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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04952402
Recruitment Status : Active, not recruiting
First Posted : July 7, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV2 Infection Biological: Moderna mRNA-1273 COVID-19 vaccine Biological: Community-provided mRNA-based COVID-19 vaccine Biological: Community-Provided Moderna mRNA-1273 COVID-19 Vaccine Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine
Actual Study Start Date : July 16, 2021
Actual Primary Completion Date : January 28, 2022
Estimated Study Completion Date : December 16, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-based COVID-19 vaccine
To be administered intramuscularly (IM) at Day 0 and Day 28.
 Biological: Moderna mRNA-1273 COVID-19 vaccine
100 µg (0.5 mL) to be administered intramuscularly (IM) at Day 0 and Day 28.

Biological: Community-provided mRNA-based COVID-19 vaccine
Two dose series.

Biological: Community-Provided Moderna mRNA-1273 COVID-19 Vaccine
Participants will receive (or have recently received) a community-provided Moderna mRNA-1273 COVID-19 vaccine at (or before) Day 0 and study-provided Moderna mRNA-1273 COVID-19 vaccine, 100 µg (0.5 mL) to be administered intramuscularly (IM) at at least 28 days apart.


Outcome Measures
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Primary Outcome Measures :
  1. Neutralizing antibody (NAb) level at least [ Time Frame: At least 56 days after the first dose of the study- or community-provided vaccine ]

Secondary Outcome Measures :
  1. Relative pre-vaccine to post-vaccine change in NAb response [ Time Frame: The pre-vaccine NAb measurement will be obtained before the first dose of the vaccine, and the post-vaccine measurement will be obtained at least 56 days after the first dose of the vaccine. ]
    Defined as the ratio of post-vaccine level/pre-vaccine level.

  2. New Grade 3 or higher AE, or SAE, or AE leading to change or discontinuation in vaccine receipt [ Time Frame: From first dose of the mRNA-based COVID-19 vaccine and through 56 days after the first dose of vaccine. ]
  3. Proportion of participants with Grade 1 or higher allergic reaction from first dose of the mRNA-based COVID-19 vaccine. [ Time Frame: Through the visit 56 days after the first dose of the vaccine ]
  4. Proportion of participants with Grade 2 or higher injection site reaction from first dose of the mRNA-based COVID-19 vaccine. [ Time Frame: Through the visit 56 days after the first dose of the vaccine ]
  5. CD4+ T cell response to SARS-CoV-2 spike protein [ Time Frame: At the visit 56 days after the first dose of the vaccine ]
  6. CD8+ T cell response to SARS-CoV-2 spike protein [ Time Frame: At the visit 56 days after the first dose of the vaccine ]
  7. IgG serologic response to SARS-CoV-2 spike protein at receptor binding domain (RBD) and N terminal domain (NTD) and Matrix (M) protein. [ Time Frame: At the visit 56 days after the first dose of the vaccine ]
  8. IgM serologic response to SARS-CoV-2 spike protein at receptor binding domain (RBD) and N terminal domain (NTD) and Matrix (M) protein. [ Time Frame: At the visit 56 days after the first dose of the vaccine ]
  9. Flow cytometry of PBMC for markers of exhaustion on B and T cells [ Time Frame: At study entry/Day 0 and 56 days after the first vaccine dose. ]
  10. Relative pre-vaccine to post-vaccine change in NAb response [ Time Frame: The pre-vaccine NAb measurement will be obtained before the first dose of the vaccine, and the post-vaccine measurement will be obtained at least 56 days after the first dose of the vaccine. ]
    Defined as the ratio of post-vaccine level/pre-vaccine level by received vaccine, i.e., Moderna versus Pfizer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952402


Locations
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United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90035-4709
Harbor-UCLA CRS
Torrance, California, United States, 90502
United States, Illinois
Rush University CRS (Site ID: 2702)
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, United States, 02115
United States, North Carolina
Chapel Hill CRS (Site ID: 3201)
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Clinical Research Site
Cleveland, Ohio, United States, 44106
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104-9929
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Study Chair: David Smith, MD, MAS UCSD Antiviral Research Center
More Information
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04952402    
Other Study ID Numbers: A5404
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
Access Criteria:
  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.
  • For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs