Effects of COVID 19 Vaccine on Egyptian Population

• ClinicalTrials.gov Identifier: NCT04809948
• Recruitment Status: Unknown
• First Posted: March 22, 2021
• Last Update Posted: March 24, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Mariam Roshdy Elkhayat, Assiut University

Study Description

Brief Summary:

The aim of this study is to identify adverse events following vaccination by the COVID-19 vaccine by evaluating adverse side effects, hematological values; immunogenicity in the Egyptian candidates in response to COVID-19 vaccine, summarizing the which may occur following administration of COVID-19 vaccine.

Condition or disease	Intervention/treatment
COVID 19 Vaccine	Biological: viral vector vaccine

Detailed Description:

Coronavirus disease 2019 (COVID-19) is an emerging respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that had infected more than 100 million individuals and caused more than 2 million deaths worldwide by February 13, 2021. A safe and effective vaccination trials against COVID-19 is urgently needed. There are currently more than 160 COVID-19 candidate vaccines in development worldwide, and 25 are in different phases of clinical trials using different platforms.

The efficacy and immunogenicity of vaccines varies depending on the study cohort. Race and ethnicity were shown to affect the antibody responses to the rubella vaccine, which elicited significantly higher titers in children of African ethnicity compared to those of European descent or Hispanic ethnicity, likely, disparities in serologic responses to vaccines were also observed between different ethnic groups for the Haemophilus influenzae type b-tetanus toxoid conjugate vaccine , or the Haemophilus influenzae type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine . thus keeping the race an important factor in studding its effect on immunogenicity of vaccine. Thus keeping the race an important factor in studding its effect on immunogenicity of vaccine, which pushed us to estimate immunogenicity in Egyptian population after vaccination with the inactivated COVID-19 vaccine.

Heamatological changes after vaccination had been detected in many researches; lecuocytosis was found shortly after vaccination of infants, which was primarily a neutrophilia but no participant received antibiotics and all remained well at follow-up . In a case series study, also leukocytosis with fever was detected following pneumococcal vaccine administration . On the other hand, neutropenia was detected following a new vaccine against Shigella sonnei . Platelets abnormalities also had been detected following vaccination, a previous example is idiopathic thrombocytopenic purpura, linked to the administration of measles-containing vaccines .

Study Design

• Study Type: Observational
• Estimated Enrollment: 800 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Impact of COVID 19 Vaccine on Safety, Blood Elements, and Immunogenicity of the Egyptian Population
• Estimated Study Start Date: March 2021
• Estimated Primary Completion Date: September 1, 2021
• Estimated Study Completion Date: December 30, 2021

Groups and Cohorts

Intervention Details:

• Biological: viral vector vaccine
  AstraZeneca vaccine

Outcome Measures

Primary Outcome Measures :

1. serological antibodies against SARS-CoV-2 e [ Time Frame: change from baseline at one month after first dose ]
   Total IgG titer
2. serological antibodies against SARS-CoV-2 e [ Time Frame: one month after second dose ]
   Total IgG titer
3. Complete blood count (CBC) [ Time Frame: change from baseline at one month after first dose ]
   to evaluate total leucocyte count TLC
4. Complete blood count (CBC) [ Time Frame: one month after second dose ]
   to evaluate total leucocyte count TLC
5. Complete blood count (CBC) [ Time Frame: change from baseline at one month after first dose ]
   absolute neutrophilic count (ANC)
6. Complete blood count (CBC) [ Time Frame: one month after second dose ]
   absolute neutrophilic count (ANC)
7. Complete blood count (CBC) [ Time Frame: change from baseline at one month after first dose ]
   platelets (PLTs)
8. Complete blood count (CBC) [ Time Frame: one month after second dose ]
   platelets (PLTs)
9. Complete blood count (CBC) [ Time Frame: change from baseline at one month after first dose ]
   hemoglobin level
10. Complete blood count (CBC) [ Time Frame: one month after second dose ]
    hemoglobin level
11. Adverse clinical symptoms after vaccine [ Time Frame: up to one week after first dose ]

    asking about possible recorded side effects as

    • Local: irritation, erythema, swelling, or itching.
    • Systemic: headache, dizziness, difficult sleep, flush, muscle pain, joint pain, fatigue, fever, chills, sore throat, nasal congestion, nasal bleeds, sneezing, runny nose, cough, dyspnoea, palpitation, nausea, vomiting, diarrhoea, constipation, stomach pain, loss of appetite, acute allergic reaction, acne, abnormal taste, loss of taste, mouth ulcers, toothache, ear pain, eye pain, and/or lymphadenopathy.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

HCWs in Assiut University Hospitals accepted to take vaccine

Criteria

Inclusion Criteria:

1. People aged 18-80 years.
2. Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.

Exclusion Criteria:

1. A history of infection with SARS-CoV 3 months before the vaccine.
2. Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
3. Pregnancy.
4. A history of seizures or mental illness.
5. Being on immunosuppressive agents.
6. Being on anticoagulation therapy.
7. Being unable to comply with the study schedule.

Contacts and Locations

Contacts

Contact: Mariam Elkhayat, lecturer; 01003708261; mariam.elkhayat@aun.edu.eg

Contact: Taghreed Meshref, lecturer; 01003651135; tagreed.meshref@aun.edu.eg

Sponsors and Collaborators

Assiut University

More Information

Publications:

Spinelli A, Pellino G. COVID-19 pandemic: perspectives on an unfolding crisis. Br J Surg. 2020 Jun;107(7):785-787. doi: 10.1002/bjs.11627. Epub 2020 Mar 23. No abstract available.

Stern PL. Key steps in vaccine development. Ann Allergy Asthma Immunol. 2020 Jul;125(1):17-27. doi: 10.1016/j.anai.2020.01.025. Epub 2020 Feb 7.

Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543.

Haralambieva IH, Salk HM, Lambert ND, Ovsyannikova IG, Kennedy RB, Warner ND, Pankratz VS, Poland GA. Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014 Apr 7;32(17):1946-53. doi: 10.1016/j.vaccine.2014.01.090. Epub 2014 Feb 13.

Prentice S, Kamushaaga Z, Nash SB, Elliott AM, Dockrell HM, Cose S. Post-immunization leucocytosis and its implications for the management of febrile infants. Vaccine. 2018 May 11;36(20):2870-2875. doi: 10.1016/j.vaccine.2018.03.026. Epub 2018 Apr 11.

von Elten KA, Duran LL, Banks TA, Banks TA, Collins LC, Collins LC. Systemic inflammatory reaction after pneumococcal vaccine: a case series. Hum Vaccin Immunother. 2014;10(6):1767-70. doi: 10.4161/hv.28559. Epub 2014 Mar 18.

Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.

• Responsible Party: Mariam Roshdy Elkhayat, lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT04809948
• Other Study ID Numbers: COVID 19 Vaccine
• First Posted: March 22, 2021
• Last Update Posted: March 24, 2021
• Last Verified: March 2021

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases