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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)

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ClinicalTrials.gov Identifier: NCT05765578
Recruitment Status : Active, not recruiting
First Posted : March 13, 2023
Last Update Posted : December 22, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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).

Condition or disease Intervention/treatment
COVID-19 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)

Study Design
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Study Type : Observational
Actual Enrollment : 1704 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : March 8, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Biological: Moderna COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.

Biological: Moderna mRNA1273.222 Booster
Sterile liquid for injection. Intervention not administered through this study.
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).
 Biological: Pfizer COVID-19 Vaccine
Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group
Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5).
 Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.
Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group
Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5).
 Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Sterile liquid for injection. Intervention not administered through this study.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Day 29 ]
  2. GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group [ Time Frame: Day 91 ]
  3. GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group [ Time Frame: Day 181 ]
  4. 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) [ Time Frame: Day 29 ]
  5. 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) [ Time Frame: Day 91 ]
  6. 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) [ Time Frame: Day 181 ]

Secondary Outcome Measures :
  1. GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group [ Time Frame: Day 29, Day 91, and Day 181 ]
  2. 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) [ Time Frame: Day 29, Day 91, and Day 181 ]

Biospecimen Retention:   None Retained
Serum from blood samples will be used for binding antibody testing.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who have received the COVID-19 vaccine(s) and booster.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05765578


Locations
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United States, California
Science37
Culver City, California, United States, 90230
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05765578    
Other Study ID Numbers: mRNA-1273-P922
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: December 22, 2023
Last Verified: December 2023
Keywords provided by ModernaTX, Inc.:
Immunogenicity
Moderna
mRNA-1273
Omicron
Vaccines
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs