An Experimental Medicine multicenter Trial to evaluate the safety and immunogenicity of experimental versus authorized SARS-CoV-2 vaccine candidates as a booster dose in healthy participants previously vaccinated with authorized mRNA SARS-CoV-2 vaccines.

Start 4 May 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol ANRS0711s SOLVE-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 48

Countries 1

Sites 2

healthy participants

Key facts

Sponsor: ANRS Maladies Infectieuses Emergentes
Participant type: Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Virus Diseases [C02]
Trial duration: 4 May 2026 → ongoing
Decision date (initial): 2026-01-21
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 participants

Version	Level	Code	Term	System organ class
28.0	PT	10084458	COVID-19 prophylaxis	100000004865

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ANRS Maladies Infectieuses Emergentes

Sponsor organisation: ANRS Maladies Infectieuses Emergentes
Address: 101 Rue De Tolbiac
City: Paris
Postcode: 75013
Country: France

Scientific contact point

Organisation: ANRS Maladies Infectieuses Emergentes
Contact name: Yves Levy

Public contact point

Organisation: ANRS Maladies Infectieuses Emergentes
Contact name: Alizee PERROT

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	32	2
Rest of world Switzerland	—	16	—

Investigational sites

France

2 sites · Ongoing, recruiting

CHU Henri Mondor

Service d'immunologie clinique et de maladies infectieuses, 1 rue Gustave Eiffel, 94010, Créteil Cedex

Groupe Hospitalier Cochin Saint Vincent de Paul

CIC 1417 Cochin Pasteur, 27 rue du Faubourg Saint Jacques, 75679 Paris cedex 14, 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	2026-05-04		2026-05-13

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-08-04	France	Acceptable 2026-01-19	2026-01-21
2	SUBSTANTIAL MODIFICATION	SM-1	2026-02-04	France	Acceptable 2026-02-19	2026-02-19