Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.
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; Placebo: 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: 572.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: VLA15, Lyme Borreliosis, Vaccine

Summary:

      This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted
      in two study phases: a run-in phase and a main study phase. The study was investigated 3
      doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy
      adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine
      at a monthly interval. The study assessed the immune response as well as the safety profile
      of the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

        Run-in phase:

        1. Subject is aged 18 to 40 years at the day of screening (Visit 0);

        Main Study phase:

          1. Subject is aged18 to 65 years at the day of screening (Visit 0);

             Run-in phase and Main Study phase:

          2. Subject is of good general health, including subjects with pharmacologically
             controlled chronic conditions;

          3. Subject has an understanding of the study and its procedures, agrees to its
             provisions, and gives written informed consent prior to any study-related procedures;

          4. If subject is of childbearing potential:

               1. Subject has a negative serum pregnancy test at screening (Visit 0);

               2. Subject agrees to employ adequate birth control measures for the duration of the
                  study.

        Exclusion Criteria:

          1. Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic
             LB (Lyme borreliosis) as suspected or diagnosed by a physician, or received treatment
             for LB (Lyme borreliosis) within the last 3 months prior to Visit 0;

          2. Subject received previous vaccination against Lyme borreliosis (LB).;

          3. Subject had a tick bite within 4 weeks prior to Visit 1;

          4. Subject has a medical history of or currently has a clinically relevant disease
             (cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk
             for participation in the study, based on investigators judgement, such as individuals
             with poorly controlled or unstable disease, ongoing suspected or active inflammation,
             or poor compliance with pharmacologic treatment. Subjects with pharmacologically
             controlled conditions like osteoarthritis, depression, or asthma are eligible;

          5. Subject has a medical history of or currently has a neuroinflammatory or autoimmune
             disease, including Guillain Barré Syndrome;

          6. Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in
             the 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating
             intramuscular vaccination as judged by the investigator;

          7. Subject has received an active or passive immunization within 28 days before first
             vaccination at Visit 1 and until Day 85; except for influenza (seasonal or pandemic)
             and pneumococcal vaccines which may be administered outside a 7-days interval before
             or after any trial vaccination;

          8. Subject has received any other non-registered medicinal product in another clinical
             trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and throughout the
             entire study period or has received a registered medicinal product in another clinical
             trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and up to Day 85;

          9. Subject has a known or suspected defect of the immune system that would prevent an
             immune response to the vaccine, such as subjects with congenital or acquired
             immunodeficiency, including infection with human immunodeficiency virus (HIV), status
             post organ transplantation or immuno-suppressive therapy within 30 days prior to Visit
             1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14
             days) prednisone or equivalent 0.05 mg per kg/ per day. Topical and inhaled steroids
             are allowed;

         10. Subject has a history of anaphylaxis or severe allergic reactions or a known
             hypersensitivity or allergic reactions to one of the components of the vaccine;

         11. Subject had any malignancy in the past 5 years. If treatment for cancer was
             successfully completed more than 5 years ago and the malignancy is considered to be
             cured, the subject may be enrolled;

         12. Subject had acute febrile infections within 10 days prior to first vaccination;

         13. Subject is pregnant (positive serum pregnancy test at screening), has plans to become
             pregnant during the course of the study or is lactating at the time of enrollment.
             Women of childbearing potential that are unwilling or unable to employ an adequate
             birth control measure for the duration of the study.

         14. Subject has donated blood or blood-derived products (plasma) within 30 days or
             received blood or blood-derived products (plasma) within 90 days prior to first
             vaccination in this study or plans to donate or use blood or blood products during the
             course of the study;

         15. Subject has any condition that, in the opinion of the investigator, may compromise the
             subject's well-being, might interfere with evaluation of study endpoints, or would
             limit the subject's ability to complete the study;

         16. Subject is committed to an institution (by virtue of an order issued either by the
             judicial or the administrative authorities);

         17. Subject is in a dependent relationship with the sponsor, an investigator or other
             study team member, or the study center. Dependent relationships include close
             relatives and household members (i.e. children, partner/spouse, siblings, parents) as
             well as employees of the investigator or study center personnel.