NCT06975319

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

A Prospective, Randomised, Placebo-controlled, Double-blind First in Human Trial Evaluating the Safety and Immunogenicity of V-212 Administered on Three Occasions in Healthy Adult Volunteers.

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Virometix · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Streptococcus pneumoniae (Spn) is a leading cause of a wide range of serious bacterial infections including otitis media, pneumonia, meningitis, and bacteraemia, with considerable morbidity and mortality worldwide. Prophylaxis is based on capsular polysaccharide vaccines which currently cover up to 23 serotypes. With the emergence of serotypes that are not well covered by existing vaccines (e.g. Serotypes 3 and 19A) and the increasing prevalence of non-vaccine serotypes which cannot be sustainably addressed by current vaccination strategies, there is an urgent need for an enhanced serotype-independent S. pneumoniae vaccine. V-212 is a novel peptide antigen vaccine with the potential to elicit serotype-independent protective immunity against S. pneumoniae infection by targeting conserved peptide regions found in all bacterial serotypes. This trial will evaluate the safety and immunogenicity of V-212 in healthy adults. The data generated will help establish the potential for V-212 to be further developed for vaccination of vulnerable populations such as elderly, immunocompromised, and paediatric patients. Primary trial objective: • To assess the safety and reactogenicity of vaccination with V-212 administered three times at 3 different dose levels compared with placebo. Secondary trial objective: • To assess the immunogenicity of vaccination with V-212 administered three times at 3 different dose levels compared with placebo. Exploratory trial objectives: * To assess native epitope recognition by V-212 IgG * To evaluate cellular immunity * To evaluate B-cell memory responses Subjects will be healthy adults (male and female) aged between 18 and 45 years inclusive. A total of 60 subjects will be enrolled. 45 subjects will be vaccinated with V-212, and 15 subjects will receive placebo. Each subject will receive a total of 3 intramuscular (i.m.) injections of V-212 vaccine or placebo. Within each cohort there will be sentinel dosing applied (two subjects receive a single dose of the active IMP). The enrolment of the sentinel subjects in the three cohorts will commence once at least 48 hours safety data (Day 2) have been reviewed by the investigator (and/or delegate) before the remaining subjects in the cohort will be enrolled. The duration of the trial for each subject will be approximately 14 months. The total duration of the trial will be approximately 20 months with 9 months planned for recruitment.

Conditions

• Healthy
• Immunisation Against Streptococcus Pneumoniae

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-29
• Primary completion: 2025-12-02
• Completion: 2026-07-30
• First posted: 2025-05-16
• Last updated: 2025-08-26

Locations

1 site across 1 country: Belgium