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Virus Therapy

Cohort: ACTIV-2/A5401 for COVID-19

Phase 4
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the visit 56 days after the first dose of the vaccine
Awards & highlights

Study Summary

This trial will test if the vaccine can help prevent COVID-19 in people who have never had it before and in people who have had it before.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study entry/day 0 and 56 days after the first vaccine dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study entry/day 0 and 56 days after the first vaccine dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neutralizing Antibody (NAb) Level
Secondary outcome measures
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine
Geometric Mean of Relative Change in Neutralizing Antibody Levels From Pre-vaccine to Post-vaccine by Received Vaccine
Number of Participants With Grade 1 or Higher Allergic Reaction
+2 more
Other outcome measures
CD4+ T Cell Response to SARS-CoV-2 Spike Protein
CD8+ T Cell Response to SARS-CoV-2 Spike Protein
Flow Cytometry of PBMC for Markers of Exhaustion on B and T Cells
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort: COVID-19 NaïveExperimental Treatment1 Intervention
Participants without known history of prior SARS-CoV-2 infection defined as no known history of any SARS-CoV-2 positive test (non-ACTIV-2/A5401 participants).
Group II: Cohort: ACTIV-2/A5401Experimental Treatment3 Interventions
Participants of the ACTIV-2/A5401 randomized trial who received a select investigational (active) therapy (AZD7442 IM or IV, BRII-196 + BRII 198 IV, SAB 185 (3,840 or 10,240 units/kg) IV, BMS 096414+BMS 986413 subcutaneous, Camostat Oral) or its corresponding comparator (Placebo).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study-provided Moderna mRNA-1273 COVID-19 vaccine
2021
Completed Phase 4
~50
Community-provided Moderna mRNA-1273 COVID-19 Vaccine
2021
Completed Phase 4
~50
Community-Provided Pfizer-BioNTech BNT162b2 COVID-19 Vaccine
2021
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,089 Total Patients Enrolled
78 Trials studying COVID-19
292,165 Patients Enrolled for COVID-19
David Smith, MD, MASStudy ChairUCSD Antiviral Research Center
2 Previous Clinical Trials
4,105 Total Patients Enrolled
1 Trials studying COVID-19
4,044 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are responsible for overseeing this clinical trial?

"Presently, this study is recruiting at MGH CRS in Boston, Harbor-UCLA CRS in Torrance, University of Washington AIDS CRS in Seattle as well as 11 other locations."

Answered by AI

When will the FDA give their okay to mRNA-1273?

"The Moderna mRNA-1273 COVID-19 vaccine is currently in Phase 4 trials, which means that the drug has been approved and is safe."

Answered by AI

Is Moderna's mRNA-1273 COVID-19 vaccine effective?

"The Moderna mRNA-1273 COVID-19 vaccine was first studied in 2020 by Sundance Clinical Research. 8 trials have completed and 27 more are ongoing, with a large portion being hosted in Boston, Massachusetts."

Answered by AI

What are the unique aspects of this clinical trial?

"To date, there have been 27 active studies for the Moderna mRNA-1273 COVID-19 vaccine in 219 cities and 22 countries. The first clinical trial was completed in 2020 by ModernaTX, Inc. Phase 3 of the study included 30,000 patients. In total, since 2020 8 different studies have been conducted."

Answered by AI

How many potential participants are being asked to join this clinical trial?

"As of April 20th, 2022, this study is not recruiting patients. However, there are presently 1153 trials actively searching for patients with covid-19 and 27 trials for Moderna mRNA-1273 COVID-19 vaccine that are admitting participants."

Answered by AI

Are we able to sign up for this experiment at the moment?

"Unfortunately, this study is not admitting patients at the moment. The listing was first created on July 16th 2021 but was edited as recently as April 20th 2022. However, there are presently 1153 clinical trials actively admitting participants with covid-19 and 27 trials for Moderna mRNA-1273 COVID-19 vaccine actively searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
New York
Maine
Ohio
How old are they?
18 - 65
What site did they apply to?
Case Clinical Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
2021. "SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04952402.
~11 spots leftby Apr 2025
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