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

NCT04852289 | Active Not Recruiting

• 2 other identifiers: 10000383000383-AG
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Keywords

Longevity; Cellular Immune; Antibodies; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  To determine quantitative changes of S protein specific CD8 T cells prior and post COVID-19 vaccination.

  4 months and one year data

Study Arms (4)

>=65 Female

Older Females

>=65 Male

Older Males

18-64 Female

Young Females

18-64 Male

Young Males

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will consist of healthy men and women over 18 years of age who plan to have a COVID-19 vaccination within 30 days. An accrual ceiling of 160 participants will be recruited and screened until 140 eligible participants are enrolled, which are calculated based on four groups: young females (18-64), young males (18-64), old females (\>=65), old males (\>=65). Each group with 35 people to account for HLA-A2+, variations in HLA-A2 genotype percentage, and possible dropout. We will include both genders, 18 years of age and older, all races, and residents of the state of Maryland.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (2)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus

Baltimore, Maryland, 21244, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nan-Ping P Weng, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 21, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12-17

Locations

US (2)