HealthyEarly Phase 1NCT06975319
Phase I Study With V-212 Vaccinations in Healthy Adult Volunteers
A Early Phase 1 study of Healthy and Immunisation Against Streptococcus Pneumoniae, run by Virometix at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Immunisation Against Streptococcus Pneumoniae
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jan 2025to 10 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written signed informed consent obtained before any trial-related activities.
- Healthy male and females aged between 18-45 years inclusive.
- No evidence of clinically significant disease based on medical his-tory, physical examination, vital signs (blood pressure, heart rate, body temperature), laboratory safety parameters and clinical judgement.
- Capable of meeting and complying with the requirements of the trial.
- Female subjects of childbearing potential should have a negative serum pregnancy test at screening and must agree to use highly effective and acceptable contraceptive measures (as per the HMA/CTFG recommendations) 60 days before trial entry and during the active phase of the trial up to 2 months after the last dose (Day 150). Contraceptive measures considered adequate are:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
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- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
- Levels of baseline immunity
- Subjects demonstrating baseline levels of immunity against V-212 epitopes that correspond to an OD450 value of below 0.8, when the ELISA IgG determination assay is performed with a serum sample at a 1:300 dilution.
- Subjects demonstrating baseline levels of immunity against one epitope that correspond to an OD450 value of below 2.0, while at the same time baseline levels of immunity against a second epitope are below 0.8, when the ELISA IgG determination assay is similarly performed.
- Subjects demonstrating baseline levels of immunity against one epitope that correspond to an OD450 value of below 2.0, while at the same time baseline levels of immunity against a second epitope are below 0.8, when the ELISA IgG determination assay is similarly performed.
- Subject agrees not to participate in another interventional trial while participating in the present trial.
Who cannot join
- Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
- Presence of any tattoos on the injection site which make evaluation of the injection site impossible.
- Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
- Presence of serologic markers of acute or chronic Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAG and anti-HBc) and Hepatitis C Virus (anti-HCV) infections(s).
- Any chronic disease, or history of significant disease that might interfere with the trial's conduct or completion. Some conditions may be accepted if stabilised, e.g. hypertension, based on clinical judgement.
- An uncontrolled or poorly controlled active respiratory disease requiring medication.
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- Administration of systemic immunosuppressant or immuno-modifying drugs within the three month period, prior to trial start.
- Confirmed or suspected (at the discretion of the Investigator) immune-suppressive or immune-deficient condition.
- Current smokers. Ex-smokers must have discontinued at least 1 year or more prior to trial start.
- Blood transfusion, blood product, immunoglobulins, received during the period of 3 months prior to trial start.
- Clinically significant (according to Investigator's judgement) out of range laboratory values (referring to the FDA Guidance for Toxicity Grading Scale for volunteers in vaccine trials). The ab-normal lab test can be neglected if its cause is evident and of no clinical relevance.
- Acute disease and/or fever (≥38°C measured by the oral route) at the time of IMP administration. Vaccine administration can be postponed until the febrile episode is over.
- Recent vaccination (e.g., vaccine administration within 2 weeks (inactivated) or 4 weeks (live attenuated)) before each vaccination or evidence that a vaccine will be required during the trial period (e.g., planned travel).
- Pregnant or plan to become pregnant during the trial period.
- Breastfeeding.
- Any other significant finding including a history of serious reactions to vaccines, that would increase, according to the Investigator, the risk of having an adverse outcome from participating in the trial.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the investigational vaccine.
- Alcohol, prescription drug, or substance use/abuse that, in the opinion of the Investigator, might interfere with the trial conduct or completion.
- Medical condition or use of medication(s) that can increase the risk of bleeding or haematoma from the blood sampling and intramuscular injection.
- Subjects employed by the Sponsor, by the vendors working on behalf of the Sponsor, by the Investigator or the trial site, or close relatives of research staff working on this trial.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center for Vaccinology (CEVAC), Ghent University Hospital
Ghent, 9000
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low dose, V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium dose, V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high dose
- Keywords
- Healthy volunteer, Dose-finding, Safety, Immunogenicity, Placebo, Vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low doseBiological
V-212 is a peptide antigen-based vaccine.
V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium doseBiological
V-212 is a peptide antigen-based vaccine.
V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high doseBiological
V-212 is a peptide antigen-based vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose (LD) Cohort | Experimental | Low Dose (LD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. Receives: Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low dose |
| Intermediate Dose (MD) Cohort | Experimental | Intermediate Dose (MD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. Receives: Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium dose |
| High Dose (HD) Cohort | Experimental | High Dose (HD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. Receives: Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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).
