Status:
COMPLETED
Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsors:
Parsemus Foundation
Conditions:
Sepsis Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Detailed Description
Clinical Design. Eligible healthcare workers (HCW) or first responders in the greater New Orleans area (n=60) meeting eligibility criteria will be enrolled into a 12 month study by the Louisiana State...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04475081
Start Date
September 22 2020
End Date
May 15 2022
Last Update
November 26 2024
Active Locations (1)
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1
Clinical and Translational Research Center
New Orleans, Louisiana, United States, 70112