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 consecut

Study 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 consecut
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: 
8 okt 2025
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: 
Under evaluation

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