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SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine

NCT04952402 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-05-24

Study results available
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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).

Conditions

  • Covid19
  • SARS-CoV2 Infection

Interventions

BIOLOGICAL

Study-provided Moderna mRNA-1273 COVID-19 vaccine

Participants received a two-dose series (100 µg (0.5 mL) was administered intramuscularly (IM) at Day 0 and Day 28).

BIOLOGICAL

Community-provided Moderna mRNA-1273 COVID-19 Vaccine

Participants received a two-dose series.

BIOLOGICAL

Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine

Participants received a two-dose series.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • David Smith, MD, MAS · UCSD Antiviral Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2022-02-28
Completion
2023-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952402 on ClinicalTrials.gov