Clinical trial NCT01504347: Phase 1/2 Lyme Vaccine Study
Official title: Randomized, Double-Blind, Phase 1/2 Clinical Study to Investigate the Safety and Immunogenicity of a Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) in Healthy Subjects Aged 18 to 70 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prophylaxis of Lyme Borreliosis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Baxter Innovations GmbH
First posted: 2012-01-05
Enrollment: 1630
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Main 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
* If female of childbearing potential, 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 seropositive subjects in Section 2 only:

- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

Main Exclusion Criteria:

* Subject has a physician-diagnosed chronic illness related to Lyme borreliosis (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 or active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (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
* 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)
* 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.
* Subject has a history of anaphylaxis or severe allergic reactions
* Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
* Subject is pregnant or lactating at the time of study enrollment

Additional exclusion criterion for subjects in Section 1 and seronegative subjects in Section 2:

- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

Primary outcomes:
measure: Antibody response to the vaccine
timeFrame: 28 days after the third vaccination (= Day 85)
measure: Frequency and severity of injection site and systemic reactions
timeFrame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64)
Secondary outcomes:
measure: Antibody response
timeFrame: 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)
measure: Fold increase in antibody titer compared to baseline
timeFrame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination
measure: Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline
timeFrame: 28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination
measure: Frequency and severity of adverse events
timeFrame: 28 days after each vaccination and during entire study period
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna, Dept. of Clinical Pharmacology
city: Vienna
country: Austria
facility: Zentrum für Reisemedizin (Center for Travel Medicine)
city: Berlin
country: Germany
facility: Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
city: Dresden
country: Germany
facility: GWT-TUD GmbH
city: Freiburg
country: Germany
facility: Hautarztpraxis Cutanis (Dermatologist)
city: Mainz
country: Germany
facility: Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)
city: Rodgau
country: Germany
facility: Innomed Dr. Naudts Klinische Forschung
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Abtlg. Tropenmedizin
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Wressnigg N, Barrett PN, Pollabauer EM, O'Rourke M, Portsmouth D, Schwendinger MG, Crowe BA, Livey I, Dvorak T, Schmitt B, Zeitlinger M, Kollaritsch H, Esen M, Kremsner PG, Jelinek T, Aschoff R, Weisser R, Naudts IF, Aichinger G. A Novel multivalent OspA vaccine against Lyme borreliosis is safe and immunogenic in an adult population previously infected with Borrelia burgdorferi sensu lato. Clin Vaccine Immunol. 2014 Nov;21(11):1490-9. doi: 10.1128/CVI.00406-14. Epub 2014 Sep 3.
citation: Wressnigg N, Pollabauer EM, Aichinger G, Portsmouth D, Low-Baselli A, Fritsch S, Livey I, Crowe BA, Schwendinger M, Bruhl P, Pilz A, Dvorak T, Singer J, Firth C, Luft B, Schmitt B, Zeitlinger M, Muller M, Kollaritsch H, Paulke-Korinek M, Esen M, Kremsner PG, Ehrlich HJ, Barrett PN. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis. 2013 Aug;13(8):680-9. doi: 10.1016/S1473-3099(13)70110-5. Epub 2013 May 10.