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

Study Overview
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Brief Summary
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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.

Official Title
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Discoveries - Different Immunization Boosters for Covid-19: Effect on Response in Antibodies

Conditions
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SARS-CoV-2

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: MMM (Moderna Vaccine Series)<br>Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster). | |
| Cohort 2: PPP (Pfizer Vaccine Series)<br>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)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |