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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
V-212 is a peptide antigen-based vaccine.
V-212 is a peptide antigen-based vaccine.
V-212 is a peptide antigen-based vaccine.
Center for Vaccinology (CEVAC), Ghent University Hospital
Ghent, Belgium
(Serious) adverse events
Number and percentage of subjects reporting (serious) adverse events and pregnancies. Incidence rates from the time of administration through 30 days post-administration, by treatment (vaccine/placebo) group and by cohort (dose). Descriptive analyses will be performed for the 7- and 30-day periods following each administration. (Serious) adverse events will be recorded in a subject diary incl. concomitant medication from enrollment until month 4. Causality and duration (start/stop date and time) will be recorded. SAEs (and pregnancies) will be followed up until month 12 and described using narratives. Intensity assessments will be based on FDA guideline for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials incl. 4 severity levels: mild, moderate, severe, or potentially life threatening (grade 1 to 4).
Time frame: From enrollment to the end of treatment at month 4 (incl. subject diary data collection) and during follow-up until month 12.
Solicited local and systemic adverse events
Number and percentage of subjects reporting solicited local and systemic AEs reported in a subject diary. Incidence rates from the time of administration through 30 days post-administration, by treatment (vaccine/placebo) group and by cohort (dose). Descriptive analyses will be performed for the 7- and 30-day periods following each administration. Local solicited symptoms are pain, induration (cm) , erythema (cm) and swelling (cm). Systemic solicited symptoms are headache, fatigue, body temperature (measured orally in Celsius), generalised myalgia. Intensity assessments will be based on FDA guideline for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials incl. 4 severity levels: mild, moderate, severe, or potentially life threatening (grade 1 to 4).
Time frame: During 7 days post-each administration
Laboratory safety parameters (hematology & biochemistry)
Number and percentage of subjects presenting with safety laboratory abnormalities (hematology \& biochemistry - in international units) considered clinically significant. Evaluated and presented in a descriptive way with comparisons made by treatment (vaccine/placebo) group and by cohort (dose) versus baseline. Intensity assessments will be based on FDA guideline for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials incl. 4 severity levels: mild, moderate, severe, or potentially life threatening (grade 1 to 4).x
Time frame: From enrollment to the end of treatment at month 4.
Vital signs
Number and percentage of subjects with vital sign modifications. Evaluated and presented in a descriptive way with comparisons made by treatment (vaccine/placebo) group and by cohort (dose) versus baseline. Vital sign measurements include: height (cm), weight (kg), oral temperature (Celsius), BMI (kg/m2), heart rate (bts/min), and blood pressure (mmHg). Oral body temperature will be assessed per subject eDiary during the 7 days after each administration. Intensity assessments will be based on FDA guideline for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials incl. 4 severity levels: mild, moderate, severe, or potentially life threatening (grade 1 to 4).
Time frame: From enrollment to the end of treatment at month 4 and during follow-up until month 12.
Physical examination
Number and percentage of subjects with abnormalities detected at the time of physical examination. Evaluated and presentation in a descriptive way with comparisons made by treatment (vaccine/placebo) group and by cohort (dose) versus baseline. Intensity assessments will be based on FDA guideline for toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials incl. 4 severity levels: mild, moderate, severe, or potentially life threatening (grade 1 to 4).
Time frame: From enrollment to the end of treatment at month 4 and during follow-up until month 12.
To assess the immunogenicity of vaccination with V-212
Determination of epitope specific levels of anti-V-212 antibodies using V-212 IgG ELISA
Time frame: From enrollment to the end of treatment at month 4 and at month 12.
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