SARS-CoV-2disCOVEriesNCT05367908
A Study to Determine Antibody Levels After Receiving COVID-19 Boosters of Any Kind
An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 1,501 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 14 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discoveries - Different Immunization Boosters for Covid-19: Effect on Response in Antibodies
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Antibody Levels Since Receiving a COVID-19 Booster Vaccine at 0, 1, and 2 Months Post Enrollment
Measured: Baseline (Month 0), Month 1, and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start11 Apr 2022
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,501 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367908
- Sponsor's protocol ID
- mRNA-1273-P914
- Acronym
- disCOVEries
- Status last verified
- Oct 2022
- First submitted
- 6 May 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discoveries - Different Immunization Boosters for Covid-19: Effect on Response in Antibodies
- ClinicalTrials.gov ID
- NCT05367908
- Acronym / sponsor ID
- disCOVEries / mRNA-1273-P914
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,501 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.