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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Induction of MDSCs

Timeframe: 30 days post vaccination

Induction of MDSCs

Timeframe: 60 days post vaccination

Induction of MDSCs

Timeframe: 12 months post vaccination

Trial details

NCT IDNCT04475081

SponsorLouisiana State University Health Sciences Center in New Orleans

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-15

Results submitted2023-12-08

View on ClinicalTrials.gov More Sepsis Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.