Phase 1/2 Lyme Vaccine Study

NCT01504347 | Completed Phase 1 DMC

• 2 other identifiers: 7309012010-023384-18
• Study Type: interventional
• Target: 1,630
• Locations: 2 countries
• Sites: 8

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.

Conditions

Prophylaxis of Lyme Borreliosis

Outcome Measures

Primary Outcomes (2)

• Antibody response to the vaccine

  28 days after the third vaccination (= Day 85)

• Frequency and severity of injection site and systemic reactions

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

Secondary Outcomes (4)

• 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)

• 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

• 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

Study Arms (3)

Primary vaccination in seronegative subjects

EXPERIMENTAL

Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine

Booster vaccination in seronegative subjects

EXPERIMENTAL

Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine

Primary + booster vacc. (seronegative + seropositive subjects)

EXPERIMENTAL

Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine

Interventions

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 vaccination in seronegative subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

You may not qualify if:

• 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
• \- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry

Sponsors & Collaborators

• Baxalta now part of Shire: lead
• Baxter Innovations GmbH: collaborator

Study Sites (8)

Medical University Vienna, Dept. of Clinical Pharmacology

Vienna, 1090, Austria

Location

Zentrum für Reisemedizin (Center for Travel Medicine)

Vienna, 1090, Austria

Location

Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)

Berlin, 10117, Germany

Location

GWT-TUD GmbH

Dresden, 01307, Germany

Location

Hautarztpraxis Cutanis (Dermatologist)

Freiburg im Breisgau, 79117, Germany

Location

Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)

Mainz, 55116, Germany

Location

Innomed Dr. Naudts Klinische Forschung

Rodgau, 63110, Germany

Location

Universitätsklinikum Tübingen, Abtlg. Tropenmedizin

Tübingen, 72074, Germany

Location

Related Publications (2)

• Wressnigg N, Barrett PN, Pollabauer EM, O'Rourke M, Portsmouth D, Schwendinger MG, Crowe BA, Livey I, Dvorak T, Schmitt B, Zeitlinger M, Kollaritsch H, Esen M, Kremsner PG, Jelinek T, Aschoff R, Weisser R, Naudts IF, Aichinger G. A Novel multivalent OspA vaccine against Lyme borreliosis is safe and immunogenic in an adult population previously infected with Borrelia burgdorferi sensu lato. Clin Vaccine Immunol. 2014 Nov;21(11):1490-9. doi: 10.1128/CVI.00406-14. Epub 2014 Sep 3.

  PMID: 25185574 DERIVED

• Wressnigg N, Pollabauer EM, Aichinger G, Portsmouth D, Low-Baselli A, Fritsch S, Livey I, Crowe BA, Schwendinger M, Bruhl P, Pilz A, Dvorak T, Singer J, Firth C, Luft B, Schmitt B, Zeitlinger M, Muller M, Kollaritsch H, Paulke-Korinek M, Esen M, Kremsner PG, Ehrlich HJ, Barrett PN. Safety and immunogenicity of a novel multivalent OspA vaccine against Lyme borreliosis in healthy adults: a double-blind, randomised, dose-escalation phase 1/2 trial. Lancet Infect Dis. 2013 Aug;13(8):680-9. doi: 10.1016/S1473-3099(13)70110-5. Epub 2013 May 10.

  PMID: 23665341 DERIVED

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 5, 2012
• Study Start: March 1, 2011
• Primary Completion: September 13, 2011
• Study Completion: February 28, 2014
• Last Updated: May 5, 2021

Record last verified: 2021-05

Locations

AU (2); DE (6)