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NCT05367908 Clinical Trial

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

SARS-CoV-2 Clinical Trial

— disCOVEries  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05367908
Other study ID # mRNA-1273-P914
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 11, 2022
Est. completion date August 14, 2022

Study information
Verified date October 2022
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1501
Est. completion date August 14, 2022
Est. primary completion date August 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Evidation Health San Mateo California

Sponsors (1)
Lead Sponsor Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Antibody Levels Since Receiving a COVID-19 Booster Vaccine at 0, 1, and 2 Months Post Enrollment Baseline (Month 0), Month 1, and Month 2
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