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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Astrazenica vaccine
Sponsored by
Samia Hassan El-Shishtawy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All male and female above 18 years

Exclusion Criteria:

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

Sites / Locations

  • Samia El-ShishtawyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

1- Before vaccination:

2-7 days after the first dose

3-Before the second dose:

4-After 3 months from the second dose:

5-After 6 months from the second dose:

Arm Description

To detect: COVID-19 IgG/IgM Rapid Test COVID-19 IgG/IgM by quantitative method(ELISA). D-dimer

Measuring D-dimer

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2021
Last Updated
August 29, 2021
Sponsor
Samia Hassan El-Shishtawy
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1. Study Identification

Unique Protocol Identification Number
NCT05017792
Brief Title
Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
Official Title
Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Samia Hassan El-Shishtawy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1- Before vaccination:
Arm Type
Other
Arm Description
To detect: COVID-19 IgG/IgM Rapid Test COVID-19 IgG/IgM by quantitative method(ELISA). D-dimer
Arm Title
2-7 days after the first dose
Arm Type
Other
Arm Description
Measuring D-dimer
Arm Title
3-Before the second dose:
Arm Type
Other
Arm Description
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.
Arm Title
4-After 3 months from the second dose:
Arm Type
Other
Arm Description
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.
Arm Title
5-After 6 months from the second dose:
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Astrazenica vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
to develop IgG antibody
Description
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.
Time Frame
seven to ten days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
ABOVE 18 YEARS
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All male and female above 18 years Exclusion Criteria: age below 18 years -pregnancy- fever IGM positive for covid 19
Facility Information:
Facility Name
Samia El-Shishtawy
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samia H El-Shishtawy, Assi. prof
Phone
01003661563
Email
crc.tbri@gmai.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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