Covid-19 Infection in After Vaccination

Study Overview
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Brief Summary
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Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Globally, till 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO. With the absence of curative treatment for COVID-19 infection the development of safe and effective vaccines is critical to ending the COVID-19 pandemic. The Pfizer/BioNtech Comirnaty vaccine was listed for WHO Emergency Use Listing (EUL) on 31 December 2020. The SII/Covishield and AstraZeneca/AZD1222 vaccines (developed by AstraZeneca/Oxford and manufactured by the State Institute of India and SK Bio respectively) were given EUL on 16 February. The Janssen/Ad26.COV 2.S developed by Johnson & Johnson, was listed for EUL on 12 March 2021. The Moderna COVID-19 vaccine (mRNA 1273) was listed for EUL on 30 April 2021 and the Sinopharm COVID-19 vaccine was listed for EUL on 7 May 2021. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). The Sinovac-CoronaVac was listed for EUL on 1 June 2021. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered. In large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19. However, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.

Official Title
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Covid-19 Infection in Partially and Fully Vaccinated Cases: Cohort Study

Conditions
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Covid19

Intervention / Treatment
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* Other: covid-19 vaccines registered in Egypt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients 18 years old and above of both genders. Received at least one dose of COVID-19 registered vaccines. Diagnosed COVID-19 positive after vaccination by real time PCR (confirmed case) or combined clinical and radiological diagnosis (possible case). Exclusion Criteria: • Children less than 18 years. Cases non vaccinated with COVID-19 registered vaccine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>People received any registered COVID-19 vaccination | Other: covid-19 vaccines registered in Egypt<br>* Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine<br>|
| Group B<br>People developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine | Other: covid-19 vaccines registered in Egypt<br>* Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the prevalence of COVID-19 infection after vaccination | number of cases with covid-19 after vaccination | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the severity of infection after vaccination | severity of covid-19 infection in partially and fully vaccinated cases | 2 weeks | 
| Predict possible risk factors of post vaccination infection | adherence to protective measures | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, COVID-19 vaccination, Post vaccination infection, breakthrough COVID-19, Partially vaccinated, Fully vaccinated