Covid-19 Infection in After Vaccination
- Conditions
- Covid19
- Interventions
- Other: covid-19 vaccines registered in Egypt
- Registration Number
- NCT05033834
- Lead Sponsor
- Assiut University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
-
• 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).
• Children less than 18 years.
- Cases non vaccinated with COVID-19 registered vaccine
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group B covid-19 vaccines registered in Egypt People developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine Group A covid-19 vaccines registered in Egypt People received any registered COVID-19 vaccination
- Primary Outcome Measures
Name Time Method assess the prevalence of COVID-19 infection after vaccination one year number of cases with covid-19 after vaccination
- Secondary Outcome Measures
Name Time Method evaluate the severity of infection after vaccination 2 weeks severity of covid-19 infection in partially and fully vaccinated cases
Predict possible risk factors of post vaccination infection one year adherence to protective measures
Trial Locations
- Locations (3)
AssiutU
🇪🇬Assiut, Egypt
Pulmonology Departments
🇪🇬Assiut, Egypt
Aliae AR Mohamed-Hussein
🇪🇬Assiut, Egypt