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Measles Vaccine in HCW (MV-COVID19)

Primary Purpose

Covid19

Status
Suspended
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Measles-Mumps-Rubella Vaccine
Placebos
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring MMR vaccine, Respiratory failure,

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MMR vaccine

Control

Arm Description

0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm

0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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

Full Information

First Posted
April 19, 2020
Last Updated
December 18, 2020
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04357028
Brief Title
Measles Vaccine in HCW
Acronym
MV-COVID19
Official Title
Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Suspended
Why Stopped
Failure of subject recruitment
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
MMR vaccine, Respiratory failure,

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMR vaccine
Arm Type
Experimental
Arm Description
0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
Intervention Type
Drug
Intervention Name(s)
Measles-Mumps-Rubella Vaccine
Intervention Description
Measles mumps Rubella vaccine is a weak attenuated life vaccine
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
Primary Outcome Measure Information:
Title
COVID-19 disease incidence
Description
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
Time Frame: Measured over the 6 months following randomization
Secondary Outcome Measure Information:
Title
SARS-CoV-2 pneumonia
Description
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
Time Frame: Measured over the 6 months following randomization
Title
Critical care admission duration with SARS-CoV-2
Description
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
Time Frame: Measured over the 6 months following randomization
Title
Oxygen therapy with SARS-CoV-2
Description
Need for oxygen therapy (using self-reported questionnaire and/or medical/hospital records) associated with a positive SARS-CoV-2 test
Time Frame
Time Frame: Measured over the 6 months following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Cairo University Hospital
City
Cairo
ZIP/Postal Code
11559
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Measles Vaccine in HCW

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