Status:
ACTIVE_NOT_RECRUITING
A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Brief 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 ...
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. A...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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.
- EXCLUSION CRITERIA:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
April 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04852289
Start Date
April 20 2021
End Date
June 30 2027
Last Update
December 19 2025
Active Locations (2)
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1
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
2
NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus
Baltimore, Maryland, United States, 21244