Clinical trial
DisCOVEries 2 - An Observational Study to Evaluate the Immunogenicity of mRNA COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)
Name
mRNA-1273-P922
Description
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).
Trial arms
Trial start
2023-03-08
Estimated PCD
2024-06-30
Trial end
2024-12-31
Status
Active (not recruiting)
Treatment
Moderna COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Arms:
Moderna-Only Vaccine/Booster Series (MMMM Group)
Moderna mRNA1273.222 Booster
Sterile liquid for injection. Intervention not administered through this study.
Arms:
Moderna-Only Vaccine/Booster Series (MMMM Group)
Pfizer COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Arms:
Pfizer-Only Vaccine/Booster Series (PPPP Group)
Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Arms:
Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group
Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Arms:
Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group
Size
1704
Primary endpoint
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
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
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
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Serum from blood samples will be used for binding antibody testing.'}, 'enrollmentInfo': {'count': 1704, 'type': 'ACTUAL'}}
Updated at
2023-12-22
1 organization
5 products
1 indication
Organization
ModernaTXProduct
Moderna COVID-19 VaccineIndication
COVID-19Product
Moderna mRNA1273.222Product
Pfizer COVID-19 Vaccine