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)

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Moderna COVID-19 Vaccine
* Biological: Moderna mRNA1273.222 Booster
* Biological: Pfizer COVID-19 Vaccine
* Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
* Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderna-Only Vaccine/Booster Series (MMMM Group)<br>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). | Biological: Moderna COVID-19 Vaccine<br>* Sterile liquid for injection. Intervention not administered through this study.<br>Biological: Moderna mRNA1273.222 Booster<br>* Sterile liquid for injection. Intervention not administered through this study.<br>|
| Pfizer-Only Vaccine/Booster Series (PPPP Group)<br>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). | Biological: Pfizer COVID-19 Vaccine<br>* Sterile liquid for injection. Intervention not administered through this study.<br>|
| Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group<br>Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5). | Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)<br>* Sterile liquid for injection. Intervention not administered through this study.<br>|
| Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group<br>Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5). | Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)<br>* Sterile liquid for injection. Intervention not administered through this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | Day 29, Day 91, and Day 181 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunogenicity, Moderna, mRNA-1273, Omicron, Vaccines