Document text
Principal Investigator: Xueying Yang
Organization: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
Fiscal Year: 2022
Award: $255,091
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary/Abstract
Effective and durable COVID-19 vaccines hold the potential to dramatically alter the COVID-19 pandemic.
Remarkable achievement of COVID-19 vaccine development
was observed
in large, randomized-controlled
trials, where several vaccines were found to be safe and efficacious in preventing symptomatic COVID-19.
Despite the high level of vaccine efficacy, a small percentage of fully vaccinated persons (i.e., received all
recommended doses of an FDA-authorized COVID-19 vaccine) will develop symptomatic or asymptomatic
infections of SARS-CoV-2, which is referred to as COVID-19 vaccine breakthrough infections (hereafter as
“breakthrough infections”). Immunocompromised individuals, such as people living with HIV (PLWH), appear
to be at an elevated risk of COVID-related illness, hospitalization, and death. Thus, ensuring the effectiveness
of COVID-19 vaccine in PLWH is pressing. However, the efficacy of COVID-19 vaccine among PLWH remains
unclear because PLWH were not representatively included in the vaccine efficacy trials and did not account for
a large proportion in the existing efforts to investigate vaccine efficacy among immunocompromised
population in the real-world. Understanding COVID-19 vaccine efficacy in real-world settings is critical to
helping disease monitoring and inform future booster vaccine distribution. With NIH support (R01AI127203)
since 2017, we have been utilizing a Big Data approach to examine the treatment gaps among 12,203 PLWH
who were diagnosed with HIV during 2005-2020 (‘HIV Cohort’) in South Carolina (SC). Also supported by
NIH (R01AI127203-04S1), our team have established a South Carolina COVID-19 cohort (S3C) since 06/2020
by integrating patients’ electronic health records (EHR) with one-year pre-COVID healthcare utilization data.
In this exploratory study, we will retrieve the patient-level immunization records from the South Carolina
Statewide Immunization Online Network (SIMON) and merge this database with ‘HIV Cohort’ database to
identify vaccinated PLWH and a comparison group of non-PLWH via propensity score matching. The S3C
cohort data, which includes healthcare encounters and COVID-19 diagnosis information, will be merged with
HIV Cohort and SIMON datasets to define the breakthrough infections. With the integration of multiple data
sources and advanced data analytics, the current exploratory study first aims to characterize and compare the
breakthrough infections (e.g., prevalence and disease severity) between PLWH and non-PLWH and then
examine whether HIV markers and HIV treatment play a role in COVID-19 vaccine efficacy within the PLWH
population while adjusting for key confounders (e.g., prior COVID-19 diagnosis, comorbid conditions, local
COVID-19 incidence). The proposed research is innovative and significant because understanding the COVID-
19 vaccine efficacy among PLWH and non-PLWH is essential to support informed vaccination decision-making
in clinical practice. Characterizing PLWH at higher risk of breakthrough infections (low CD4 counts,
unsuppressed viral load) may help to develop guidance to augment their protection against risk of COVID-19.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><65+ years old><AIDS><AIDS Virus><Achievement><Achievement Attainment><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immuno-Deficiency Syndrome><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Acquired Immunologic Deficiency Syndrome><Affect><Aged 65 and Over><Antibodies><Big Data><BigData><CD4 Cells><CD4 Lymphocyte Count><CD4 Positive T Lymphocytes><CD4 T cells><CD4 helper T cell><CD4 lymphocyte><CD4+ Cell Counts><CD4+ Counts><CD4+ T-Lymphocyte><CD4-Positive Lymphocytes><CDC><COVID><COVID crisis><COVID epidemic><COVID pandemic><COVID-19><COVID-19 antibody><COVID-19 crisis><COVID-19 diagnosis><COVID-19 epidemic><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 infection><COVID-19 outbreak><COVID-19 pandemic><COVID-19 public health crisis><COVID-19 related risk><COVID-19 risk><COVID-19 risk factor><COVID-19 vaccination><COVID-19 vaccine><COVID-19 virus><COVID19><COVID19 crisis><COVID19 diagnosis><COVID19 epidemic><COVID19 global health crisis><COVID19 global pandemic><COVID19 health crisis><COVID19 infection><COVID19 outbreak><COVID19 pandemic><COVID19 public health crisis><COVID19 vaccination><COVID19 vaccine><COVID19 virus><CV-19><CV19><Case Series><Case Study><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Cessation of life><Clinical><Clinical Management><CoV disease><CoV-2><CoV2><Data><Data Analytics><Data Bases><Data Set><Databases><Dataset><Death><Decision Making><Diagnosis><Disease><Disorder><Dose><Effectiveness><Electronic Health Record><Ensure><Female><Funding><Future><Guidelines><HIV><Health Care Utilization><Healthcare><Hospital Admission><Hospitalization><Human Immunodeficiency Viruses><Immune response><Immunization><Immunocompromised><Immunocompromised Host><Immunocompromised Patient><Immunologic Sensitization><Immunologic Stimulation><Immunological Sensitization><Immunological Stimulation><Immunological response><Immunostimulation><Immunosuppressed