Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study. Section 2: An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,630
Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts)
Booster vaccination 9-12 months after first vaccination in Section 1 subjects
3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)
Medical University Vienna, Dept. of Clinical Pharmacology
Vienna, Austria
Zentrum für Reisemedizin (Center for Travel Medicine)
Vienna, Austria
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
Berlin, Germany
GWT-TUD GmbH
Dresden, Germany
Antibody response to the vaccine
Time frame: 28 days after the third vaccination (= Day 85)
Frequency and severity of injection site and systemic reactions
Time frame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64)
Antibody response
Time frame: At baseline, 28 days after each vaccination (i.e. Days 29, 57 and 85), 180 and 270 days after the first vaccination (Day 181, Day 271) and 180 days after the booster vaccination (Day 361 or Day 451 - 546)
Fold increase in antibody titer compared to baseline
Time frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination
Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline
Time frame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination
Frequency and severity of adverse events
Time frame: 28 days after each vaccination and during entire study period
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Hautarztpraxis Cutanis (Dermatologist)
Freiburg im Breisgau, Germany
Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)
Mainz, Germany
Innomed Dr. Naudts Klinische Forschung
Rodgau, Germany
Universitätsklinikum Tübingen, Abtlg. Tropenmedizin
Tübingen, Germany