Measured: From enrollment to the end of treatment at month 4 and during follow-up until month 12.
Secondary outcomes (1)
To assess the immunogenicity of vaccination with V-212
Determination of epitope specific levels of anti-V-212 antibodies using V-212 IgG ELISA
Measured: From enrollment to the end of treatment at month 4 and at month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start29 Jan 2025
- Primary completion2 Dec 2025
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 (IM) injections of V-212 vaccine or placebo. Within each cohort there will be two times sentinel dosing applied (two subjects receive a single dose of the active IMP V-212 and one subject receives placebo). 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virometix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CR2O
- Responsible party
- Sponsor
- Investigators
- Isabel Leroux-Roels, Professor, Dr., Principal investigator, Center for Vaccinology (CEVAC), Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975319
- Sponsor's protocol ID
- VMX-SPN-212-001
- Other IDs
- 2024-516008-41-00
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06975319
- Acronym / sponsor ID
- VMX-SPN-212-001
- Keywords
- Healthy volunteer, Dose-finding, Safety, Immunogenicity, Placebo, Vaccination
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VirometixIndustry (pharma, biotech, devices)
- Collaborators
- CR2O
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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 (IM) injections of V-212 vaccine or placebo. Within each cohort there will be two times sentinel dosing applied (two subjects receive a single dose of the active IMP V-212 and one subject receives placebo). 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.
| Arm | Type | Receives |
|---|---|---|
| Low Dose (LD) Cohort | Experimental | Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low doseLow Dose (LD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. |
| Intermediate Dose (MD) Cohort | Experimental | Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium doseIntermediate Dose (MD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. |
| High Dose (HD) Cohort | Experimental | Biological: V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high doseHigh Dose (HD) Cohort with 20 subjects; 15 will be vaccinated with V-212 and 5 subjects with placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Written signed informed consent obtained before any trial-related activities.
- Healthy male and females aged between 18-45 years inclusive.
- No evidence of clinically significant disease based on medical his-tory, physical examination, vital signs (blood pressure, heart rate, body temperature), laboratory safety parameters and clinical judgement.
- Capable of meeting and complying with the requirements of the trial.
- Female subjects of childbearing potential should have a negative serum pregnancy test at screening and must agree to use highly effective and acceptable contraceptive measures (as per the HMA/CTFG recommendations) 60 days before trial entry and during the active phase of the trial up to 2 months after the last dose (Day 150). Contraceptive measures considered adequate are:
Key exclusion criteria (20 listed)
- Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
- Presence of any tattoos on the injection site which make evaluation of the injection site impossible.
- Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
- Presence of serologic markers of acute or chronic Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAG and anti-HBc) and Hepatitis C Virus (anti-HCV) infections(s).
- Any chronic disease, or history of significant disease that might interfere with the trial's conduct or completion. Some conditions may be accepted if stabilised, e.g. hypertension, based on clinical judgement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V-212 (or Placebo) administered by i.m injection (3 vaccinations) - low doseV-212 is a peptide antigen-based vaccine. | Biological | Low Dose (LD) Cohort |
| V-212 (or Placebo) administered by i.m injection (3 vaccinations) - medium doseV-212 is a peptide antigen-based vaccine. | Biological | Intermediate Dose (MD) Cohort |
| V-212 (or Placebo) administered by i.m injection (3 vaccinations) - high doseV-212 is a peptide antigen-based vaccine. | Biological | High Dose (HD) Cohort |
Primary outcome
(Serious) adverse events
Time frame: From enrollment to the end of treatment at month 4 (incl. subject diary data collection) and during follow-up until month 12.
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).
Solicited local and systemic adverse events
Time frame: During 7 days post-each administration
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).
Laboratory safety parameters (hematology & biochemistry)
Time frame: From enrollment to the end of treatment at month 4.
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
Vital signs
Time frame: From enrollment to the end of treatment at month 4 and during follow-up until month 12.
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).
Physical examination
Time frame: From enrollment to the end of treatment at month 4 and during follow-up until month 12.
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).
1 secondary outcome
To assess the immunogenicity of vaccination with V-212
Time frame: From enrollment to the end of treatment at month 4 and at month 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Leroux-Roels, Professor, Dr. principal investigator
Center for Vaccinology (CEVAC), Ghent University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Healthy and Immunisation Against Streptococcus Pneumoniae, run by Virometix at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Serious) adverse events (time frame: From enrollment to the end of treatment at month 4 (incl. subject diary data collection) and during follow-up until month 12.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.