Host><Immunosuppression><Immunosuppression Effect><Immunosuppressive Effect><Incidence><Individual><Infection><LAV-HTLV-III><Lead><Lymphadenopathy-Associated Virus><Measures><Medical><Monitor><Morbidity><Morbidity - disease rate><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Patients><Pb element><Persons><Phase><Play><Population><Predisposition><Prevalence><Preventative measure><Preventive measure><Randomized Controlled Trials><Records><Reporting><Research><Risk><Role><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 antibody><SARS-CoV-2 diagnosis><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 infection><SARS-CoV-2 outbreak><SARS-CoV-2 pandemic><SARS-CoV-2 vaccination><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 antibody><SARS-CoV2 epidemic><SARS-CoV2 infection><SARS-CoV2 outbreak><SARS-CoV2 pandemic><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sample Size><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 outbreak><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 vaccination><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Severity of illness><Social Distance><Societies><South Carolina><Susceptibility><T-Cell Depletion><T-cell depletion therapy><T-lymphocyte depletion therapy><T4 Cells><T4 Lymphocyte Count><T4 Lymphocytes><Time><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><United States National Institutes of Health><Update><Vaccination><Vaccinee><Vaccines><Variant><Variation><Viral><Viral Burden><Viral Load><Viral Load result><Virus-HIV><Vulnerable Populations><Wuhan coronavirus><acquired immunodeficiency><age 65 and greater><age 65 and older><aged 65 and greater><aged ≥65><anti-retroviral therapy><anti-retroviral treatment><antibody against COVID-19><antibody against SARS-CoV-2><antibody against SARS-CoV2><antibody against coronavirus disease 2019><antibody against severe acute respiratory syndrome coronavirus 2><antibody to COVID-19><antibody to SARS-CoV-2><antibody to SARS-CoV2><antibody to coronavirus disease 2019><antibody to severe acute respiratory syndrome coronavirus 2><antiretroviral therapy><antiretroviral treatment><booster dose><booster shot><booster vaccine><breakthrough infection><case report><clinical practice><co-morbid><co-morbidity><cohort><comorbidity><comparator group><comparison group><corona virus disease><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><corona virus disease 2019 vaccine><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 antibody><coronavirus disease 2019 crisis><coronavirus disease 2019 diagnosis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 infection><coronavirus disease 2019 outbreak><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease 2019 risk><coronavirus disease 2019 risk factor><coronavirus disease 2019 vaccination><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19><coronavirus disease-19 global pandemic><coronavirus disease-19 outbreak><coronavirus disease-19 pandemic><coronavirus disease-19 vaccine><coronavirus disease-19 virus><coronavirus infectious disease-19><data base><deploy vaccines><develop a vaccine><develop vaccines><development of a vaccine><diagnosed with COVID-19><diagnosed with COVID19><diagnosed with SARS-CoV-2><diagnosed with coronavirus 2019><diagnosed with coronavirus disease 2019><disease severity><distribute vaccines><efficacy trial><electronic health care record><electronic healthcare record><experience><hCoV19><health care><health care service use><health care service utilization><health equity promotion><healthcare service use><healthcare service utilization><healthcare utilization><heavy metal Pb><heavy metal lead><high risk><host response><human old age (65+)><immune suppression><immune suppressive activity><immune suppressive function><immune system response><immunoresponse><immunosuppressed patient><immunosuppressive activity><immunosuppressive function><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><innovate><innovation><innovative><mortality><multiple data sources><nCoV2><neutralizing antibody><old age><post-COVID><post-COVID-19><post-coronavirus disease 2019><prevent><preventing><promote health equity><protective effect><randomized control trial><response><risk associated with COVID-19><risk factor associated with COVID-19><risk factor related to COVID-19><risk related to COVID-19><severe acute respiratory syndrome coronavirus 2 antibody><severe acute respiratory syndrome coronavirus 2 diagnosis><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><social role><surveillance data><symptomatic COVID-19><symptomatic COVID19><symptomatic coronavirus disease 2019><vaccinate against COVID-19><vaccinate against COVID19><vaccinate against SARS-CoV-2><vaccinate against coronavirus disease 2019><vaccinate against severe acute respiratory syndrome coronavirus 2><vaccinated individual><vaccinated participant><vaccinated patient><vaccinated person><vaccinated subject><vaccination against COVID-19><vaccination against COVID19><vaccination against SARS-CoV-2><vaccination against Severe acute respiratory syndrome coronavirus 2><vaccination against coronavirus disease 2019><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine deployment><vaccine development><vaccine distribution><vaccine efficacy><vaccine for novel coronavirus><vaccine roll-out><vaccine rollout><vulnerable group><vulnerable people>