COVID-19NCT05765578
An Observational Study of Moderna COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)
An observational study of COVID-19, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Moderna COVID-19 Vaccine, Moderna mRNA1273.222 Booster and Pfizer COVID-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 1,713 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 17 Jun 2024
- 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: Participants who have received the COVID-19 vaccine(s) and booster.
Who may be able to join
- Lives in the continental United States (US).
- Speaks, reads, and understands English.
- Is willing and able to submit vaccination card photo(s) or vaccination records.
- Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
- Is fully vaccinated against COVID-19 per protocol specified criteria.
Who cannot join
- Has been diagnosed with significant cognitive impairment or dementia.
- Is pregnant or planning to become pregnant during the study period.
- Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
- Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
- Is currently participating in a COVID-19 vaccine clinical trial.
- Is currently receiving chemotherapy or has received chemotherapy in the past 6 months.
Show all 10Show fewer
- Is currently taking steroids, such as prednisone, for any condition.
- Has been diagnosed with and taking immunosuppressants for rheumatoid arthritis, lupus or multiple sclerosis.
- 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 2 - An Observational Study to Evaluate the Immunogenicity of mRNA COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)
The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).
- Conditions
- COVID-19
- Being tested
- Moderna COVID-19 Vaccine, Moderna mRNA1273.222 Booster, Pfizer COVID-19 Vaccine, Moderna 2023 Updated COVID-19 vaccine (XBB.1.5), Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
- Keywords
- Immunogenicity, Moderna, mRNA-1273, Omicron, Vaccines
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderna COVID-19 VaccineBiological
Sterile liquid for injection. Intervention not administered through this study.
Moderna mRNA1273.222 BoosterBiological
Sterile liquid for injection. Intervention not administered through this study.
Pfizer COVID-19 VaccineBiological
Sterile liquid for injection. Intervention not administered through this study.
Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)Biological
Sterile liquid for injection. Intervention not administered through this study.
Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)Biological
Sterile liquid for injection. Intervention not administered through this study.
| Study group | Role | What they receive |
|---|---|---|
| Moderna-Only Vaccine/Booster Series (MMMM Group) | Individuals who previously received Moderna COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Moderna mRNA1273.222). Receives: Biological: Moderna COVID-19 Vaccine; Biological: Moderna mRNA1273.222 Booster | |
| Pfizer-Only Vaccine/Booster Series (PPPP Group) | Individuals who previously received Pfizer COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Pfizer-BNT 162b2 bivalent booster). Receives: Biological: Pfizer COVID-19 Vaccine | |
| Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group | Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5). Receives: Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) | |
| Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group | Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5). Receives: Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group
Measured: Day 29
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group
Measured: Day 91
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group
Measured: Day 181
Geometric Mean Ratio (GMR) of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 29 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Measured: Day 29
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 91 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Measured: Day 91
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 181 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Measured: Day 181
Secondary outcomes (2)
GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group
Measured: Day 29, Day 91, and Day 181
GMR of GMT Against All Other Omicron Variants and Subvariants Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Measured: Day 29, Day 91, and Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start8 Mar 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 1,713 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
- NCT05765578
- Sponsor's protocol ID
- mRNA-1273-P922
- Status last verified
- Jul 2024
- First submitted
- 9 Mar 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DisCOVEries 2 - An Observational Study to Evaluate the Immunogenicity of mRNA COVID-19 Bivalent Vaccines (Original and Omicron BA.4/BA.5) and 2023 Updated mRNA COVID-19 Vaccines (XBB.1.5)
- ClinicalTrials.gov ID
- NCT05765578
- Acronym / sponsor ID
- mRNA-1273-P922
- Conditions
- COVID-19
- Keywords
- Immunogenicity, Moderna, mRNA-1273, Omicron, Vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,713 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 13 Mar 2023 (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.
