Phase 1/2 Lyme Vaccine Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-01

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Prophylaxis of Lyme Borreliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Primary vaccination in seronegative subjects

Group Type EXPERIMENTAL

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Type BIOLOGICAL

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)

Booster vaccination in seronegative subjects

Group Type EXPERIMENTAL

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Type BIOLOGICAL

Booster vaccination 9-12 months after first vaccination in Section 1 subjects

Primary + booster vacc. (seronegative + seropositive subjects)

Group Type EXPERIMENTAL

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Type BIOLOGICAL

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)

Interventions

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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)

Intervention Type BIOLOGICAL

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Booster vaccination 9-12 months after first vaccination in Section 1 subjects

Intervention Type 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)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes