COVID-19 Breakthrough Infection in Fully Vaccinated People and in People Who Received a Booster Dose

Completed

Conditions studied: COVID-19 Pneumonia, COVID-19

In brief

A novel coronavirus, SARS-CoV-2 (formerly known as the 2019 novel coronavirus \[2019-nCoV\]) was identified as the agent that caused an outbreak of pneumonia (termed COVID-19) in Wuhan, China in December 2019. The virus quickly spread to other countries and on March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. By March 2021, many nations and organizations embarked on finding a cure or vaccine for this devastating viral infection. The Pfizer COVID-19 mRNA vaccine was the first to obtain emergency use authorization (EUA) from the Food \& Drug Administration (FDA) on December 11, 2020, followed by the Moderna COVID-19 mRNA vaccine on December 18, 2020, and the Janssen COVID-19 viral vector vaccine on February 27, 2021. The mRNA vaccines and the viral vector vaccine are designed based on the spike protein of SARS-COV-2. These vaccines had been administered to millions of Americans prior to July 2021.

Key facts

Study ID

NCT05392075

Run by

Methodist Health System

People needed

100

Starts

2023-03-15

Expected to finish

2023-08-17

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be male or female, ≥18 years of age
• Be willing and able to provide informed consent if needed; in cases where an abbreviated telephone informed consent needs to be obtained, the patient must understand and speak English.
• Has received at least two doses of an mRNA vaccine or one dose of the Janssen COVID-19 vaccine
• Had a positive COVID-19 antigen or PCR test at least 14 days after the last COVID-19 vaccine.
• Patients who had a diagnosis of COVID-19 at a Methodist Facility within the last 30 days preceding their admission must have the result in their electronic medical record.

You may not qualify if…

• Does not satisfy all of the inclusion criteria.
• The patient had a COVID-19 infection diagnosed at a non-Methodist facility within the last 30 days.

Where it is running

• Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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