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

Sponsor
National Institute on Aging (NIA) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04852289
Collaborator
(none)
160
Enrollment
2
Locations
28.2
Anticipated Duration (Months)
80
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans
    Anticipated Study Start Date :
    Nov 24, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2024

    Arms and Interventions

    ArmIntervention/Treatment
    >=65 Female

    Older Females

    >=65 Male

    Older Males

    18-64 Female

    Young Females

    18-64 Male

    Young Males

    Outcome Measures

    Primary Outcome Measures

    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. [4 months and one year data]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    In order to be eligible to participate in this study, an individual must meet all of the following criteria:

    1. Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.

    2. Male or female, aged 18 years or older.

    3. 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.

    4. Laboratory-confirmed negative tests for SARS-CoV-2 infection as determined by both of the following: Nasal turbinate swab (PCR) and Qualitative IgG Serology antibody testing.

    EXCLUSION CRITERIA

    An individual who meets any of the following criteria will be excluded from participation in this study:

    1. Unable to provide informed consent.

    2. Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.

    3. Pregnancy

    4. Received immunization therapy for COVID-19 prior to visit 1.

    In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include:

    1. Symptoms of a viral infection on visit 1 (defer until resolved).

    2. 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.

    3. 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.

    4. Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.

    5. 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.

    6. Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institute of Aging, Clinical Research UnitBaltimoreMarylandUnited States21224
    2NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campusBaltimoreMarylandUnited States21244

    Sponsors and Collaborators

    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Nan-Ping Weng, M.D., National Institute on Aging (NIA)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute on Aging (NIA)
    ClinicalTrials.gov Identifier:
    NCT04852289
    Other Study ID Numbers:
    • 10000383
    • 000383-AG
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Aug 10, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute on Aging (NIA)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021