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Phase I Study With V-212 Vaccinations in Healthy Adult Volunteers

NCT06975319 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-26

No results posted yet for this study

Summary

Virometix AG, is conducting research into a vaccine (V-212) to prevent pneumococcal disease, which is any type of illness caused by infection with a bacterium called Streptococcus pneumoniae (S. pneumoniae).

This trial is being conducted to obtain insight into the body's immune response and possible adverse effects of the trial vaccine in healthy adult volunteers. Three different doses will be evaluated to identify an optimal dose for future trials.

The trial is a prospective (collects data into the future), randomised, double-blind, phase I, first in human, placebo-controlled trial which will be conducted at one centre in Belgium. A total of 60 trial participants will be enrolled.

Conditions

  • Healthy
  • Immunisation Against Streptococcus Pneumoniae

Interventions

BIOLOGICAL

V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low dose

V-212 is a peptide antigen-based vaccine.

BIOLOGICAL

V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium dose

V-212 is a peptide antigen-based vaccine.

BIOLOGICAL

V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high dose

V-212 is a peptide antigen-based vaccine.

Sponsors & Collaborators

  • CR2O

    collaborator UNKNOWN

  • Virometix

    lead INDUSTRY

Principal Investigators

  • Isabel Leroux-Roels, Professor, Dr. · Center for Vaccinology (CEVAC), Ghent University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2025-12-02
Completion
2026-07-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975319 on ClinicalTrials.gov