Completed

NCT Number: NCT01504347

Phase 1/2 Lyme Vaccine Study

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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Key information

Conditions

Prophylaxis of Lyme Borreliosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical University Vienna, Dept. of Clinical Pharmacology, Vienna, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivalent recombinant OspA Lyme Borreliosis Vaccine

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)

Primary outcomes

Antibody response to the vaccine

Time frame: 28 days after the third vaccination (= Day 85)
Frequency and severity of injection site and systemic reactions

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

Secondary outcomes

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)
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
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
Frequency and severity of adverse events

Time frame: 28 days after each vaccination and during entire study period

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

Baxter Innovations GmbH

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2014
First posted: Jan 5, 2012
Registry last updated: May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.