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)

July 30, 2024 updated by: ModernaTX, Inc.

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1713

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Culver City, California, United States, 90230
        • Science37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants who have received the COVID-19 vaccine(s) and booster.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Day 29
Day 29
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
Day 91
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
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)
Time Frame: Day 29
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)
Time Frame: Day 91
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)
Time Frame: Day 181
Day 181

Secondary Outcome Measures

Outcome Measure
Time Frame
GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group
Time Frame: Day 29, Day 91, and Day 181
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)
Time Frame: Day 29, Day 91, and Day 181
Day 29, Day 91, and Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2023

Primary Completion (Actual)

June 17, 2024

Study Completion (Actual)

June 17, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1273-P922

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Moderna COVID-19 Vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe