MV-COVID19: Measles Vaccine in HCW

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Suspended

CT.gov ID

NCT04357028

Collaborator

(none)

200

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

35.4

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jul 13, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Jan 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

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

COVID-19 disease incidence [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

SARS-CoV-2 pneumonia [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: 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: 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

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Cairo University Hospital	Cairo		Egypt	11559

Sponsors and Collaborators

Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Apr 22, 2020

Last Update Posted:

Dec 22, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Mukhtar, professor of anesthesia and intensive care, Kasr El Aini Hospital

MMR vaccine, Respiratory failure,

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Dec 22, 2020