Measles Vaccine in HCW

NCT04357028 | Suspended Phase 3 DMC

• 1 other identifier: N-30-2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

MMR vaccine, Respiratory failure,

Outcome Measures

Primary Outcomes (1)

• 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)

  Time Frame: Measured over the 6 months following randomization

Secondary Outcomes (3)

• SARS-CoV-2 pneumonia

  Time Frame: Measured over the 6 months following randomization

• Critical care admission duration with SARS-CoV-2

  Time Frame: Measured over the 6 months following randomization

• Oxygen therapy with SARS-CoV-2

  Time Frame: Measured over the 6 months following randomization

Study Arms (2)

MMR vaccine

EXPERIMENTAL

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

Drug: Measles-Mumps-Rubella Vaccine

Control

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Measles-Mumps-Rubella Vaccine DRUG

Measles mumps Rubella vaccine is a weak attenuated life vaccine

MMR vaccine

Placebos DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospital

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of anesthesia and intensive care

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: July 13, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 1, 2021
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)