Measles Vaccine in HCW (MV-COVID19)

Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)

Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV,

The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19.

We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness

Study Overview

• Status: Suspended
• Conditions: Covid19
• Intervention / Treatment: Drug: Measles-Mumps-Rubella Vaccine; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Cairo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-50 years old
• Subjects who are willing to comply with the requirements of the study protocol and scheduled visits (for example, completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study with access to a consistent means of telephone contact

Exclusion Criteria:

• acute severe illness
• recent receipt of a blood product
• history of thrombocytopenia
• Pregnant females
• any chronic medical condition
• Any participant receiving any immune suppressive medication
• Immunocompromised staff
• Participants who have egg allergy
• Participants who care for immune compromised hosts
• Participants who test positive for COVID-19 serology prior to randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMR vaccine; 0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm	Drug: Measles-Mumps-Rubella Vaccine; Measles mumps Rubella vaccine is a weak attenuated life vaccine
Placebo Comparator: Control; 0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm	Drug: Placebos; 0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 disease incidence	Number of participants with asymptomatic or mild COVID-19 disease defined as fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology)	Time Frame: Measured over the 6 months following randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 pneumonia	Number of pneumonia cases (abnormal chest X-ray) (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test	Time Frame: Measured over the 6 months following randomization
Critical care admission duration with SARS-CoV-2	Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test	Time Frame: Measured over the 6 months following randomization
Oxygen therapy with SARS-CoV-2	Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test	Time Frame: Measured over the 6 months following randomization

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: MMR vaccine, Respiratory failure,
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: N-30-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No