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

Moderna

Status: Completed

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT05367908

mRNA-1273-P914

Details and patient eligibility

About

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.

Enrollment: 1,501 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,501 participants in 3 patient groups

Cohort 1: MMM (Moderna Vaccine Series)

Description:

Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster).

Cohort 2: PPP (Pfizer Vaccine Series)

Description:

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)

Description:

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.