Observing immune responses to COVID-19 vaccines in different age groups
A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
This study is testing how well COVID-19 vaccines work in young and older adults by looking at their immune responses over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT04852289 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the immune responses of young and older healthy adults after receiving COVID-19 vaccines from Pfizer or Moderna. Participants, aged 18 and older, will be screened and monitored over a five-year period to assess the presence and longevity of SARS-CoV-2 specific CD8 T cells in their blood. The study will analyze how age and sex may influence these immune responses, providing insights into cellular immunity against COVID-19. Participants will not receive the vaccine through the study but must get vaccinated at an authorized location.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older who have not previously contracted COVID-19 and are planning to receive their first vaccine dose soon.
Not a fit: Patients who have already contracted COVID-19 or those who are unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how age affects immune responses to COVID-19 vaccines, potentially guiding vaccination strategies.
How similar studies have performed: Other studies have shown promising results in understanding immune responses to vaccines, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Baltimore, Maryland and 1 other locations
- National Institute of Aging, Clinical Research Unit — Baltimore, Maryland, United States (Recruiting)
- NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Nan-Ping Weng, M.D. — National Institute on Aging (NIA)
- Study coordinator: Julia L McKelvey, R.N.
- Email: mckelveyju@nih.gov
- Phone: (410) 350-3929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.