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

NCT04475081 | Completed Phase 3 Results FDA Drug

• 1 other identifier: PF-1214
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Syndrome

Keywords

MMR vaccine; COVID-19; Sepsis; trained innate immunity; myeloid-derived suppressor cells; inflammation

Outcome Measures

Primary Outcomes (3)

• Induction of MDSCs

  peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

  30 days post vaccination

• Induction of MDSCs

  peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

  60 days post vaccination

• Induction of MDSCs

  peripheral blood monocytic MDSCs (M-MDSC) and/or granulocytic MDSCs (G-MDSC) determined by flow cytometry from whole blood samples as percentage/fold change over baseline

  12 months post vaccination

Secondary Outcomes (16)

• COVID-19 Infection Positive

  30 days post-vaccination

• COVID-19 Infection Positive

  60 days post-vaccination

• COVID-19 Infection Positive

  12 months post-vaccination

• Health Questionnaire

  14 days post-vaccination

• Health Questionnaire

  30 days post-vaccination

Study Arms (2)

MMR vaccination

EXPERIMENTAL

Subjects will be randomized to receive the MMR Vaccine subcutaneously

Biological: MMR vaccine

Placebo control

PLACEBO COMPARATOR

Subjects will be randomized to receive sterile saline given subcutaneously

Biological: MMR vaccine

Interventions

MMR vaccine BIOLOGICAL

Merck MMR-II vaccine

MMR vaccination; Placebo control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Parsemus Foundation: collaborator

Study Sites (1)

Clinical and Translational Research Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (2)

• Fidel PL Jr, Noverr MC. Could an Unrelated Live Attenuated Vaccine Serve as a Preventive Measure To Dampen Septic Inflammation Associated with COVID-19 Infection? mBio. 2020 Jun 19;11(3):e00907-20. doi: 10.1128/mBio.00907-20.

  PMID: 32561657 BACKGROUND

• Noverr MC, Yano J, Hagensee ME, Lin HY, Meyaski MC, Meyaski E, Cameron J, Shellito J, Trauth A, Fidel PL Jr. Effect of MMR Vaccination to Mitigate Severe Sequelae Associated With COVID-19: Challenges and Lessons Learned. Med Res Arch. 2023 Feb;11(2):3598. doi: 10.18103/mra.v11i2.3598.

  PMID: 37153751 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; COVID-19; Sepsis; Inflammation

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Results Point of Contact

• Title: Associate Dean for Research
• Organization: Louisiana State University Health - New Orleans

pfidel@lsuhsc.edu

9858693445

Study Officials

• Paul L Fidel, PhD

  Louisiana State University Health Sciences Center - New Orleans

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomized by study nurse
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Model Details: MMR vaccine vs placebo

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: September 22, 2020
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years
• Access Criteria: If fully justified for additional research purposes

Locations

US (1)