Phase 3
N=50
Use of a Live Attenuated Vaccine as an Immune-based Preventive Against COVID-19-associated Sepsis
Sepsis Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04475081 ↗Enrolled (actual)
50
Serious AEs
2.9%
Results posted
Nov 2024
Primary outcome: Primary: Induction of MDSCs — 0.19; 0.11 fold change compared to baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MMR vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction of MDSCs |
0.09; 0.09 | — |
| PRIMARY Induction of MDSCs |
0.09; 0.09 | — |
| PRIMARY Induction of MDSCs |
0.09; 0.09 | — |
| SECONDARY COVID-19 Infection Positive |
1; 0 | — |
| SECONDARY COVID-19 Infection Positive |
1; 0 | — |
| SECONDARY COVID-19 Infection Positive |
1; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
| SECONDARY Health Questionnaire |
0; 0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04475081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.