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

Phase 3

• Conditions: Covid19
• Interventions: Biological: Astrazenica vaccine

• Registration Number: NCT05017792
• Lead Sponsor: Samia Hassan El-Shishtawy

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-24
• Last Update Submitted: 2021-08-29
• Study Start: 2021-08-30
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All male and female above 18 years

Exclusion Criteria

• age below 18 years -pregnancy-
• fever
• IGM positive for covid 19

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2-7 days after the first dose	Astrazenica vaccine	Measuring D-dimer
1- Before vaccination:	Astrazenica vaccine	To detect: * COVID-19 IgG/IgM Rapid Test * COVID-19 IgG/IgM by quantitative method(ELISA). * D-dimer
5-After 6 months from the second dose:	Astrazenica vaccine	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.
4-After 3 months from the second dose:	Astrazenica vaccine	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.
3-Before the second dose:	Astrazenica vaccine	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.

Primary Outcome Measures

Name	Time	Method
to develop IgG antibody	seven to ten days	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.

Trial Locations

Locations (1)

Samia El-Shishtawy; 🇪🇬 Giza, Egypt