COVID-19NCT04852289
A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
An observational study of COVID-19, run by National Institute on Aging (NIA) at 2 sites in United States.
Trial summary
Background: The immune response is how the body recognizes and defends itself against foreign and harmful substances. Researchers want to compare the immune responses between young and older healthy adults after they receive vaccine doses for COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2021to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will consist of healthy men and women over 18 years of age who plan to have a COVID-19 vaccination within 30 days. An accrual ceiling of 160 participants will be recruited and screened until 140 eligible participants are enrolled, which are calculated based on four groups: young females (18-64), young males (18-64), old females (>=65), old males (>=65). Each group with 35 people to account for HLA-A2+, variations in HLA-A2 genotype percentage, and possible dropout. We will include both genders, 18 years of age and older, all races, and residents of the state of Maryland.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or older.
- Able to speak and read English.
- Willingness and ability to come to the NIH/National Institute on Aging Clinical Research Unit at MedStar Harbor Hospital or the NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus in Baltimore for study procedures.
- No knowledge of having had SARS-CoV-2, the virus that causes COVID-19.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in
- this study:
- Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
- Unable to provide informed consent.
- Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
- Pregnancy.
Show all 13Show fewer
- In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include:
- Symptoms of a viral infection on visit 1 (defer until resolved).
- Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials, antivirals.
- Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal, inhaled, or for joint injection.
- Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
- We wish to only select healthy confirmed COVID-19 negative patients. Therefore, those who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or who has symptoms will be deferred for 14 days.
- Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus
Baltimore, Maryland, 21244
About this study
Background:
The immune response is how the body recognizes and defends itself against foreign and harmful substances. Researchers want to compare the immune responses between young and older healthy adults after they receive vaccine doses for COVID-19. This research may help to determine whether age impacts cell response to COVID-19 vaccines.
Read more
Objective:
To study the immune response of people who receive Pizer or Moderna COVID-19 vaccines.
Eligibility:
People aged 18 and older who have not had COVID-19 and who either plan to receive the first dose of a COVID-19 vaccine within the next month or have received at least the first of 2 doses of the vaccine within the last 6 months.
Design:
Participants will be screened by telephone.
Participants will not get the COVID-19 vaccine in this study. They must get it through a vaccine location.
Participants who have not yet been vaccinated will have 7 visits. The first 4 visits will occur in the first month before and after each vaccination. The last 3 visits will occur 6 months, 1 year, and 2 years after completed vaccination.
Participants who have received at least 1 of 2 doses of the COVID-19 vaccine within the last 6 months will have 3 visits. The first visit will occur within 6 months of receiving the first vaccine dose. The last 2 visits will occur 1 year and 2 years after the first vaccine dose.
At visits, participant will review their medical history. Their height, weight, and/or vital signs will be measured. They will give blood samples after fasting. They may give urine samples. They may have a nasal swab test for COVID-19.
Read the detailed description
Study Description:
This study is to identify SARS-CoV-2 S protein specific CD8 T cells in the blood of COVID-19 vaccinated participants. Pfizer and Moderna made vaccines will be used in this study. As both vaccines are mRNA-based encoding S protein of SARS-CoV-2 and require two doses, the CD8 T cell response is expected to be comparable. We will also measure general health factors using blood samples. By analyzing the frequency, differentiation, and expansion of these SARS-CoV-2 S protein specific CD8 T cells, we hope to shed light into the CD8 T cell response to COVID-19 vaccine and its change with age.
Objectives:
To determine the proportion of individuals who develop and maintain SARS-CoV-2 S protein specific CD8 T cells after vaccination as a proxy for cellular immunity to future SARS CoV-2 exposure, to determine if there are differences in CD8 T cell response to COVID-19 vaccines between young and older healthy adults, and the longevity of CD8 T cell response over a five year follow up.
Endpoints:
Primary Endpoint: Presence or absence of various SARS-CoV-2 S protein specific CD8 T cells in COVID-19 vaccine participants and their quantitative changes during and after the course of vaccination, and over a five year time.
Secondary Endpoint: Determining the effect of age (either prespecify age >65 vs <65 or explore as a continuous variable) and sex on presence of SARS-CoV-2 S protein specific CD8 T cells
Exploratory Endpoints:
- Correlations between CD8 T cell responses in vitro and circulating SARS-CoV-2 specific antibodies
- Plasma inflammatory cytokines and other biomarkers
- Conditions
- COVID-19
- Keywords
- Longevity, Cellular Immune, Antibodies, Natural History
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| >=65 Female | Older Females | |
| >=65 Male | Older Males | |
| 18-64 Female | Young Females | |
| 18-64 Male | Young Males |
What is being measured
The primary outcome is the main question the study is designed to answer.
We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy COVID-19 vaccinated participants to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis.
To determine quantitative changes of S protein specific CD8 T cells prior and post COVID-19 vaccination.
