B/BE/25/BVW6 - Summary Notification Information Format (SNIF)Public information according to the provisions of Directive 2001/18/EC
Long title
A phase 1, placebo-controlled, randomised, participant- and assessor-blind, single-centre study to assess the safety and immunogenicity of 2 dosages of Nipah measles vector vaccine (MV-NiV) administered subcutaneously either a single dose or as 2 consecutive doses at 4-week interval, in healthy non-exposed volunteers, aged 18-40 years
Date receipt dossier
EU record number
B/BE/25/BVW6
EudraCT number
CT 2025-522293-37-00
Company / Sponsor
University of Tokyo
Phase
I
Treated organism
Humans
Indication category
Vaccination
Disease
Nipah and Measles viruses
Therapeutic approach
Prevention
Genetic modification
A live attenuated virus (LAV)-MV-NiV, including the full genome of a live-attenuated measles virus (MV) strain, genetically engineered to express the glycoprotein G of the Nipah virus.
Method of transfer of nucleic acid of interest
Live attenuated virus
Administered biological material
Genetically modified virus
Route of administration
Subcutaneous
Locations in Belgium
Center of Vaccinology (CEVAC), UZ Ghent
Nr of subjects
60 patients in Belgium
Foreseen duration
From 01/01/2026 until 31/03/2028
Type of procedure
Contained use and Deliberate release
Current status
Authorized