Effects of COVID 19 Vaccine on Egyptian Population

March 20, 2021 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HCWs in Assiut University Hospitals accepted to take vaccine

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serological antibodies against SARS-CoV-2 e
Time Frame: 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
Time Frame: one month after second dose
Total IgG titer
one month after second dose
Complete blood count (CBC)
Time Frame: 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)
Time Frame: one month after second dose
to evaluate total leucocyte count TLC
one month after second dose
Complete blood count (CBC)
Time Frame: 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)
Time Frame: one month after second dose
absolute neutrophilic count (ANC)
one month after second dose
Complete blood count (CBC)
Time Frame: change from baseline at one month after first dose
platelets (PLTs)
change from baseline at one month after first dose
Complete blood count (CBC)
Time Frame: one month after second dose
platelets (PLTs)
one month after second dose
Complete blood count (CBC)
Time Frame: change from baseline at one month after first dose
hemoglobin level
change from baseline at one month after first dose
Complete blood count (CBC)
Time Frame: one month after second dose
hemoglobin level
one month after second dose
Adverse clinical symptoms after vaccine
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 20, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID 19 Vaccine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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