Measles Vaccine in HCW (MV-COVID19)

• ClinicalTrials.gov Identifier: NCT04357028
• Recruitment Status: Suspended
• First Posted: April 22, 2020
• Last Update Posted: December 22, 2020
• Sponsor: Kasr El Aini Hospital
• Information provided by (Responsible Party): Ahmed Mukhtar, Kasr El Aini Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: Measles-Mumps-Rubella Vaccine; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
• Actual Study Start Date: July 13, 2020
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: January 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. COVID-19 disease incidence [ Time Frame: Time Frame: Measured over the 6 months following randomization ]
   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)

Secondary Outcome Measures :

1. SARS-CoV-2 pneumonia [ Time Frame: Time Frame: Measured over the 6 months following randomization ]
   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
2. Critical care admission duration with SARS-CoV-2 [ Time Frame: Time Frame: Measured over the 6 months following randomization ]
   Number of days admitted to critical care (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
3. Oxygen therapy with SARS-CoV-2 [ Time Frame: Time Frame: Measured over the 6 months following randomization ]
   Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Egypt

Cairo University Hospital

Cairo, Egypt, 11559

Sponsors and Collaborators

Kasr El Aini Hospital

More Information

• Responsible Party: Ahmed Mukhtar, professor of anesthesia and intensive care, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT04357028
• Other Study ID Numbers: N-30-2020
• First Posted: April 22, 2020
• Last Update Posted: December 22, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed Mukhtar, Kasr El Aini Hospital:

MMR vaccine, Respiratory failure,

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases