ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-20
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04852289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion 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. * Able to speak and read English.
  4. * 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.
  5. * No knowledge of having had SARS-CoV-2, the virus that causes COVID-19.
  1. * 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.
  2. * Unable to provide informed consent.
  3. * Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
  4. * Pregnancy.
  5. * Symptoms of a viral infection on visit 1 (defer until resolved).
  6. * 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.
  7. * 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.
  8. * Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
  9. * 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.
  10. * Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.

Contacts and Locations

Principal Investigator

Nan-Ping P Weng, M.D.
PRINCIPAL_INVESTIGATOR
National Institute on Aging (NIA)

Study Locations (Sites)

National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, 21224
United States
NIH/NIA/Biomedical Research Center at Johns Hopkins Bayview campus
Baltimore, Maryland, 21244
United States

Collaborators and Investigators

Sponsor: National Institute on Aging (NIA)

  • Nan-Ping P Weng, M.D., PRINCIPAL_INVESTIGATOR, National Institute on Aging (NIA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-20
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-04-20
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Longevity
  • Cellular Immune
  • Antibodies
  • Natural History

Additional Relevant MeSH Terms

  • COVID-19