Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by David Smith, MD, MAS (ucsd)
Photo of David Smith
David Smith

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of mRNA COVID-19 vaccines in: • People with prior COVID-19 (SARS-CoV-2 infection) who were in the ACTIV-2/A5401 study. And • People who have never had COVID-19 (SARS-CoV-2 infection).

Details

This study is for people who had COVID-19 and participated in ACTIV-2/A5401 and received either experimental treatment, a standard of care COVID-19 treatment, or placebo. This study is also for people who have not previously had a COVID-19 infection. The study is designed to evaluate how the immune system responds to mRNA-COVID-19 vaccines in these participants. The safety of mRNA COVID-19 vaccines in persons with prior COVID-19 who did and did not receive prior experimental treatment for COVID-19 will be explored. Prior infection with or without treatment could increase, decrease, or have no significant effect on the response to mRNA COVID-19 vaccines, as well as the risk of side effects from these vaccines. Immune responses of participants who have not previously been infected with COVID-19 will be compared to those who have previously had COVID-19.

Keywords

Covid19 SARS-CoV2 Infection Vaccines Moderna mRNA-1273 COVID-19 vaccine Community-provided mRNA-based COVID-19 vaccine Community-Provided Moderna mRNA-1273 COVID-19 Vaccine mRNA-based COVID-19 vaccine

Eligibility

You can join if…

Open to people ages 18 years and up

  • For all participants: Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.
  • For all participants: Individuals ≥18 years of age
  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Receipt of all selected investigational therapy or active comparator/placebo for that therapy at selected sites.
  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial and will be receiving study-provided Moderna mRNA-1273 COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥60 days and ≤240 days prior to study entry.
  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial and will be receiving community-provided mRNA-based COVID-19 vaccine: Receipt of the last dose of investigational therapy or active comparator/placebo for that therapy ≥60 and ≤240 days prior to planned receipt of the first dose of community-provided vaccine.

You CAN'T join if...

  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of prior receipt of a non-mRNA-based COVID-19 vaccine
  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of receipt of the second dose of an mRNA-based COVID-19 vaccine.
  • For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Self-report of a second SARS-CoV-2 infection after the infection that qualified the participant for ACTIV-2/A5401.
  • For non-A5401/ACTIV-2 participants: Self-report of receipt of any prior COVID-19 vaccine.
  • For non-A5401/ACTIV-2 participants: Known prior history of any SARS-CoV-2-positive test (e.g., PCR test, Nucleic Acid Amplification Test (NAAT), antigen test, serology test).
  • For participants who will receive study-provided Moderna mRNA-1273 COVID-19 vaccine: Known allergy to any component of the Moderna COVID-19 vaccine.

Locations

  • UCLA CARE Center CRS accepting new patients
    Los Angeles California 90035-4709 United States
  • Harbor-UCLA CRS not yet accepting patients
    Torrance California 90502 United States

Lead Scientist at University of California Health

  • David Smith, MD, MAS (ucsd)
    Davey Smith, MD, MAS, is an infectious disease specialist and translational research virologist. In his translational research, he uses basic science techniques to answer clinically relevant questions. Dr. Smith's primary research involves both figuring out how to stop the transmission of HIV and curing HIV, and he has published over 200 scientific publications in these areas.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT04952402
Phase
Phase 4
Study Type
Interventional
Last Updated