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)
Purpose
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).
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Moderna-Only Vaccine/Booster Series (MMMM Group) | Individuals who previously received Moderna COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Moderna mRNA1273.222). |
|
Pfizer-Only Vaccine/Booster Series (PPPP Group) | Individuals who previously received Pfizer COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Pfizer-BNT 162b2 bivalent booster). |
|
Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group | Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5). |
|
Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group | Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5). |
|
Recruiting Locations
More Details
- NCT ID
- NCT05765578
- Status
- Completed
- Sponsor
- ModernaTX, Inc.