A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults

NCT ID: NCT05366322

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124879 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-03-21

Brief Summary

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.

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.

Conditions

SARS-CoV-2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort A: mRNA-1273 COVID Vaccine

Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart.

No interventions assigned to this group

Cohort B: BNT1262b2 COVID Vaccine

Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aetion Inc.

New York, New York, United States

Countries

United States

References

Mues KE, Kirk B, Patel DA, Gelman A, Chavers LS, Talarico CA, Esposito DB, Martin D, Mansi J, Chen X, Gatto NM, Van de Velde N. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States. Vaccine. 2022 Nov 8;40(47):6730-6739. doi: 10.1016/j.vaccine.2022.09.025. Epub 2022 Sep 24.

Reference Type: DERIVED

PMID: 36163093 (View on PubMed)

Other Identifiers

mRNA-1273-P913

Identifier Type: -

Identifier Source: org_study_id