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

ArmDescriptionAssigned 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).
  • Biological: Moderna COVID-19 Vaccine
    Sterile liquid for injection. Intervention not administered through this study.
  • Biological: Moderna mRNA1273.222 Booster
    Sterile liquid for injection. Intervention not administered through this study.
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).
  • Biological: Pfizer COVID-19 Vaccine
    Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5).
  • Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
    Sterile liquid for injection. Intervention not administered through this study.
Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5).
  • Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
    Sterile liquid for injection. Intervention not administered through this study.

Recruiting Locations

More Details

NCT ID
NCT05765578
Status
Completed
Sponsor
ModernaTX, Inc.