An Observational Study of Moderna COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)

Completed

• Conditions: COVID-19

• Registration Number: NCT05765578
• Lead Sponsor: ModernaTX, Inc.

Brief Summary

The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-08
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-13
• Primary Completion: 2024-06-17
• Study Completion: 2024-06-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1713

Inclusion Criteria

• Lives in the continental United States (US).
• Speaks, reads, and understands English.
• Is willing and able to submit vaccination card photo(s) or vaccination records.
• Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
• Is fully vaccinated against COVID-19 per protocol specified criteria.

Exclusion Criteria

• Has been diagnosed with significant cognitive impairment or dementia.
• Is pregnant or planning to become pregnant during the study period.
• Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
• Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
• Is currently participating in a COVID-19 vaccine clinical trial.
• Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.
• Is currently taking steroids, such as prednisone, for any condition.
• Has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis.
• Has received an organ transplant.
• Is currently undergoing dialysis of any kind (for example, hemodialysis or chronic ambulatory dialysis) for kidney disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group	Day 91
Geometric Mean Ratio (GMR) of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 29 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)	Day 29
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 91 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)	Day 91
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group	Day 29
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group	Day 181
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 181 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)	Day 181

Secondary Outcome Measures

Name	Time	Method
GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group	Day 29, Day 91, and Day 181
GMR of GMT Against All Other Omicron Variants and Subvariants Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)	Day 29, Day 91, and Day 181

Trial Locations

Locations (1)

Science37; 🇺🇸 Culver City, California, United States