Covid-19 Infection in After Vaccination

NCT05033834 | Unknown

• 1 other identifier: Assiut-breakthrough covid-19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Keywords

COVID-19; COVID-19 vaccination; Post vaccination infection; breakthrough COVID-19; Partially vaccinated; Fully vaccinated

Outcome Measures

Primary Outcomes (1)

• assess the prevalence of COVID-19 infection after vaccination

  number of cases with covid-19 after vaccination

  one year

Secondary Outcomes (2)

• evaluate the severity of infection after vaccination

  2 weeks

• Predict possible risk factors of post vaccination infection

  one year

Study Arms (2)

Group A

People received any registered COVID-19 vaccination

Other: covid-19 vaccines registered in Egypt

Group B

People developed COVID-19 infection after partial or full vaccination with any registered COVID-19 vaccine

Other: covid-19 vaccines registered in Egypt

Interventions

covid-19 vaccines registered in Egypt OTHER

Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine

Group A; Group B

Eligibility Criteria

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

Study Population

Group A: people receive vaccination at the study period will be followed by phone calls or email for any new infection. Group B: patients who will be confirmed to have recent COVID-19 infection who visit outpatient clinic or admit to ward or ICU of Assiut University hospital at study period.

You may qualify if:

• 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).

You may not qualify if:

• Children less than 18 years.
• Cases non vaccinated with COVID-19 registered vaccine

Sponsors & Collaborators

• Assiut University: lead

Study Sites (3)

AssiutU

Asyut, 71111, Egypt

Location

Pulmonology Departments

Asyut, 71111, Egypt

Location

Aliae AR Mohamed-Hussein

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

COVID-19; COVID-19 breakthrough infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonology

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Locations

EG (3)