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OpenTrials
Completed

NCT Number: NCT05367908

A Study to Determine Antibody Levels After Receiving COVID-19 Boosters of Any Kind

This study will investigate antibody levels with respect to time since receiving a COVID-19 booster shot. The study will be decentralized, where participants can complete all study tasks at home. Self-reported participant information will be collected via surveys conducted at intake and monthly throughout the study. Participants will also perform monthly at-home capillary blood draws via YourBio devices that will be mailed to the designated laboratory for sample processing and antibody testing.

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Key information

Conditions

SARS-CoV-2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evidation Health

San Mateo, California, 94402, 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.
  • Has been vaccinated against COVID-19 with a U.S.-authorized vaccine (that is, received the single shot J&J vaccine or both shots in the Pfizer or Moderna series).
  • Has received a COVID-19 booster between September 2021 and screening.
  • Is willing and able to submit vaccination card photo(s).
  • Is willing and able to self-collect capillary blood 3 times during the study period via an at-home whole-blood collection device (that is, the YourBio TAP II Device).

Exclusion criteria

  • Has been diagnosed with significant cognitive impairment or dementia.
  • Has received more than one COVID-19 vaccine booster at screening.
  • 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 or is taking medications for rheumatoid arthritis (RA), lupus or multiple sclerosis (MS).
  • 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

Primary outcomes

  1. Change in Antibody Levels Since Receiving a COVID-19 Booster Vaccine at 0, 1, and 2 Months Post Enrollment

    Time frame: Baseline (Month 0), Month 1, and Month 2

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

Discoveries - Different Immunization Boosters for Covid-19: Effect on Response in Antibodies

Acronym: disCOVEries

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Oct 13, 2022

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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