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
Multivalent recombinant OspA Lyme Borreliosis Vaccine
Multivalent recombinant OspA Lyme Borreliosis Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Prophylaxis of Lyme Borreliosis
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
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
Experimental
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
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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