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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05392075
Recruitment Status : Enrolling by invitation
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

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.

Condition or disease Intervention/treatment
COVID-19 Pneumonia COVID-19 Biological: Pfizer COVID-19 mRNA vaccine Biological: Moderna COVID-19 mRNA vaccine

Detailed Description:

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.

Similar to other infections that are preventable with vaccination, COVID-19 vaccination is not a SARS-CoV-2 infection panacea. However, in fully vaccinated people the risk of SARS-CoV-2 infection, hospitalization, severe illness, and death from COVID-19 is relatively less. Viruses may escape the host immune defense through mutations that create new variants of the primary virus. Some variants emerge and disappear while others persist and may have properties that may be different from the primary virus. By late 2020, a new variant, the delta variant, was identified in Maharashtra, India. This variant is highly transmissible and causes infections even in fully vaccinated people, it is less sensitive to neutralizing antibodies from recovered subjects and less sensitive to vaccine-induced antibodies, and there is evidence that it causes more severe infections. While the world was trying to contain and control the spread of the delta variant, the WHO reported a new variant of COVID-19, omicron. It was detected in late November 2021 in specimens collected in Botswana and South Africa. New variants of SARS-CoV-2 are expected to continue to emerge and the world continues to seek means of controlling the pandemic.

COVID-19 vaccination data from the Centers for Disease Control and Prevention (CDC) showed that the population ratios who have received a full series of COVID-19 vaccination from Pfizer, Moderna, or Janssen as of February 2, 2022 is 17.46/11.25/1. Furthermore, more of those who received the Janssen COVID-19 viral vector vaccine have preferred and received an mRNA vaccine booster. Unfortunately, the CDC data lacks the booster dose data for Texas residents.

The FDA in collaboration with the CDC makes decision on when a booster is recommended. This decision is based on many factors including the level of antibodies and memory cells post-COVID-19 vaccination and infection. There is much evidence that decreasing the COVID-19 spike antibodies titer and memory cells may increase the likelihood of a breakthrough COVID-19 infection. Unfortunately, there isn't a prior report or study comparing the incidence of COVID-19 infection among people fully vaccinated with any of the approved COVID-19 vaccines. This study seeks to find a relationship between the last dose of a COVID-19 vaccine in a fully vaccinated person and a COVID-19 breakthrough infection. The study will also find a correlation between the duration from a booster dose to the diagnosis of a breakthrough COVID-19 infection.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19 Breakthrough Infection in Fully Vaccinated People and in People Who Received a Booster Dose
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : March 15, 2023
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
vaccinated people who received the Pfizer COVID-19 mRNA vaccine

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




Primary Outcome Measures :
  1. Incidence rate of COVID-19 breakthrough infections in fully vaccinated [ Time Frame: up to 6 months ]
    The number of COVID-19 breakthrough infections in fully vaccinated participants

  2. 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. [ Time Frame: up to 6 months ]
    Comparison of the number of COVID-19 breakthrough infections in fully vaccinated subject who received a COVID-19 booster



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05392075


Locations
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United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Valentine Ebuh, MD Methodist Health System
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT05392075    
Other Study ID Numbers: 014.IMD.2022.D
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs