Phase 1/2 Lyme Vaccine Study

This study has been completed.
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01504347
First received: December 22, 2011
Last updated: March 25, 2014
Last verified: March 2014
  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 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 ] [ 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 ]

Enrollment: 1630
Study Start Date: March 2011
Study Completion Date: February 2014
Primary Completion Date: August 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Baxter Innovations GmbH
Investigators
Study Director: Eva Maria Pöllabauer, MD Baxter Innovations GmbH
  More Information

No publications provided by Baxter Healthcare Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 25, 2014
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 July 22, 2014