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Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis

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ClinicalTrials.gov Identifier: NCT04475081
Recruitment Status : Not yet recruiting
First Posted : July 17, 2020
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
Parsemus Foundation
Information provided by (Responsible Party):
Paul Fidel, Louisiana State University Health Sciences Center in New Orleans

Brief Summary:
The objective of this randomized clinical trial is to test whether administration of live attenuated MMR vaccine (measles mumps rubella; Merck) to eligible adults at highest risk for contracting COVID-19 (healthcare workers, first responders), can induce non-specific trained innate immune leukocytes that can prevent/dampen pathological inflammation and sepsis associated with COVID-19-infection, if exposed.

Condition or disease Intervention/treatment Phase
Sepsis Syndrome Biological: MMR vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MMR vaccine vs placebo
Masking: Single (Participant)
Masking Description: Randomized by study nurse
Primary Purpose: Prevention
Official Title: Use of a Live Attenuated Vaccine Repurposed as an Innate Immune-based Preventive Against COVID-19-associated Sepsis/Inflammation
Estimated Study Start Date : August 17, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: MMR vaccination
Subjects will be randomized to receive the MMR Vaccine subcutaneously
Biological: MMR vaccine
Merck MMR-II vaccine

Placebo Comparator: Placebo control
Subjects will be randomized to receive sterile saline given subcutaneously
Biological: MMR vaccine
Merck MMR-II vaccine




Primary Outcome Measures :
  1. Induction of myeloid-derived suppressor cells (MDSCs) [ Time Frame: 14 days post-vaccination ]
    peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

  2. Induction of MDSCs [ Time Frame: 30 days post vaccination ]
    peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

  3. Induction of MDSCs [ Time Frame: 60 days post vaccination ]
    peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline

  4. Induction of MDSCs [ Time Frame: 12 months post vaccination ]
    peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold increase over baseline


Secondary Outcome Measures :
  1. COVID-19 infection positive [ Time Frame: 14 days post-vaccination ]
    COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

  2. COVID-19 infection positive [ Time Frame: 30 days post-vaccination ]
    COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

  3. COVID-19 infection positive [ Time Frame: 60 days post-vaccination ]
    COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

  4. COVID-19 infection positive [ Time Frame: 12 months post-vaccination ]
    COVID-19 antibodies (seropositive) or COVID-19 RNA+ as evidence of infection

  5. Health questionnaire [ Time Frame: 14 days post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  6. Health questionnaire [ Time Frame: 30 days post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  7. Health questionnaire [ Time Frame: 60 days post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  8. Health questionnaire [ Time Frame: 3 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  9. Health questionnaire [ Time Frame: 4 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  10. Health questionnaire [ Time Frame: 5 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  11. Health questionnaire [ Time Frame: 6 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  12. Health questionnaire [ Time Frame: 7 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  13. Health questionnaire [ Time Frame: 8 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  14. Health questionnaire [ Time Frame: 9 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  15. Health questionnaire [ Time Frame: 10 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  16. Health questionnaire [ Time Frame: 11 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)

  17. Health questionnaire [ Time Frame: 12 months post-vaccination ]
    Sepsis/lung inflammation, ICU/ventilator usage, in-patient health related co-morbidities and self-reporting mental status (such as general fatigue/stress level)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 years of age
  • Employed as a HCW (hospital, outpatient clinic, private office or 1st responder (EMS) in the greater New Orleans region
  • Able to provide a signed and dated informed consent
  • Able to provide pre-randomized blood specimen

Exclusion Criteria:

  • Any known MMR vaccine contraindication
  • Fever
  • Weakened resistance toward infections due to a disease in/of the immune system
  • Individuals receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year (see excluded medications).
  • Individuals with a congenital cellular immunodeficiency
  • Individuals with a malignancy involving bone marrow or lymphoid systems
  • Individuals with any serious underlying illness (such as malignancy). People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised (at the discretion of the ID Co-investigator)
  • Individuals with known or suspected HIV infection, even if asymptomatic or has normal immune function. (Due to the risk of disseminated MMR infection)
  • Individuals with an active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. A different site can be chosen if necessary
  • Pregnant or women who think they may test positive for pregnancy in this next month following MMR vaccine administration.
  • Individuals who have received a MMR or another live vaccine (i.e., Zostavax, nasal flu vaccine) within the last year
  • Individuals with known anaphylactic reaction to any of the ingredients present in the MMR vaccine
  • Individuals previously testing positive for SARS-CoV-2 or documented seropositive for SARS-CoV-2 antibodies prior to enrollment in this study

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): NCT04475081


Contacts
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Contact: Paul L Fidel, PhD 985-869-3445 pfidel@lsuhsc.edu
Contact: Mary Meyaski, RN 504-421-3241 mmeyas@lsuhsc.edu

Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
Parsemus Foundation
Investigators
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Principal Investigator: Paul L Fidel, PhD Louisiana State University Health Sciences Center - New Orleans
Publications:
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Responsible Party: Paul Fidel, Professor and Associate Dean, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT04475081    
Other Study ID Numbers: PF-1214
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to share de-identified participant data to other researchers at their request and with justification. Primary and secondary outcome measures will be shared
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years
Access Criteria: If fully justified for additional research purposes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paul Fidel, Louisiana State University Health Sciences Center in New Orleans:
MMR vaccine
COVID-19
Sepsis
trained innate immunity
myeloid-derived suppressor cells
inflammation
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock