Official Title
Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
Brief Summary

Evaluation of the efficacy of the AstrazenicaCovid 19 vaccine to develop IgG antibody and its level based on th12 weeks program. Also to follow the changes of markers of coagulation (D-dimer) after vaccination compared to the basic level. A cardiology consultant will follow D-Dimer results to be managed properly if there is a need. As it is expected to receive Sinopharm vaccine there will be comparison between results of the two types of vaccine. To our knowledge this will be the first study done on Egyptian population.

Detailed Description

SARS-CoV-2 has been in the human population for more than a year now, causing severe disease
in some and resulting in a pandemic that continues to put severe strain on economies and
healthcare infrastructures worldwide. Vaccination is considered as one of the greatest
successes in medical history. Based on prior experience with the development of SARS-CoV
vaccines, all COVID-19 vaccines must be subjected to the tests for protective effects and
harmful risks derived from antibody-dependent enhancement that may contribute to augmented
infectivity and/or eosinophilic infiltration. The SARS-CoV-2 vaccine is now being developed
urgently in several different ways.

In the UK, the first three vaccines have emergency use authorization, and a national rollout
is in progress. Many other countries are also instigating large scale vaccination programmes.
Assessment of the safety and efficacy of vaccines against the severe acute respiratory
syndrome coronavirus (SARS-CoV-2) in different populations is essential .

The UK government recently decided to extend the interval between the first dose of the
Pfizer BioNTech and AstraZeneca COVID-19 vaccines from 3 weeks to 12 weeks to maximise the
number of people receiving the initial dose, despite the trials only providing vaccine
efficacy data based on a schedule of 21 days between doses.

Many reports were raised claiming Astrazenica vaccine for the development of vascular
thrombosis and studies are not finalized regarding this issue .

China is regarded as one of the world's leading countries in SARS-CoV-2 vaccine development,
up to date the last inactivated vaccine international clinical (Phase III) trial was launched
in the United Arab Emirates by Sinopharm China National Biotec Group (CNBG).The ability to
track and trace vaccines through the vaccine supply chain down to persons vaccinated has to
be enhanced.

Recruiting
COVID19

Biological: Astrazenica vaccine

COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm. Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.

Eligibility Criteria

Inclusion Criteria:

- All male and female above 18 years

Exclusion Criteria:

- age below 18 years -pregnancy-

- fever

- IGM positive for covid 19

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Egypt
Locations

Samia El-Shishtawy
Giza, Egypt

Investigator: Samia H El-Shishtawy, Assi. prof
Contact: 01003661563
crc.tbri@gmai.com

Samia Hassan El-Shishtawy
NCT Number
MeSH Terms
COVID-19