Vaccination with V-212 to prevent pneumococcal disease in healthy adults

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.

This study is testing a new vaccine called V-212 to see if it can safely protect healthy adults from pneumonia caused by a common bacteria.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Virometix (Industry-sponsored)
• Locations: 1 site (Ghent)
• Trial ID: NCT06975319 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immune response of a novel vaccine, V-212, designed to protect against infections caused by Streptococcus pneumoniae. Conducted as a randomized, double-blind, placebo-controlled trial, it will administer three different doses of the vaccine to healthy adult volunteers aged 18-45. The study aims to identify the optimal dose while monitoring for any adverse effects and assessing the vaccine's immunogenicity. A total of 60 participants will be enrolled at a single center in Belgium.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-45 with no significant medical history.

Not a fit: Patients with existing health conditions or those outside the age range of 18-45 may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new preventive measure against pneumococcal disease, potentially benefiting vulnerable populations in the future.

How similar studies have performed: While this approach is novel, previous studies have shown promise in developing vaccines targeting conserved regions of bacteria, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Written signed informed consent obtained before any trial-related activities.
2. Healthy male and females aged between 18-45 years inclusive.
3. 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.
4. Capable of meeting and complying with the requirements of the trial.
5. 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:

   1. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
   2. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
   3. intrauterine device (IUD)
   4. intrauterine hormone-releasing system ( IUS)
   5. bilateral tubal occlusion
   6. vasectomised partner
   7. sexual abstinence
6. Levels of baseline immunity

   1. 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.
   2. 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.
   3. 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.
7. Subject agrees not to participate in another interventional trial while participating in the present trial.

Exclusion Criteria:

1. Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
2. Presence of any tattoos on the injection site which make evaluation of the injection site impossible.
3. Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
4. 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).
5. 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.
6. An uncontrolled or poorly controlled active respiratory disease requiring medication.
7. Administration of systemic immunosuppressant or immuno-modifying drugs within the three month period, prior to trial start.
8. Confirmed or suspected (at the discretion of the Investigator) immune-suppressive or immune-deficient condition.
9. Current smokers. Ex-smokers must have discontinued at least 1 year or more prior to trial start.
10. Blood transfusion, blood product, immunoglobulins, received during the period of 3 months prior to trial start.
11. 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.
12. 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.
13. 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).
14. Pregnant or plan to become pregnant during the trial period.
15. Breastfeeding.
16. 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.
17. History of any reaction or hypersensitivity likely to be exacerbated by any component of the investigational vaccine.
18. Alcohol, prescription drug, or substance use/abuse that, in the opinion of the Investigator, might interfere with the trial conduct or completion.
19. Medical condition or use of medication(s) that can increase the risk of bleeding or haematoma from the blood sampling and intramuscular injection.
20. 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.

Where this trial is running

Ghent

• Center for Vaccinology (CEVAC), Ghent University Hospital — Ghent, Belgium (Recruiting)

Study contacts

• Principal investigator: Isabel Leroux-Roels, Professor, Dr. — Center for Vaccinology (CEVAC), Ghent University Hospital
• Study coordinator: Isabel Leroux-Roels, Professor, Dr.

Conditions Healthy; Immunisation Against Streptococcus Pneumoniae; Healthy volunteer; Dose-finding; Safety; Immunogenicity; Placebo; Vaccination