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)

Moderna

Status: Completed

Conditions: COVID-19

Treatments: Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5); Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5); Biological: Pfizer COVID-19 Vaccine; Biological: Moderna mRNA1273.222 Booster; Biological: Moderna COVID-19 Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT05765578

mRNA-1273-P922

Details and patient eligibility

About

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).

Enrollment: 1,713 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,713 participants in 4 patient groups

Moderna-Only Vaccine/Booster Series (MMMM Group)

Description:

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).

Treatment:

Biological: Moderna COVID-19 Vaccine

Biological: Moderna mRNA1273.222 Booster

Pfizer-Only Vaccine/Booster Series (PPPP Group)

Description:

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).

Treatment:

Biological: Pfizer COVID-19 Vaccine

Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group

Description:

Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5).

Treatment:

Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)

Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group

Description:

Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5).

Treatment:

Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)