COVID-19
Conditions
Keywords
Immunogenicity, Moderna, mRNA-1273, Omicron, Vaccines
Brief summary
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).
Interventions
BIOLOGICALModerna COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
BIOLOGICALModerna mRNA1273.222 Booster
Sterile liquid for injection. Intervention not administered through this study.
BIOLOGICALPfizer COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
BIOLOGICALModerna 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
BIOLOGICALPfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Sponsors
ModernaTX, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 181 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) | Day 181 |
| Geometric Mean Ratio (GMR) of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 29 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) | Day 29 |
| GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 91 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) | Day 91 |
| Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group | Day 29 |
| GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group | Day 91 |
| GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group | Day 181 |
Secondary
| Measure | Time frame |
|---|---|
| GMR of GMT Against All Other Omicron Variants and Subvariants Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) | Day 29, Day 91, and Day 181 |
| GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group | Day 29, Day 91, and Day 181 |
Countries
United States
Outcome results
None listed