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

NCT ID: NCT05367908

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2022-08-14

Brief Summary

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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.

Detailed Description

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Conditions

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SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1: MMM (Moderna Vaccine Series)

Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster).

No interventions assigned to this group

Cohort 2: PPP (Pfizer Vaccine Series)

Participants who have only received Pfizer COVID-19 vaccines (that is, the 2-shot series and a booster).

No interventions assigned to this group

Cohort 3: V (Other Combination of Vaccines)

Participants who have received any other combinations of boosters authorized in the United States, such as the 2-shot Pfizer series and a Moderna booster (PPM), the 2-shot Moderna series and a Pfizer booster (MMP), or the 1-shot Johnson and Johnson vaccine with either a Moderna or Pfizer booster.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evidation Health

San Mateo, California, United States

Site Status

Countries

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United States

Other Identifiers

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mRNA-1273-P914

Identifier Type: -

Identifier Source: org_study_id

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