A Study to Determine Antibody Levels After Receiving COVI... | NCT05367908

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

NCT05367908

Sponsor

ModernaTX, Inc.

Status

Completed

Last Update Posted

Oct 13, 2022Actual

Enrollment

1,501Actual

Phase

Not provided

Conditions

SARS-CoV-2

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2022Actual

Primary Completion Date

Aug 14, 2022Actual

Completion Date

Aug 14, 2022Actual

First Submitted Date

May 6, 2022

First Submission Date that Met QC Criteria

May 6, 2022

First Posted Date

May 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2022

Last Update Posted Date

Oct 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,501Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1: MMM (Moderna Vaccine Series)		Participants who have only received Moderna COVID-19 vaccines (that is, the 2-shot series and a booster).
Cohort 2: PPP (Pfizer Vaccine Series)		Participants who have only received Pfizer COVID-19 vaccines (that is, the 2-shot series and a booster).
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.

Interventions

Not provided

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Recruitment for this study will be aimed primarily at members of the Moderna Community on the Evidation platform. Evidation is an online platform where participants can connect digitally for educational health content, health data sharing, and research purposes. The study team will use an online strategy to invite, recruit, verify eligibility, consent, and enroll participants into this study. Potential participants will be provided a link to the study landing page on the Evidation platform, where they will be presented with an overview of the study. From the landing page, potential participants will be asked to complete a screening survey to determine participant eligibility and assess COVID-19 vaccination history to assist in cohort assignment.

Sampling Method

Non-Probability Sample