COVID-19 (Coronavirus Disease 2019)NCT05682625
Understanding COVID-19 Vaccine Immunity in Tissue and Blood
An observational study of COVID-19 (Coronavirus Disease 2019), run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 (Coronavirus Disease 2019)
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Sep 2029
- 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
- Adult, Older adult
Study population: Adults (18 years and older) receiving a COVID-19 vaccine
Who may be able to join
- Adults 18yrs old and higher who are receiving a COVID-19 vaccine
Who cannot join
- Pregnancy
- Patients with contraindications for lymph node biopsy
- Active cancer
- Current use of immunosuppression drugs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study.
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Being tested
- No intervention
- Keywords
- Immunity, Vaccine
- 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.
Testing immune response to the COVID-19 vaccine over time
Measured: 1 day
Testing immune response to the COVID-19 vaccine over time
Measured: 7 days
Testing immune response to the COVID-19 vaccine over time
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startOct 2024 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Why it stopped: Difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 (Coronavirus Disease 2019)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Sharon Chinthrajah, Stanford University
- Investigators
- R. Sharon Chinthrajah, MD, Principal investigator, Stanford University, Sean N. Parker Center for Allergy and Asthma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682625
- Sponsor's protocol ID
- IRB-67705
- Other IDs
- 1U19AI167903-01
- Status last verified
- Sep 2024
- First submitted
- 9 Jan 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding COVID-19 Vaccine Immunity in Tissue and Blood
- ClinicalTrials.gov ID
- NCT05682625
- Acronym / sponsor ID
- IRB-67705
- Conditions
- COVID-19 (Coronavirus Disease 2019)
- Keywords
- Immunity, Vaccine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty with enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Jan 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 purpose of this study is to understand the effects of COVID-19 vaccines on the immune system and how the COVID-19 vaccines provide protection and induce long term memory. Adults who are receiving a COVID-19 vaccine will be invited to participate in this study.
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
- Age groups
- Adult, Older adult
- Study population
- Adults (18 years and older) receiving a COVID-19 vaccine
Key inclusion criteria (1 listed)
- Adults 18yrs old and higher who are receiving a COVID-19 vaccine
Key exclusion criteria (4 listed)
- Pregnancy
- Patients with contraindications for lymph node biopsy
- Active cancer
- Current use of immunosuppression drugs
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
Testing immune response to the COVID-19 vaccine over time
Time frame: 1 day
Testing immune response to the COVID-19 vaccine over time
Time frame: 7 days
Testing immune response to the COVID-19 vaccine over time
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
R. Sharon Chinthrajah, MD principal investigator
Stanford University, Sean N. Parker Center for Allergy and Asthma Research
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 (Coronavirus Disease 2019), 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 4 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: withdrawn, as of the sponsor's last update on 19 Sep 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 was withdrawn before enrolling participants, so there are no results.
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?
Testing immune response to the COVID-19 vaccine over time (time frame: 1 day). The study lists 3 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 19 Sep 2024.