A Study to Determine Antibody Levels After Receiving COVID-19 Boosters of Any Kind

Completed

• Conditions: SARS-CoV-2

• Registration Number: NCT05367908
• Lead Sponsor: ModernaTX, Inc.

Brief Summary

This study will investigate antibody levels with respect to time since receiving a COVID-19 booster shot. The study will be decentralized, where participants can complete all study tasks at home. Self-reported participant information will be collected via surveys conducted at intake and monthly throughout the study. Participants will also perform monthly at-home capillary blood draws via YourBio devices that will be mailed to the designated laboratory for sample processing and antibody testing.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Primary Completion: 2022-08-14
• Study Completion: 2022-08-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1501

Inclusion Criteria

• Lives in the continental United States.
• Has been vaccinated against COVID-19 with a U.S.-authorized vaccine (that is, received the single shot J&J vaccine or both shots in the Pfizer or Moderna series).
• Has received a COVID-19 booster between September 2021 and screening.
• Is willing and able to submit vaccination card photo(s).
• Is willing and able to self-collect capillary blood 3 times during the study period via an at-home whole-blood collection device (that is, the YourBio TAP II Device).

Exclusion Criteria

• Has been diagnosed with significant cognitive impairment or dementia.
• Has received more than one COVID-19 vaccine booster at screening.
• 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 or is taking medications for rheumatoid arthritis (RA), lupus or multiple sclerosis (MS).
• 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
Change in Antibody Levels Since Receiving a COVID-19 Booster Vaccine at 0, 1, and 2 Months Post Enrollment	Baseline (Month 0), Month 1, and Month 2

Trial Locations

Locations (1)

Evidation Health; 🇺🇸 San Mateo, California, United States