed us to estimate immunogenicity in Egyptian population after vaccination with the inactivated COVID-19 vaccine.

Heamatological changes after vaccination had been detected in many researches; lecuocytosis was found shortly after vaccination of infants, which was primarily a neutrophilia but no participant received antibiotics and all remained well at follow-up . In a case series study, also leukocytosis with fever was detected following pneumococcal vaccine administration . On the other hand, neutropenia was detected following a new vaccine against Shigella sonnei . Platelets abnormalities also had been detected following vaccination, a previous example is idiopathic thrombocytopenic purpura, linked to the administration of measles-containing vaccines .

研究类型

观察性的

注册 (预期的)

800

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

HCWs in Assiut University Hospitals accepted to take vaccine

描述

Inclusion Criteria:

  1. People aged 18-80 years.
  2. Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.

Exclusion Criteria:

  1. A history of infection with SARS-CoV 3 months before the vaccine.
  2. Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
  3. Pregnancy.
  4. A history of seizures or mental illness.
  5. Being on immunosuppressive agents.
  6. Being on anticoagulation therapy.
  7. Being unable to comply with the study schedule.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
serological antibodies against SARS-CoV-2 e
大体时间:change from baseline at one month after first dose
Total IgG titer
change from baseline at one month after first dose
serological antibodies against SARS-CoV-2 e
大体时间:one month after second dose
Total IgG titer
one month after second dose
Complete blood count (CBC)
大体时间:change from baseline at one month after first dose
to evaluate total leucocyte count TLC
change from baseline at one month after first dose
Complete blood count (CBC)
大体时间:one month after second dose
to evaluate total leucocyte count TLC
one month after second dose
Complete blood count (CBC)
大体时间:change from baseline at one month after first dose
absolute neutrophilic count (ANC)
change from baseline at one month after first dose
Complete blood count (CBC)
大体时间:one month after second dose
absolute neutrophilic count (ANC)
one month after second dose
Complete blood count (CBC)
大体时间:change from baseline at one month after first dose
platelets (PLTs)
change from baseline at one month after first dose
Complete blood count (CBC)
大体时间:one month after second dose
platelets (PLTs)
one month after second dose
Complete blood count (CBC)
大体时间:change from baseline at one month after first dose
hemoglobin level
change from baseline at one month after first dose
Complete blood count (CBC)
大体时间:one month after second dose
hemoglobin level
one month after second dose
Adverse clinical symptoms after vaccine
大体时间:up to one week after first dose

asking about possible recorded side effects as

  • Local: irritation, erythema, swelling, or itching.
  • Systemic: headache, dizziness, difficult sleep, flush, muscle pain, joint pain, fatigue, fever, chills, sore throat, nasal congestion, nasal bleeds, sneezing, runny nose, cough, dyspnoea, palpitation, nausea, vomiting, diarrhoea, constipation, stomach pain, loss of appetite, acute allergic reaction, acne, abnormal taste, loss of taste, mouth ulcers, toothache, ear pain, eye pain, and/or lymphadenopathy.
up to one week after first dose

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年3月1日

初级完成 (预期的)

2021年9月1日

研究完成 (预期的)

2021年12月30日

研究注册日期

首次提交

2021年3月14日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月22日

研究记录更新

最后更新发布 (实际的)

2021年3月24日

上次提交的符合 QC 标准的更新

2021年3月20日

最后验证

2021年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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