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OpenTrials
Completed

NCT Number: NCT05765578

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)

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Science37

Culver City, California, 90230, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moderna COVID-19 Vaccine

Biological

Sterile liquid for injection. Intervention not administered through this study.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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