Comparative Study of Patterns of Immune Response to COVID 19 Vaccination

Comparative Study of Patterns of Immune Response to COVID 19 Vaccination Between Immunocompetent and Immunocompromised Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Immune Response to Covid 19 Vaccination
• Intervention / Treatment: Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)

Detailed Description

This proposed project is a joint collaboration between the National Research Center(NRC) , Hematology treatment unit of the holding company for biological products and vaccines (VACSERA) and Theodor Bilharz research institute . After a 1 month period of preparation , enrollment will start at month 2 (M2) over a 2 months enrollment window, where persons from 18-70 years old , of both sexes , having their first vaccination dose no more than 3 weeks of any of the available vaccines in Egypt will be enrolled into the project after signing an informed consent . Healthy persons not suffering from any systemic diseases will be enrolled from Theodor Bilharz vaccination center , and the Medical Researches Center of Excellence ( MRCE) at the NRC from the NRC vaccinated staff , while splenectomised B thalassemia patients will be enrolled from the hematology treatment unit at VACSERA . First visit will be performed 3 weeks post the first vaccination dose , while the second visit will be performed 3 weeks post the second vaccination dose , and the third visit will be performed 3 months post the second vaccination dose where ( 5 ) ml of blood will be withdrawn at each visit for the determination of the primary immune response at the first 2 visits and the sustainability of the immune response at the third visit . Enrolled persons will be instructed to contact the project logistics administrator upon experiencing any suspicious symptom of COVID 19 infection ( Fever- loss of taste and/or smell - myalgia - malaise - headache - diarrhea ) who will arrange for an additional visit where a PCR test for COVID 19 will be performed for the determination of breakthrough infections , and if positive this will be considered a primary end point and an additional ( 5) ml of blood will be withdrawn for testing for the immune status .

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mohamed A Mokhles, Professor; Phone Number: +201223407520; Email: mohamad.mokhles@gmail.com
• Study Contact Backup: Name: Reeham H Dawood, Professor; Phone Number: +201004050989; Email: rmhaemd@hotmail.com

Study Locations

• Egypt
  • Dokki
    • Cairo, Dokki, Egypt
      • Recruiting
      • National Research Center
      • Contact: Mohamed A Mokhles, Professor; Phone Number: +201223407520; Email: mohamad.mokhles@gmail.com
      • Contact: Reeham H Dawood, Professor; Phone Number: +201004050989; Email: rmhaemd@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 66 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

1. Both sexes.
2. 3 weeks post scheduled first vaccination dose
3. Healthy group not suffering from any systemic diseases.
4. B thalassemia major splenectomized group
5. Signing an informed consent .

Exclusion Criteria:

1- 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 .

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); Vaccination
Immunocompromised; 100 B thalassemia splenectomised patients.	Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm); Vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
. Determination of the most immunogenic parts of COVID 19 vaccine	Detecting the most immunogenic epitopes located within the spike protein of the vaccines through ELispot assay	Month 3-Month 9 of the study

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Collaborators: Theodor Bilharz Research Institute; The holding company for biological products and vaccines (VACSERA)
• Investigators: Principal Investigator: Mohamed A Mokhles, Professor, National Research Center .

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 03/22-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be shared through published scientific papers that come out of the study , in addition to conferences presentations.
• IPD Sharing Time Frame: AT month 12 of the study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No