A first-in-human phase 1, single center, randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of three dose levels of the OVX033 vaccine, after intramuscular administration in healthy subjects aged 18-49 years

2023-506396-94-00 Protocol OVX033-001 Human pharmacology (Phase I) - First administration to humans Ended

Start 8 Jan 2024 · End 29 Nov 2024 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol OVX033-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Ended
Participants planned 48
Countries 1
Sites 1

Sarbecovirus diseases

Key facts

Sponsor
Osivax
Participant type
Healthy volunteers
Age range
18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
8 Jan 2024 → 29 Nov 2024
Decision date (initial)
2023-11-30
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Sarbecovirus diseases

VersionLevelCodeTermSystem organ class
23.0 PT 10051905 Coronavirus infection 100000004862

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Osivax

3 Total trials 2 Ended
Commercial
Sponsor organisation
Osivax
Address
70 Rue Saint Jean De Dieu
City
Lyon
Postcode
69007
Country
France

Scientific contact point

Organisation
Osivax
Contact name
Florence Nicolas - Chief Development Officer

Public contact point

Organisation
Osivax
Contact name
Florence Nicolas - Chief Development Officer

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ended 48 1
Rest of world — 0 —

Investigational sites

France

1 site · Ended
Assistance Publique Hopitaux De Paris
Centre d'Investigation Clinique Cochin-Pasteur -CIC1417, 27 Rue Du Faubourg Saint Jacques, 75014, Paris

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2024-01-08 2024-11-29 2024-01-08 2024-06-07

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-19 France Acceptable
2023-11-15
 2023-11-30
2 NON SUBSTANTIAL MODIFICATION NSM-2 2024-01-12 France Acceptable
2023-11-15
 2024-01-12
3 NON SUBSTANTIAL MODIFICATION NSM-3 2024-04-09 Acceptable
2023-11-15
4 SUBSTANTIAL MODIFICATION SM-1 2024-05-02 France Acceptable 2024-06-03
5 NON SUBSTANTIAL MODIFICATION NSM-5 2024-06-04 France 2024-06-04
6 SUBSTANTIAL MODIFICATION SM-2 2024-10-28 France Acceptable
2024-11-22
 2024-12-09