Phase 1/2 Lyme Vaccine Study

Phase 1

Completed

• Conditions: Prophylaxis of Lyme Borreliosis
• Interventions: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine

• Registration Number: NCT01504347
• Lead Sponsor: Baxalta now part of Shire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-01
• Primary Completion: 2011-09-13
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Study Completion: 2014-02-28
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1630

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary + booster vacc. (seronegative + seropositive subjects)	Multivalent recombinant OspA Lyme Borreliosis Vaccine	-
Primary vaccination in seronegative subjects	Multivalent recombinant OspA Lyme Borreliosis Vaccine	-
Booster vaccination in seronegative subjects	Multivalent recombinant OspA Lyme Borreliosis Vaccine	-

Primary Outcome Measures

Name	Time	Method
Frequency and severity of injection site and systemic reactions	Within 7 days after each vaccination (i.e. Days 8, 36 and 64)
Antibody response to the vaccine	28 days after the third vaccination (= Day 85)

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline	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	28 days after each vaccination and during entire study period
Fold increase in antibody titer compared to baseline	28 days after each vaccination, 180 and 270 days after the first vaccination and 180 days after the booster vaccination
Antibody response	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)

Trial Locations

Locations (8)

Zentrum für Reisemedizin (Center for Travel Medicine); 🇦🇹 Vienna, Austria

Hautarztpraxis Cutanis (Dermatologist); 🇩🇪 Freiburg, Germany

Internistische Gemeinschaftspraxis (Internal Medicine Group Practice); 🇩🇪 Mainz, Germany

GWT-TUD GmbH; 🇩🇪 Dresden, Germany

Universitätsklinikum Tübingen, Abtlg. Tropenmedizin; 🇩🇪 Tübingen, Germany

Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT); 🇩🇪 Berlin, Germany

Medical University Vienna, Dept. of Clinical Pharmacology; 🇦🇹 Vienna, Austria

Innomed Dr. Naudts Klinische Forschung; 🇩🇪 Rodgau, Germany