Clinical trial • Phase I • Infectious Disease

MV-NiV for Nipah virus infection

Phase I trial of MV-NiV for Nipah virus infection. Randomised, placebo-controlled. 60 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Nipah virus infection
Trial Stage
Phase I
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
16-01-2026
First CTIS Authorization Date
09-03-2026

Trial design

Randomised, placebo-controlled Phase I trial across 1 site in Belgium.

Randomised
Yes
Comparator
Placebo
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
60

Recruitment

Planned Sample Size
60
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Belgium

Earliest CTIS Part Ii Submission Date
20-02-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
46
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Center for Vaccinology (CEVAC)
Principal Investigator Name
Isabel Leroux-Roels
Principal Investigator Email
isabel.lerouxroels@uzgent.be
Contact Person Name
Isabel Leroux-Roels
Contact Person Email
isabel.lerouxroels@uzgent.be
Number Of Participants
60

Sponsor

Primary sponsor

Full Name
Teikyo University
Organisation Type
Educational Institution
Country Of Registered Address
Japan

Investigational products

Investigational Product Name
Nipah measles vector (MV-NiV) vaccine (MV-NIV-001)
Active Substance
MV-NiV
Modality
Vaccine
Routes Of Administration
Subcutaneous
Route
subcutaneously
Dose Levels
2 dose levels
Frequency
Single dose or 2 consecutive doses at 4-week interval

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