Study to evaluate the ability of a sublingual vaccine to induce the expression of trained immunity in peripheral blood cells

Start 31 Mar 2023 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol MV130-SLG-039

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruiting

Participants planned 48

Countries 1

Sites 1

Healthy adult males and non-pregnant females

Key facts

Sponsor: Inmunotek S.L.
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Health Care [N] - Population Characteristics [N01]
Trial duration: 31 Mar 2023 → ongoing
Decision date (initial): 2024-10-30
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-516720-34-00
EudraCT number: 2021-001502-29
ClinicalTrials.gov: NCT05208060

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Healthy adult males and non-pregnant females

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Inmunotek S.L.

Sponsor organisation: Inmunotek S.L.
Address: Calle Punto Mobi 5
City: Alcala De Henares
Postcode: 28805
Country: Spain

Scientific contact point

Organisation: Inmunotek S.L.
Contact name: Miguel Casanovas

Public contact point

Organisation: Inmunotek S.L.
Contact name: Raquel Caballero

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Spain	Ongoing, recruiting	48	1
Rest of world	—	0	—

Investigational sites

Spain

1 site · Ongoing, recruiting

Hospital Clinico San Carlos

Immunology, Calle Del Profesor Martín Lagos S/n, 28040, Madrid

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
Spain	2023-03-31		2023-09-07

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-10-14	Spain	Acceptable 2024-10-30	2024-10-30