COVID-19 Clinical Trial
Official title:
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)
| Verified date | December 2023 |
| Source | ModernaTX, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Active, not recruiting |
| Enrollment | 1704 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Science37 | Culver City | California |
| Lead Sponsor | Collaborator |
|---|---|
| ModernaTX, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group | Day 91 | ||
| Primary | GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group | Day 181 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Secondary | GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group | Day 29, Day 91, and Day 181 | ||
| Secondary | 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 |
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