The goal of this observational study is to analyze binding antibody levels in adults in the United States (US) after receiving coronavirus disease 2019 (COVID-19) bivalent boosters (original and omicron BA.4/5) and updated COVID-19 vaccines (XBB.1.5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moderna-Only Vaccine/Booster Series (MMMM Group) | – | Biological: Moderna COVID-19 Vaccine, Biological: Moderna mRNA1273.222 BoosterIndividuals who previously received Moderna COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Moderna mRNA1273.222). |
| Pfizer-Only Vaccine/Booster Series (PPPP Group) | – | Biological: Pfizer COVID-19 VaccineIndividuals who previously received Pfizer COVID-19 vaccines in both primary series and first booster and a bivalent booster against Omicron BA.4/5 as the second booster dose (Pfizer-BNT 162b2 bivalent booster). |
| Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group | – | Biological: Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)Individuals who received Moderna 2023 updated COVID-19 vaccine (XBB.1.5). |
| Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group | – | Biological: Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)Individuals who received Pfizer 2023 updated COVID-19 vaccine (XBB.1.5). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have received the COVID-19 vaccine(s) and booster.
Key inclusion criteria (5 listed)
- Lives in the continental United States (US).
- Speaks, reads, and understands English.
- Is willing and able to submit vaccination card photo(s) or vaccination records.
- Is willing and able to self-collect capillary blood during the study period via an at-home whole-blood collection device.
- Is fully vaccinated against COVID-19 per protocol specified criteria.
Key exclusion criteria (10 listed)
- Has been diagnosed with significant cognitive impairment or dementia.
- Is pregnant or planning to become pregnant during the study period.
- Primary mailing address is a Post Office box, Army Post Office, Fleet Post Office, or Diplomatic Post Office address.
- Currently lives in a US military base located overseas, or US territories (Puerto Rico, US Virgin Islands, Guam, Northern Mariana Island, or American Samoa).
- Is currently participating in a COVID-19 vaccine clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderna COVID-19 VaccineSterile liquid for injection. Intervention not administered through this study. | Biological | Moderna-Only Vaccine/Booster Series (MMMM Group) |
| Moderna mRNA1273.222 BoosterSterile liquid for injection. Intervention not administered through this study. | Biological | Moderna-Only Vaccine/Booster Series (MMMM Group) |
| Pfizer COVID-19 VaccineSterile liquid for injection. Intervention not administered through this study. | Biological | Pfizer-Only Vaccine/Booster Series (PPPP Group) |
| Moderna 2023 Updated COVID-19 vaccine (XBB.1.5)Sterile liquid for injection. Intervention not administered through this study. | Biological | Moderna mRNA COVID-19 updated vaccine (XBB.1.5): Comparison Group |
| Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)Sterile liquid for injection. Intervention not administered through this study. | Biological | Pfizer-BioNTech COVID-19 updated vaccine (XBB.1.5): Reference Group |
Primary outcome
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group
Time frame: Day 29
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 91 Between MMMM Group and PPPP Group
Time frame: Day 91
GMT of SARS-CoV-2 Binding Antibody Titers Against Omicron BA.4/5 at Day 181 Between MMMM Group and PPPP Group
Time frame: Day 181
Geometric Mean Ratio (GMR) of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 29 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Time frame: Day 29
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 91 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Time frame: Day 91
GMR of GMT of Serum SARS-CoV-2 Binding Antibody Concentrations Against Omicron XBB.1 at Day 181 Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Time frame: Day 181
2 secondary outcomes
GMT Against All Other Omicron Variants and Subvariants Between MMMM Group and PPPP Group
Time frame: Day 29, Day 91, and Day 181
GMR of GMT Against All Other Omicron Variants and Subvariants Between Moderna 2023 Updated COVID-19 vaccine (XBB.1.5) and Pfizer 2023 Updated COVID-19 vaccine (XBB.1.5)
Time frame: Day 29, Day 91, and Day 181
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 31 Jul 2024.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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 COVID-19, 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 10 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 31 Jul 2024. 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?
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Binding Antibody Titers Against Omicron BA.4/5 at Day 29 Between MMMM Group and PPPP Group (time frame: Day 29). The study lists 6 primary outcomes in all. 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 31 Jul 2024.