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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
| |
| Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group | Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5). |
| |
| Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group | Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderna COVID-19 Vaccine | Biological | Sterile liquid for injection. Intervention not administered through this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group | Day 29, Day 91, and Day 181 | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who have received the COVID-19 vaccine(s) and booster.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science37 | Culver City | California | 90230 | United States |
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Serum from blood samples will be used for binding antibody testing.
| Moderna mRNA1273.222 Booster | Biological | Sterile liquid for injection. Intervention not administered through this study. |
|
| Pfizer COVID-19 Vaccine | Biological | Sterile liquid for injection. Intervention not administered through this study. |
|
| Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) | Biological | Sterile liquid for injection. Intervention not administered through this study. |
|
| Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) | Biological | Sterile liquid for injection. Intervention not administered through this study. |
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| Day 29, Day 91, and Day 181 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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