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Phase 1/2 Lyme Vaccine Study

Primary Purpose

Prophylaxis of Lyme Borreliosis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Multivalent recombinant OspA Lyme Borreliosis Vaccine

About this trial

This is an interventional prevention trial for Prophylaxis of Lyme Borreliosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medical University Vienna, Dept. of Clinical Pharmacology
Zentrum für Reisemedizin (Center for Travel Medicine)
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
GWT-TUD GmbH
Hautarztpraxis Cutanis (Dermatologist)
Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)
Innomed Dr. Naudts Klinische Forschung
Universitätsklinikum Tübingen, Abtlg. Tropenmedizin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Primary vaccination in seronegative subjects

Booster vaccination in seronegative subjects

Primary + booster vacc. (seronegative + seropositive subjects)

Arm Description

Outcomes

Primary Outcome Measures

Antibody response to the vaccine

Frequency and severity of injection site and systemic reactions

Secondary Outcome Measures

Antibody response

Fold increase in antibody titer compared to baseline

Seroconversion rate (at least 4-fold increase of each rOspA type-specific Immunoglobulin G (IgG) titer) as compared to baseline

Frequency and severity of adverse events

Full Information

NCT ID

NCT01504347

First Posted

December 22, 2011

Last Updated

May 3, 2021

Sponsor

Baxalta now part of Shire

Collaborators

Baxter Innovations GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01504347

Brief Title

Phase 1/2 Lyme Vaccine Study

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 1, 2011 (Actual)

Primary Completion Date

September 13, 2011 (Actual)

Study Completion Date

February 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxalta now part of Shire

Collaborators

Baxter Innovations GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prophylaxis of Lyme Borreliosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1630 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary vaccination in seronegative subjects

Arm Type

Experimental

Arm Title

Booster vaccination in seronegative subjects

Arm Type

Experimental

Arm Title

Primary + booster vacc. (seronegative + seropositive subjects)

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Description

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

Intervention Name(s)

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Multivalent recombinant OspA Lyme Borreliosis Vaccine

Intervention Description

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)

Primary Outcome Measure Information:

Title

Antibody response to the vaccine

Time Frame

28 days after the third vaccination (= Day 85)

Title

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 Outcome Measure Information:

Title

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)

Title

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

Title

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

Title

Frequency and severity of adverse events

Time Frame

28 days after each vaccination and during entire study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Medical University Vienna, Dept. of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Zentrum für Reisemedizin (Center for Travel Medicine)

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

GWT-TUD GmbH

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Hautarztpraxis Cutanis (Dermatologist)

City

Freiburg

ZIP/Postal Code

79117

Country

Germany

Facility Name

Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Innomed Dr. Naudts Klinische Forschung

City

Rodgau

ZIP/Postal Code

63110

Country

Germany

Facility Name

Universitätsklinikum Tübingen, Abtlg. Tropenmedizin

City

Tübingen

ZIP/Postal Code

72074

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25185574

Citation

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.

Results Reference

derived

PubMed Identifier

23665341

Citation

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.

Results Reference

derived

Learn more about this trial

Phase 1/2 Lyme Vaccine Study

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