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Measles Vaccine in HCW (MV-COVID19)

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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

Tracking Information
First Submitted Date  ICMJE April 19, 2020
First Posted Date  ICMJE April 22, 2020
Last Update Posted Date July 16, 2020
Estimated Study Start Date  ICMJE July 13, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measles Vaccine in HCW
Official Title  ICMJE Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Measles-Mumps-Rubella Vaccine
    Measles mumps Rubella vaccine is a weak attenuated life vaccine
  • Drug: Placebos
    0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
Study Arms  ICMJE
  • Experimental: MMR vaccine
    0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm
    Intervention: Drug: Measles-Mumps-Rubella Vaccine
  • Placebo Comparator: Control
    0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04357028
Other Study ID Numbers  ICMJE N-30-2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Mukhtar, Kasr El Aini Hospital
Study Sponsor  ICMJE Kasr El Aini Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kasr El Aini Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP