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

NCT05017792 | Unknown Phase 3 DMC

• 1 other identifier: 00022021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

1- Before vaccination:

OTHER

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

Biological: Astrazenica vaccine

2-7 days after the first dose

OTHER

Measuring D-dimer

Biological: Astrazenica vaccine

3-Before the second dose:

OTHER

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

4-After 3 months from the second dose:

OTHER

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

5-After 6 months from the second dose:

OTHER

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

Interventions

Astrazenica vaccine BIOLOGICAL

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.

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:

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: ABOVE 18 YEARS
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male and female above 18 years

You may not qualify if:

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

Sponsors & Collaborators

• Samia Hassan El-Shishtawy: lead

Study Sites (1)

Samia El-Shishtawy

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 24, 2021
• Study Start: August 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)