Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Condition: Lyme Borreliosis
MeSH terms: Borrelia Infections; Lyme Disease
Intervention: VLA15; Placebo
Intervention description: a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate; PBS (Phosphate Buffered Saline)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 625.0
Sex: All
Minimum age: 5 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: VLA15; Lyme Borreliosis; Vaccine; Lyme disease; Borrelia

Summary:

      VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A)
      and Booster Phase (Part B). The study will compare the safety and immunogenicity of two
      different primary immunization schedules applying three (Month 0-2-6) or two (Month 0-6)
      vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included.
      Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as
      Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 19
      months in Part A and additional 37 months for subjects enrolled in the Part B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is aged 5 to 65 years at the day of screening (Visit 0)

          -  Subject is of good general health

          -  Parent(s)/legal representative(s) and subject understand the study and its procedures,
             agree to its provisions

               -  for subjects aged 18-65 years: written informed consent prior to any study
                  related procedures

               -  for subjects aged 5-17 years: written informed consent by the subject's legal
                  representative(s), according to local requirements, and written informed assent
                  of the subject, if applicable, prior to any study related procedures.

          -  If subject is of childbearing potential: Subject has a negative serum pregnancy test
             at screening (Visit 0) and agrees to employ adequate birth control measures according
             to following timelines:

               -  Main Study Phase: duration of entire study

               -  Booster Phase: until Month 23 (i.e. 5 months after booster dose)

          -  Subject is willing and able to comply with scheduled visits, treatment plan, and other
             study procedures

          -  Subject is available for the duration of the study and can be contacted by telephone
             during study participation

        Exclusion Criteria:

          -  Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic
             LB, or received treatment for LB within the last 3 months prior to Day 1;

          -  Subject received previous vaccination against LB;

          -  Subject had a tick bite within 4 weeks prior to Day 1;

          -  Subject has a medical history of or currently has a clinically relevant disease;

          -  Subject has a medical history of or currently has a neuro-inflammatory or autoimmune
             disease;

          -  Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in
             the 3 weeks prior to Day 1;

          -  Subject has received an active or passive immunization within 4 weeks prior to Day 1;

          -  Subject has received any other registered or non-registered medicinal product in
             another clinical trial within 4 weeks prior to vaccination at Day 1;

          -  Subject has a known or suspected defect of the immune system or received
             immuno-suppressive therapy within 4 weeks prior to Day 1;

          -  Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of
             unknown cause or has a known hypersensitivity or allergic reactions to one of the
             components of the vaccine;

          -  Subject had any malignancy in the past 5 years;

          -  Subject is pregnant, has plans to become pregnant during the course of the study or is
             lactating at the time of enrollment;

          -  Subject has donated or plans to donate blood or blood-derived products 4 weeks prior
             to Day 1;

          -  Subject has any condition that may compromise its well-being, might interfere with
             evaluation of study endpoints, or would limit the subject's ability to complete the
             study;

          -  Subject is in a dependent relationship;