Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05392075 |
| Other study ID # |
014.IMD.2022.D |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2023 |
| Est. completion date |
August 17, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
