A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Purpose
The goal of this study is to compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Fully vaccinated with a currently US authorized COVID-19 vaccine: - 2 doses of mRNA-1273 (minimum 14 days between doses) - 2 doses of BNT1262b2 (minimum 14 days between doses) - Continuous enrollment in medical & pharmacy plan for at least 365 days prior to index/Cohort entry date (CED) - Identified as immunocompromised via at least 1 of the following criteria at index/CED - Evidence of blood or stem cell transplant in 2 years prior to index/CED - Any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/CED - Evidence of active cancer treatment in the 180 days prior to index/CED with an active cancer diagnosis in the 365 days prior to treatment - Any prior history of a primary immunodeficiency disorder (for example, for conditions such as DiGeorge syndrome and Wiskott-Aldrich syndrome) - Any history of an HIV diagnosis code prior to index/CED - A fill for an immunosuppressive therapy in the 60 days prior to index/CED
Exclusion Criteria
- Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim: - U07.1: "COVID-19, virus identified" - J12.82: "Pneumonia due to COVID-19" - Z86.16: "Personal history of COVID-19" - The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen: - J12.89: "Other viral pneumonia" - J20.8: "Acute bronchitis due to other specified organisms" - J40: "Bronchitis, not specified as acute or chronic" - J22: "Unspecified acute lower respiratory infection" - J98.8: "Other specified respiratory disorders" - J80: "Acute respiratory distress syndrome" - Prior receipt of a heterologous COVID-19 vaccine (relative to the COVID-19 vaccine identified at index/CED) in the 365 days prior to index/CED through 13 days post-completion of vaccine regimen - Receipt of an additional dose of homologous COVID-19 vaccine between index/CED and 13 days post-completion of vaccine regimen - Missing or unknown gender on index/CED
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort A: mRNA-1273 COVID Vaccine | Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart. | |
| Cohort B: BNT1262b2 COVID Vaccine | Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart. |
Recruiting Locations
More Details
- NCT ID
- NCT05366322
- Status
- Completed
- Sponsor
- ModernaTX, Inc.
Detailed Description
This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.