Effects of COVID 19 Vaccine on Egyptian Population

NCT04809948 | Unknown

• 1 other identifier: COVID 19 Vaccine
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID 19 Vaccine

Outcome Measures

Primary Outcomes (11)

• serological antibodies against SARS-CoV-2 e

  Total IgG titer

  change from baseline at one month after first dose

• serological antibodies against SARS-CoV-2 e

  Total IgG titer

  one month after second dose

• Complete blood count (CBC)

  to evaluate total leucocyte count TLC

  change from baseline at one month after first dose

• Complete blood count (CBC)

  to evaluate total leucocyte count TLC

  one month after second dose

• Complete blood count (CBC)

  absolute neutrophilic count (ANC)

  change from baseline at one month after first dose

• Complete blood count (CBC)

  absolute neutrophilic count (ANC)

  one month after second dose

• Complete blood count (CBC)

  platelets (PLTs)

  change from baseline at one month after first dose

• Complete blood count (CBC)

  platelets (PLTs)

  one month after second dose

• Complete blood count (CBC)

  hemoglobin level

  change from baseline at one month after first dose

• Complete blood count (CBC)

  hemoglobin level

  one month after second dose

• Adverse clinical symptoms after vaccine

  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.

  up to one week after first dose

Interventions

viral vector vaccine BIOLOGICAL

AstraZeneca vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCWs in Assiut University Hospitals accepted to take vaccine

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 32191340 BACKGROUND

• 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.

  PMID: 32044451 BACKGROUND

• 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.

  PMID: 32789505 BACKGROUND

• 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.

  PMID: 24530932 BACKGROUND

• 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.

  PMID: 29655624 BACKGROUND

• 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.

  PMID: 24642659 BACKGROUND

• 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.

  PMID: 27490698 BACKGROUND

Central Study Contacts

Mariam Elkhayat, lecturer

CONTACT

01003708261; mariam.elkhayat@aun.edu.eg

Taghreed Meshref, lecturer

CONTACT

01003651135; tagreed.meshref@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 22, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 30, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03