Background:The immune response is how the body recognizes and defends itself against foreign andharmful substances. Researchers want to compare the immune responses between young andolder healthy adults after they receive vaccine doses for COVID-19. This research mayhelp 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 thefirst dose of a COVID-19 vaccine within the next month or have received at least thefirst 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 avaccine location.Participants who have not yet been vaccinated will have 7 visits. The first 4 visits willoccur in the first month before and after each vaccination. The last 3 visits will occur6 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 thelast 6 months will have 3 visits. The first visit will occur within 6 months of receivingthe first vaccine dose. The last 2 visits will occur 1 year and 2 years after the firstvaccine dose.At visits, participant will review their medical history. Their height, weight, and/orvital signs will be measured. They will give blood samples after fasting. They may giveurine samples. They may have a nasal swab test for COVID-19.
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:
1. Correlations between CD8 T cell responses in vitro and circulating SARS-CoV-2
specific antibodies
2. Plasma inflammatory cytokines and other biomarkers
- 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.
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States
NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus
Baltimore, Maryland, United States
Julia L McKelvey, R.N.
(410) 350-3929
mckelveyju@nih.gov
Nan-Ping Weng, M.D.
(410) 558-8341
wengn@grc.nia.nih.gov
Nan-Ping Weng, M.D., Principal Investigator
National Institute on Aging (NIA)