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Measles Vaccine in HCW (MV-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357028
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mukhtar, Kasr El Aini Hospital

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

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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)
Estimated Study Start Date : July 13, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357028


Locations
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Egypt
Cairo University Hospital Recruiting
Cairo, Egypt, 11559
Contact: Ahmed M Mukhtar, M.D    01114208444 ext +2    Ahmed.Mukhtar@kasralainy.edu.eg   
Sub-Investigator: Abeer Ahmed, MD         
Sub-Investigator: Mostafa Alfishawy, MD         
Sub-Investigator: Doaa Ghaith, MD         
Sub-Investigator: Marwa Rashad, MD         
Sponsors and Collaborators
Kasr El Aini Hospital
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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    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases