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

Baxalta now part of Shire8 sites in 2 countries1,630 target enrollmentMarch 1, 2011

ConditionsProphylaxis of Lyme Borreliosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prophylaxis of Lyme Borreliosis
Sponsor: Baxalta now part of Shire
Enrollment: 1630
Locations: 8
Primary Endpoint: Frequency and severity of injection site and systemic reactions
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2011

End Date

February 28, 2014

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxalta now part of Shire

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Frequency and severity of injection site and systemic reactions

Time Frame: Within 7 days after each vaccination (i.e. Days 8, 36 and 64)

Antibody response to the vaccine

Time Frame: 28 days after the third vaccination (= Day 85)

Secondary Outcomes

Frequency and severity of adverse events(28 days after each vaccination and during entire study period)
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)
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))