Measured: 4 months and one year data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
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.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nan-Ping P Weng, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852289
- Sponsor's protocol ID
- 10000383
- Other IDs
- 000383-AG
- Status last verified
- 7 Jul 2026
- First submitted
- 20 Apr 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will deposit the research data to NCBI without individual identity information when the findings are written for publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
- ClinicalTrials.gov ID
- NCT04852289
- Acronym / sponsor ID
- 10000383
- Conditions
- COVID-19
- Keywords
- Longevity, Cellular Immune, Antibodies, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Apr 2021 (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.
Background:
The immune response is how the body recognizes and defends itself against foreign and harmful substances. Researchers want to compare the immune responses between young and older healthy adults after they receive vaccine doses for COVID-19. This research may help to determine whether age impacts cell response to COVID-19 vaccines.
Objective:
To study the immune response of people who receive Pizer or Moderna COVID-19 vaccines.
Eligibility:
People aged 18 and older who have not had COVID-19 and who either plan to receive the first dose of a COVID-19 vaccine within the next month or have received at least the first of 2 doses of the vaccine within the last 6 months.
Design:
Participants will be screened by telephone.
Participants will not get the COVID-19 vaccine in this study. They must get it through a vaccine location.
Participants who have not yet been vaccinated will have 7 visits. The first 4 visits will occur in the first month before and after each vaccination. The last 3 visits will occur 6 months, 1 year, and 2 years after completed vaccination.
Participants who have received at least 1 of 2 doses of the COVID-19 vaccine within the last 6 months will have 3 visits. The first visit will occur within 6 months of receiving the first vaccine dose. The last 2 visits will occur 1 year and 2 years after the first vaccine dose.
At visits, participant will review their medical history. Their height, weight, and/or vital signs will be measured. They will give blood samples after fasting. They may give urine samples. They may have a nasal swab test for COVID-19.
Detailed description
Study Description:
This study is to identify SARS-CoV-2 S protein specific CD8 T cells in the blood of COVID-19 vaccinated participants. Pfizer and Moderna made vaccines will be used in this study. As both vaccines are mRNA-based encoding S protein of SARS-CoV-2 and require two doses, the CD8 T cell response is expected to be comparable. We will also measure general health factors using blood samples. By analyzing the frequency, differentiation, and expansion of these SARS-CoV-2 S protein specific CD8 T cells, we hope to shed light into the CD8 T cell response to COVID-19 vaccine and its change with age.
Objectives:
To determine the proportion of individuals who develop and maintain SARS-CoV-2 S protein specific CD8 T cells after vaccination as a proxy for cellular immunity to future SARS CoV-2 exposure, to determine if there are differences in CD8 T cell response to COVID-19 vaccines between young and older healthy adults, and the longevity of CD8 T cell response over a five year follow up.
Endpoints:
Primary Endpoint: Presence or absence of various SARS-CoV-2 S protein specific CD8 T cells in COVID-19 vaccine participants and their quantitative changes during and after the course of vaccination, and over a five year time.
Secondary Endpoint: Determining the effect of age (either prespecify age >65 vs <65 or explore as a continuous variable) and sex on presence of SARS-CoV-2 S protein specific CD8 T cells
Exploratory Endpoints:
- Correlations between CD8 T cell responses in vitro and circulating SARS-CoV-2 specific antibodies
- Plasma inflammatory cytokines and other biomarkers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| >=65 Female | – | –Older Females |
| >=65 Male | – | –Older Males |
| 18-64 Female | – | –Young Females |
| 18-64 Male | – | –Young Males |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will consist of healthy men and women over 18 years of age who plan to have a COVID-19 vaccination within 30 days. An accrual ceiling of 160 participants will be recruited and screened until 140 eligible participants are enrolled, which are calculated based on four groups: young females (18-64), young males (18-64), old females (>=65), old males (>=65). Each group with 35 people to account for HLA-A2+, variations in HLA-A2 genotype percentage, and possible dropout. We will include both genders, 18 years of age and older, all races, and residents of the state of Maryland.
Key inclusion criteria (6 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 18 years or older.
- Able to speak and read English.
- Willingness and ability to come to the NIH/National Institute on Aging Clinical Research Unit at MedStar Harbor Hospital or the NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus in Baltimore for study procedures.
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in
- Unable to verify identification of volunteer by state issued ID card, driver s license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
- Unable to provide informed consent.
- Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
- Pregnancy.
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
We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy COVID-19 vaccinated participants to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis.
Time frame: 4 months and one year data
To determine quantitative changes of S protein specific CD8 T cells prior and post COVID-19 vaccination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. We will deposit the research data to NCBI without individual identity information when the findings are written for publications.
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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.
Nan-Ping P Weng, M.D. principal investigator
National Institute on Aging (NIA)
2 sites 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 National Institute on Aging (NIA) at 2 sites 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 6 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy COVID-19 vaccinated participants to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis. (time frame: 4 months and one year data). 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 9 Jul 2026.