Phase 1/2 Lyme Vaccine Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Prophylaxis of Lyme Borreliosis	Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

Antibody response to the vaccine [ Time Frame: 28 days after the third vaccination (= Day 85) ] [ Designated as safety issue: No ]
Frequency and severity of injection site and systemic reactions [ Time Frame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Seroconversion rate (at least 4-fold increase of each rOspA type-specific 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 ] [ Designated as safety issue: No ]
Frequency and severity of adverse events [ Time Frame: 28 days after each vaccination and during entire study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	650
Study Start Date:	March 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Primary vaccination in seronegative subjects	Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine 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)
Experimental: Booster vaccination in seronegative subjects	Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine Booster vaccination 9-12 months after first vaccination in Section 1 subjects
Experimental: Primary + booster vacc. (seronegative + seropositive subjects)	Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine 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)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504347

Locations

Austria
Medical University Vienna, Dept. of Clinical Pharmacology
Vienna, Austria, 1090
Zentrum für Reisemedizin (Center for Travel Medicine)
Vienna, Austria, 1090
Germany
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
Berlin, Germany, 10117
GWT-TUD GmbH
Dresden, Germany, 01307
Hautarztpraxis Cutanis (Dermatologist)
Freiburg, Germany, 79117
Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)
Mainz, Germany, 55116
Innomed Dr. Naudts Klinische Forschung
Rodgau, Germany, 63110
Universitätsklinikum Tübingen, Abtlg. Tropenmedizin
Tübingen, Germany, 72074

Sponsors and Collaborators

Baxter Healthcare Corporation

Investigators

Study Director:

Baxter BioScience Investigator, MD

Baxter Innovations GmbH

More Information

No publications provided

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT01504347 History of Changes
Other Study ID Numbers:	730901, 2010-023384-18
Study First Received:	December 22, 2011
Last Updated:	June 1, 2012
Health Authority:	Austria: Agency for Health and Food Safety Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:

Borrelia Infections
Lyme Disease
Gram-Negative Bacterial Infections

Bacterial Infections
Spirochaetales Infections
Tick-Borne Diseases

ClinicalTrials.gov processed this record on June 17, 2013