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

NCT05392075 | Completed

• 1 other identifier: 014.IMD.2022.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pneumonia; COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence rate of COVID-19 breakthrough infections in fully vaccinated

  The number of COVID-19 breakthrough infections in fully vaccinated participants

  up to 6 months

• incidence rate of COVID-19 breakthrough infections in fully vaccinated subjects who received a COVID-19 booster vaccine different form their initial two doses (for a mRNA vaccine) or the single-dose Janssen COVID-19 vaccine.

  Comparison of the number of COVID-19 breakthrough infections in fully vaccinated subject who received a COVID-19 booster

  up to 6 months

Study Arms (1)

COVID-19 diagnosis

The study will enroll all subjects who received care at Methodist Dallas Medical Center between August 1, 2021 and February 28, 2022, and were diagnosed with COVID-19. COVID-19 diagnosis for the purpose of this study is either a positive COVID-19 antigen or a positive COVID-19 PCR test.

Biological: Pfizer COVID-19 mRNA vaccine; Biological: Moderna COVID-19 mRNA vaccine

Interventions

Pfizer COVID-19 mRNA vaccine BIOLOGICAL

vaccinated people who received the Pfizer COVID-19 mRNA vaccine

COVID-19 diagnosis

Moderna COVID-19 mRNA vaccine BIOLOGICAL

vaccinated people who received the Moderna COVID-19 mRNA vaccine vaccine

COVID-19 diagnosis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects who received care at Methodist Dallas Medical Center between August 1, 2021 and February 28, 2022, and were diagnosed with COVID-19.

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:

• The patient had a COVID-19 infection diagnosed at a non-Methodist facility within the last 30 days.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

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

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Valentine Ebuh, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 26, 2022
• Study Start: March 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: August 17, 2023
• Last Updated: March 24, 2026

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)