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

NCT05367908 | Completed

• 1 other identifier: mRNA-1273-P914
• Study Type: observational
• Target: 1,501
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Evidation Health

San Mateo, California, 94402, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: April 11, 2022
• Primary Completion: August 14, 2022
• Study Completion: August 14, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

US (1)