None listed
Conditions
Interventions
Product Name: Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 30 µg adjuvanted
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: RECOMBINANT OSPA TYPE 1/2
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Subject is 18 to 70 years old at the time of screening. * Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry; * Subject is generally healthy , as determined by the investigator’s clinical judgment through collection of medical history and the performance of a physical examination; * Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures; * Subject agrees to keep a daily record of symptoms for the duration of the study; * If female of childbearing potential, subject presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study. Additional inclusion criterion for subjects in Cohort 5 only: * Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 649 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: * Subject has a physician-diagnosed chronic illness related to LB or active LB; * Subject has been treated for LB with antibiotics within 3 months of study entry. * Subject had a tick bite within 3 weeks prior to screening or first vaccination; * Subject has a history of or active infection with Babesia microtii or Anaplasma phagocytosum (ehrlichiosis); * Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder ; * Subject has clinically significant abnormal laboratory values at screening; NOTE: a 1.5 fold or greater increase over the upper limit of normal (ULN) for ALT and AST and a value of > 1.5 mg/dl for creatinine is considered clinically significant (see Section 12.4.4.2). Furthermore, any laboratory parameters included in the FDA toxicity grading scale and graded as moderate or higher are to be considered clinically significant. Clinical significance of all other laboratory parameters will be evaluated by the investigator using his/her clinical expertise and judgment. * Subject currently has or has a history of immunodeficiency; *Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); for subjects in Cohort 1 for whom the original exclusion criterion “Subject has a history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study” is applicable, testing will be performed at a later time point upon implementation of Amendment 2 * Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to: systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs; * Subject has a history of anaphylaxis or severe allergic reactions; *Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating; * Subject has a body mass index > 35.0; * Subject has received any blood products or immunoglobulins within 90 days prior to vaccination in this study; * Subject has donated blood or plasma within 30 days prior to vaccination in this study; * Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study; * Subject has functional or surgical asplenia; * Subject has a known or suspected problem with alcohol or drug abuse; * Subject has participated in another clinical study involving an investigational product (IP), biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP, biological product or device during the course of this study; * Subject is pregnant or lactating at the time of study enrollment; * Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -) To evaluate the safety characteristics and immunogenicity of the mv rOspA LB Vaccine using 6 different formulations (3 dose levels with and without adjuvant) and to identify the optimal dose level(s) and/or formulation of the mv rOspA LB Vaccine in seronegative healthy subjects aged 18 to 70 years. -) To evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB vaccine in a larger population of healthy seronegative and seropositive subjects aged 18 to 70 years. ;Secondary Objective: To assess antibody persistence and responses to booster vaccinations with the mv rOspA LB Vaccine. Note: The currently applied for Protocol Amendment 6 pertains to Section 3 of the study: In Section 3, approximately 87 subjects who had been randomized to the 9-12 month booster group to receive the 60 µg adjuvanted formulation of the mv rOspA LB Vaccine will be administered a second booster vaccination at 27 months. Based on recent data from Section 2, the 60 µg adjuvanted dose (instead of the 30 µg adjuvanted dose previously applied for with Protocol Amendment 5) has now been selected for this additional booster vaccination in the extension of the study in Section 3.;Primary end point(s): -) The primary safety endpoint is the frequency and severity of injection site and systemic reactions within 7 days after each vaccination. -) The primary immunogenicity endpoint is the antibody response determined 28 days after the third vaccination to each of the 6 rOspA serotypes contained in the vaccine.;Timepoint(s) of evaluation of this end point: -) The primary safety endpoint is the frequency and severity of injection site and systemic reactions within 7 days after each vaccination. -) The primary immunogenicity endpoint is the antibody response determined 28 days after the third vaccination to each of the 6 rOspA serotypes contained in the vaccine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: The following endpoints will be determined for each of the 6 rOspA serotypes contained in the vaccine: • Antibody response at baseline, 28 days after the first, second and each booster vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination. • Fold increase in antibody titer compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination. • Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination. Safety: • Frequency and severity of adverse events (AEs) observed within 28 days after each vaccination and during the entire study period. ;Timepoint(s) of evaluation of this end point: • Ab response at baseline, 28 d after 1st, 2nd & each booster vaccination, 180 & 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270d after the 2nd booster vaccination; • Fold increase in Ab titer compared to baseline 28 d after each vaccination, 180 and 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270 d after 2nd booster vaccination; • Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 d after each vaccination, 180 & 270 d after the 1st vaccination, 180 d after the 1st booster vaccination & 180 and 270 d after the 2nd booster vaccination. • Frequency and severity of AEs within 28 d after each vaccination ´& during entire study period. | — |
Countries
Austria, Germany
Contacts
Public ContactTA Global Operations Mgr
Baxter Innovations GmbH
Outcome results
None listed