Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
240
Countries
1
Sites
12
Healthy volunteers
Key facts
- Sponsor
- Inserm
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 6 Jan 2025 → ongoing
- Decision date (initial)
- 2023-10-12
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10084268 | COVID-19 | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Inserm
- Sponsor organisation
- Inserm
- Address
- 101 Rue De Tolbiac
- City
- Paris
- Postcode
- 75013
- Country
- France
Scientific contact point
- Organisation
- Inserm
- Contact name
- Diana Molino
Public contact point
- Organisation
- Inserm
- Contact name
- Diana Molino
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 215 | 12 |
| Rest of world
Switzerland
|
— | 25 | — |
Investigational sites
Hospital Hotel Dieu
CHU Nantes / CIC 1413, 1 Place Alexis Ricordeau, 44000, Nantes
Chu De Saint Etienne
Infectious Diseases Department Hôpital Nord-CHU Saint Etienne, 25 Boulevard Pasteur, 42055, Saint-Etienne Cedex 2
CHU De Rouen
CHU Rouen / CIC-CRB 1404, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Rennes
CIC 1414 Rennes, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Montpellier
CHU Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hopital Saint Antoine
Service des maladies infectieuses et tropicales, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Assistance Publique Hopitaux De Paris
CIC1417 Paris Cochin, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Assistance Publique Hopitaux De Paris
Department of Infectious Diseases & Clinical Immunology, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire De Dijon
CIC 1432 CHU DIJON-BOURGOGNE, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Nimes
Service Maladies Infectieuses, CHU Nîmes, Place Du Professeur Robert Debre, 30900, Nimes
Hopital De La Croix Rousse
Hospital de Lyon Nord – Croix Rousse, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Hopital Saint Louis
CIC1427, 1 Avenue Claude Vellefaux, 75010, Paris
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-04-29 | 2024-05-27 | 2026-03-17 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-65171
- Halt date
- 2024-12-13
- Planned restart
- 2025-01-06
- Member states concerned
- France
- Publication date
- 2025-01-03
- Reason
- Study management related
- Explanation
- On 13 December 2024 an event a 'severe' non-serious adverse event was reported in the LD CD40.RBDv vaccine Hiltonol -adjuvanted cohort. Previously, another 'severe' non-serous adverse reactions had been reported in another participant included in the same cohort, bringing the number of 'severe' non-serious adverse reactions to two.
In accordance with the applicable protocol V4.0 :
"if a ‘severe’ non-serious adverse reactions occurs in at least two subjects in the same cohort, during any stage of the study, all vaccinations will be halted, inclusions in the trial will be suspended, competent authorities must be informed and an ad hoc DSMB meeting convened for recommendations on the trial continuation."
We have therefore immediately suspended inclusions and injections and have scheduled a DSMB meeting to be held on 20 december 2024 - Follow-up measures
- Scheduling of a DSMB meeting for 20 december 2024 to seek the DSMB's advice on the continuation of the study and the restart of participant inclusions.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-03 | France | Acceptable 2023-10-12
|
2023-10-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-06 | France | Acceptable | 2023-12-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-12 | France | Acceptable 2023-12-22
|
2023-12-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-06-07 | France | Acceptable 2024-07-15
|
2024-07-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-21 | France | Acceptable 2024-11-26
|
2024-11-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-02-24 | France | Acceptable 2025-04-30
|
2025-05-05 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-20 | France | Acceptable | 2025-07-24 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | France | Acceptable | 2025-09-02 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-20 | France | Acceptable | 2025-11-20 |