Measles Vaccine in HCW

Phase 3

Suspended

• Conditions: Covid19
• Interventions: Drug: Measles-Mumps-Rubella Vaccine; Drug: Placebos

• Registration Number: NCT04357028
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-22
• Study Start: 2020-07-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-22
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMR vaccine	Measles-Mumps-Rubella Vaccine	0.5 ml subcutaneous of MMR vaccine will be injected in posterior triceps aspect of upper arm
Control	Placebos	0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cairo University Hospital; 🇪🇬 Cairo, Egypt