COVID-19NCT04664309
Understanding Immunity to the COVID-19 Vaccines
An observational study of COVID-19 and Immunity, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Type of treatment
- Vaccines
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 6 Jan 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: Adults (18 years and older) receiving a COVID-19 vaccine
Who may be able to join
- Adults who are receiving a COVID-19 vaccine
Who cannot join
- Patients with special risks attendant to venipuncture
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Hospital, and Clinics
Stanford, California, 94305
About this study
The purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.
- Being tested
- No intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adults who are receiving a COVID-19 vaccine Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with immunity to COVID-19 vaccines over time
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start26 Mar 2021
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
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 Stanford UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kari Christine Nadeau, MD, PhD, Stanford University
- Investigators
- Kari Nadeau, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664309
- Sponsor's protocol ID
- IRB-60171
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Immunity to the COVID-19 Vaccines
- ClinicalTrials.gov ID
- NCT04664309
- Acronym / sponsor ID
- IRB-60171
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 11 Dec 2020 (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 purpose of this study is to test over time immunity to the COVID-19 vaccines. Adults who are receiving COVID-19 vaccines will be invited to participate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: No interventionAdults who are receiving a COVID-19 vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years and older) receiving a COVID-19 vaccine
Key inclusion criteria (1 listed)
- Adults who are receiving a COVID-19 vaccine
Key exclusion criteria (1 listed)
- Patients with special risks attendant to venipuncture
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 |
|---|---|---|
| No interventionNo intervention | Other | Participants |
Primary outcome
Percentage of participants with immunity to COVID-19 vaccines over time
Time frame: 1 year
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 28 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Kari Nadeau, MD, PhD principal investigator
Stanford University
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 and Immunity, run by Stanford University 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 1 inclusion and 1 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 28 Feb 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?
Percentage of participants with immunity to COVID-19 vaccines over time (time frame: 1 year). 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 28 Feb 2022.