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

SARS-CoV-2 Clinical Trial

Official title:

Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366322
• Other study ID #: mRNA-1273-P913
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: March 21, 2022

Study information

• Verified date: April 2022
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124879
• Est. completion date: March 21, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Locations

Country	Name	City	State
United States	Aetion Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis	Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.).	Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
Secondary	Number of Participants with Breakthrough Hospitalization for COVID-19	Breakthrough hospitalization for COVID-19 defined as a hospital stay for COVID-19 listed as the primary diagnosis or within 21 days prior to hospital admission.	Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])