COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States

Study Overview
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Brief Summary
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This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.

Detailed Description
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The objective of this US-based retrospective cohort study is to evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination. Subjects will be aged 12 years and older and will have no evidence of prior SARS-CoV-2 infection. The primary analysis will be conducted on subjects vaccinated with BNT162b2. A variety of subgroup analyses and sensitivity analyses are planned.

Official Title
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Coronavirus Disease 2019 (COVID-19) Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States

Conditions
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Immunocompromised, Immunosuppressed, Covid-19, SARS-COV-2, SARS-COV-2 Infection, Breakthrough Infection

Intervention / Treatment
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* Biological: BNT162b2 (Tozinameran)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Unique enrollees in the HealthVerity Vaccine dataset anytime after December 10, 2020 At least 12 years on the index date (ie, first vaccination date) No evidence of prior COVID-19 infection (a medical claim, pharmacy claim, or chargemaster record with a diagnosis code of ICD-10-CM U07.1) in the 12 months prior to the index date Have 12 months of continuous enrollment with medical benefits (with or without pharmacy benefits) prior to the index date. Subjects with an IC condition will be identified via an algorithm developed for use in administrative claims database studies. Exclusion criteria: subjects not meeting the criteria above will be excluded.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunocompromised<br>Vaccinated Subject with 1 or >1 immunocompromising conditions. | Biological: BNT162b2 (Tozinameran)<br>* Covid-19 Vaccine<br>* Other names: Pfizer-BioNTech COVID-19 vaccine;|
| Non-Immunocompromised<br>Vaccinated subjects without evidence of immunocompromising condition. | Biological: BNT162b2 (Tozinameran)<br>* Covid-19 Vaccine<br>* Other names: Pfizer-BioNTech COVID-19 vaccine;|
| Total Population (immunocompromised and non)<br>Vaccinated Subjects with or without 1 or >1 immunocompromising conditions. | Biological: BNT162b2 (Tozinameran)<br>* Covid-19 Vaccine<br>* Other names: Pfizer-BioNTech COVID-19 vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Breakthrough SARS-CoV-2 Infection | Among subjects who meet the definition of fully vaccinated, a breakthrough SARS-CoV-2 infection will be defined by evidence of a claim with a diagnosis code of U07.1 that occurs >14 days after the second vaccination date. Incidence rates will be calculated as the number of breakthrough infections divided by the time at risk. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Time to Breakthrough SARS-CoV-2 Infection | Days from the completion of vaccination to the first occurrence of a Breakthrough SARS-CoV-2 Infection. | From completion of vaccination through the end of the study period, up to approximately one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient Hospital Visit | Number of outpatient hospital visits due to SARS-CoV-2. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Emergency Hospital Visit | Number of emergency hospital visits due to SARS-CoV-2. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Other Outpatient Visit (Non- Emergency, Not Hospital based) | Number of other outpatient encounters due to SARS-CoV-2 (excluding emergency hospital visits and outpatient hospital visits). | From completion of vaccination through the end of the study period, up to approximately one year | 
| Hospitalization | Number of subjects hospitalized due to SARS-CoV-2. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Intensive Care Unit | Number of admissions to the Intensive Care Unit due to SARS-CoV-2. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Invasive Mechanical Ventilation/ECMO | Number of subjects requiring Invasive Mechanical Ventilation/ECMO (Extracorporeal membrane oxygenation) due to SARS-CoV-2. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Inpatient Death | Number of deaths that occur during a hospitalization due to SARS-CoV-2 infection. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Length of Stay (LOS) | Days from admission in hospital to discharge. | From completion of vaccination through the end of the study period, up to approximately one year | 
| Total Costs | Non-zero costs associated with any of the previously listed Outpatient and Inpatient encounters (but death). Costs will be measured in USD. | From completion of vaccination through the end of the study period, up to approximately one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunocompromised, Immunosuppressed, Immunosuppressive drugs, Covid-19, Covid-19 Vaccination, mRNA Vaccine, SARS-CoV-2 Vaccine, BNT162b2, Breakthrough Infection, SARS-COV-2 Infection, SARS-COV-2