An effective vaccine stands as the most effective way for controlling the COVID 19pandemic , yet, immunogenic vaccine efficacy needs to be extensively studied . T cellresponses against the structural proteins have been found to be the most immunogenic inperipheral blood mononuclear cells of convalescent SARS-CoV1 patients which needs to betested in SARS -COV2 vaccine efficacy studies alongside with the sustainability ofhumoral and cellular immune responses . Clinically , immunocompromised patients facedrastic outcome of infections , which led the Advisory Committee on ImmunizationPractices (ACIP) - USA -and the Joint Committee on Vaccination and Immunisation (JCVI)-UK- recommend COVID-19 vaccination of immunocompromised , the WHO Strategic AdvisoryGroup 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 towardsCOVID 19 vaccination in this population .Based on the previous work of our team in designing B and T cell epitopes distributedover the S protein , we will study the immune response in the available vaccines inEgypt.
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ml of blood will be withdrawn at each visit for the determination of the primary immune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 .
Biological: Covid vaccines (Moderna - Pfizer- Astra Zeneca- Johnson and Johnson - Sinopahrm)
Vaccination
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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National Research Center
Cairo, Dokki, Egypt
Investigator: Mohamed A Mokhles, Professor
Contact: +201223407520
mohamad.mokhles@gmail.com
Mohamed A Mokhles, Professor
+201223407520
mohamad.mokhles@gmail.com
Reeham H Dawood, Professor
+201004050989
rmhaemd@hotmail.com
Mohamed A Mokhles, Professor, Principal Investigator
National Research Center .