Comparative Study of Patterns of Immune Response to COVID 19 Vaccination

NCT05408299 | Unknown

• 1 other identifier: 03/22-0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An effective vaccine stands as the most effective way for controlling the COVID 19 pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cell responses against the structural proteins have been found to be the most immunogenic in peripheral blood mononuclear cells of convalescent SARS-CoV1 patients which needs to be tested in SARS -COV2 vaccine efficacy studies alongside with the sustainability of humoral and cellular immune responses . Clinically , immunocompromised patients face drastic outcome of infections , which led the Advisory Committee on Immunization Practices (ACIP) - USA -and the Joint Committee on Vaccination and Immunisation (JCVI) -UK- recommend COVID-19 vaccination of immunocompromised , the WHO Strategic Advisory Group of Experts on Immunization (SAGE), recommended that the three vaccines(Pfizer ,Moderna and Astra Zeneca) can be used for individuals with high-risk comorbidities . Nevertheless, there is an unmet research need concerning the immune response towards COVID 19 vaccination in this population . Based on the previous work of our team in designing B and T cell epitopes distributed over the S protein , we will study the immune response in the available vaccines in Egypt.

Conditions

Immune Response to Covid 19 Vaccination

Outcome Measures

Primary Outcomes (2)

• Studying the immune response to COVID -19 vaccination

  Detection of total induced IgG binding antibodies

  Month 3-Month 9 of the study

• . Comparing immune response to COVID 19 vaccination between healthy and immunocompromised groups

  Month 3 - Month 9 of the study

Secondary Outcomes (1)

• . Determination of the most immunogenic parts of COVID 19 vaccine

  Month 3-Month 9 of the study

Study Arms (2)

Immunocompetent

100 healthy persons not suffering of any systemic diseases or malignancy of whatever nature.

Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)

Immunocompromised

100 B thalassemia splenectomised patients.

Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)

Interventions

Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm) BIOLOGICAL

Vaccination

Immunocompetent; Immunocompromised

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will comprise 200 subjects divided into 2 groups; Group 1 : 100 healthy subjects not suffering of systemic diseases vaccinated at any of the MOH vaccination centers. Group 2: 100 B thalssemia splenectomised patients representing an immunocompromised cohort.

You may qualify if:

• Both sexes.
• weeks post scheduled first vaccination dose
• Healthy group not suffering from any systemic diseases.
• B thalassemia major splenectomized group
• Signing an informed consent .

You may not qualify if:

• Malignancy of whatever nature. 2- Systemic diseases apart from B thalassemia for the B thalassemia group. 3- Previous infection with COVID 19 . 4- Refusal to sign the informed consent .

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• The holding company for biological products and vaccines (VACSERA): collaborator
• Theodor Bilharz Research Institute: collaborator

Study Sites (1)

National Research Center

Cairo, Dokki, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells

Study Officials

• Mohamed A Mokhles, Professor

  National Research Center .

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Mokhles, Professor

CONTACT

+201223407520; mohamad.mokhles@gmail.com

Reeham H Dawood, Professor

CONTACT

+201004050989; rmhaemd@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 7, 2022
• Study Start: June 20, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AT month 12 of the study

Locations

EG (1)