A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans

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

• 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.