A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
- Conditions
- COVID-19
- Registration Number
- NCT04852289
- Lead Sponsor
- National Institute on Aging (NIA)
- 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 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:
1. Correlations between CD8 T cell responses in vitro and circulating SARS-CoV-2 specific antibodies
2. Plasma inflammatory cytokines and other biomarkers
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 4 months and one year data To determine quantitative changes of S protein specific CD8 T cells prior and post COVID-19 vaccination.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
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