Skip to content

Effects of COVID 19 Vaccine on Egyptian Population

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04809948
Enrollment
800
Registered
2021-03-22
Start date
2021-03-31
Completion date
2021-12-30
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19 Vaccine

Brief summary

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.

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 .

Interventions

BIOLOGICALviral vector vaccine

AstraZeneca vaccine

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
serological antibodies against SARS-CoV-2 echange from baseline at one month after first doseTotal IgG titer
Complete blood count (CBC)change from baseline at one month after first doseto evaluate total leucocyte count TLC
Adverse clinical symptoms after vaccineup to one week after first doseasking 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.

Contacts

Primary ContactMariam Elkhayat, lecturer
mariam.elkhayat@aun.edu.eg01003708261
Backup ContactTaghreed Meshref, lecturer
tagreed.meshref@aun.edu.eg01003651135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026