NCT05758532

Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children

Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection With Unrelated Pathogens and Allergic Diseases - a Single-centre Phase IV RCT With a Factorial Design

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Laure Pittet, MD-PhD · Academic / Other
• Sex: All
• Age: 6 Months – 6 Months
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.

Detailed description

The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes. The current Swiss administration schedule of giving MMR at 9 and 12 months of age ("current schedule") will be compared with a "modified schedule". This is expected to maximise the beneficial non-specific effects of MMR by giving it at 6 and 13 months of age, separately from other vaccines ("modified schedule"). Factorial analysis will enable assessment of the benefit of the intervention on each of the two doses of MMR separately or in combination. The clinical aims are to determine whether a modified schedule of MMR administration reduces both the risk and severity of: (i) infections with unrelated pathogens and (ii) atopic and allergic diseases. The laboratory aims are to: (i) quantify and characterise the immunological non-specific effects of MMR, and (ii) identify the biological pathways and molecular mechanisms that are altered by MMR vaccination.

Conditions

• Respiratory Tract Infections
• Infections
• Allergy
• Eczema

Interventions

Type	Name	Description
BIOLOGICAL	Measles-Mumps-Rubella vaccine (MMR)	0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh

Timeline

• Start date: 2023-03-17
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2023-03-07
• Last updated: 2024-05-29

Locations

1 site across 1 country: Switzerland