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

Study Overview
=================
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.

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

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Biological: Astrazenica vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All male and female above 18 years Exclusion Criteria: age below 18 years -pregnancy- fever IGM positive for covid 19

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 5 blood samples will be taken: Each one is 5 cm as following 1- Before vaccination: To detect: COVID-19 IgG/IgM Rapid Test COVID-19 IgG/IgM by quantitative method(ELISA). D-dimer COVID-19 IgM detection COVID-19 IgG detection D-dimer Measuring D-dimer 3-Before the second dose: To detect IgG and IgM To detect the level of Covid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine. 4-After 3 months from the second dose: To detect the level ofCovid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine. 5-After 6 months from the second dose: To detect the level ofCovid 19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1- Before vaccination:<br>To detect: COVID-19 IgG/IgM Rapid Test COVID-19 IgG/IgM by quantitative method(ELISA). D-dimer | Biological: Astrazenica vaccine<br>* 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.<br>|
| Other: 2-7 days after the first dose<br>Measuring D-dimer | Biological: Astrazenica vaccine<br>* 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.<br>|
| Other: 3-Before the second dose:<br>To detect IgG and IgM To detect the level of Covid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine. | Biological: Astrazenica vaccine<br>* 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.<br>|
| Other: 4-After 3 months from the second dose:<br>To detect the level ofCovid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine. | Biological: Astrazenica vaccine<br>* 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.<br>|
| Other: 5-After 6 months from the second dose:<br>To detect the level ofCovid 19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured. To detect the response of the immune system to the vaccine. | Biological: Astrazenica vaccine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to develop IgG antibody | These antibodies indicate that you may have had COVID 19 in the recent past and have developed antibodies that may protect you from future infection. It is unknown at this point how much protectionantibodies might provide against reinfection. This group of individuals should receive the vaccine. Quantitative Ig G titer should be measured. | seven to ten days |