A Study to Determine Antibody Levels After Receiving COVID-19 Boosters of Any Kind
Purpose
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.
Condition
- SARS-CoV-2
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Cohort 1: MMM (Moderna Vaccine Series) | Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster). | |
Cohort 2: PPP (Pfizer Vaccine Series) | Participants who have only received Pfizer COVID-19 vaccines (that is, the 2-shot series and a booster). | |
Cohort 3: V (Other Combination of Vaccines) | Participants who have received any other combinations of boosters authorized in the United States, such as the 2-shot Pfizer series and a Moderna booster (PPM), the 2-shot Moderna series and a Pfizer booster (MMP), or the 1-shot Johnson and Johnson vaccine with either a Moderna or Pfizer booster. |
Recruiting Locations
More Details
- NCT ID
- NCT05367908
- Status
- Completed
- Sponsor
- ModernaTX, Inc.