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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 293 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv293
  2. Primary completion date: Dec 4, 2025 to Dec 31, 2026v292
  3. Re-verified, no change to tracked fieldsv291
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 160 to confirmed 78 · Site details revised at 2 of 2 sitesv290 Show 2 more changesShow less
    • Enrollment target: estimated 160 to confirmed 78
    • Site details revised at 2 of 2 sites
  5. 2 versions Re-verified since Dec 31, 2024, no change to tracked fieldsv288-v289
Show 44 earlier versionsHide 44 earlier versions
  1. Primary completion date: Dec 4, 2024 to Dec 4, 2025v287
  2. 4 versions Re-verified since Apr 23, 2024, no change to tracked fieldsv283-v286
  3. Completion date: Dec 4, 2024 to Jun 30, 2027v282
  4. Eligibility criteria expanded, about 17 words Study description expanded, about 3 wordsv281 Show 1 more changeShow less
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv280
  6. Primary completion date: Mar 31, 2023 to Dec 4, 2024 Completion date: Mar 31, 2024 to Dec 4, 2024v279 Show 1 more changeShow less
    • Completion date: Mar 31, 2024 to Dec 4, 2024
  7. Re-verified, no change to tracked fieldsv278
  8. Site contacts updated at 1 of 2 sitesv277
  9. 11 versions Re-verified since Jun 21, 2022, no change to tracked fieldsv266-v276
  10. Study description expanded, about 151 words Eligibility criteria expanded, about 1 wordv265 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  11. 21 versions Re-verified since May 17, 2022, no change to tracked fieldsv244-v264
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04852289
Lead Sponsor National Institute on Aging (NIA)
Conditions COVID-19
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov