Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis (NCT04475081) | Clinical Trial Compass
CompletedPhase 3
Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis
United States50 participantsStarted 2020-09-22
Plain-language 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.
Who can participate
Age range18 Years ā 70 Years
SexALL
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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 ā¦
What they're measuring
1
Induction of MDSCs
Timeframe: 30 days post vaccination
2
Induction of MDSCs
Timeframe: 60 days post vaccination
3
Induction of MDSCs
Timeframe: 12 months post vaccination
Trial details
NCT IDNCT04475081
SponsorLouisiana State University Health Sciences Center in New Orleans