Prophylaxis of Lyme BorreliosisPhase 1/2NCT01504347
Phase 1/2 Lyme Vaccine Study
A Phase 1/2 study testing Multivalent recombinant OspA Lyme Borreliosis Vaccine in people with Prophylaxis of Lyme Borreliosis, run by Baxalta now part of Shire at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis of Lyme Borreliosis
- What is being tested?
- Multivalent recombinant OspA Lyme Borreliosis Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,630 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Mar 2011to 28 Feb 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany6 sites
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
Berlin, 10117
GWT-TUD GmbH
Dresden, 01307
Hautarztpraxis Cutanis (Dermatologist)
Freiburg im Breisgau, 79117
Internistische Gemeinschaftspraxis (Internal Medicine Group Practice)
Mainz, 55116
Innomed Dr. Naudts Klinische Forschung
Rodgau, 63110
Universitätsklinikum Tübingen, Abtlg. Tropenmedizin
Tübingen, 72074
Austria2 sites
Medical University Vienna, Dept. of Clinical Pharmacology
Vienna, 1090
Zentrum für Reisemedizin (Center for Travel Medicine)
Vienna, 1090
About this 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
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
- Being tested
- Multivalent recombinant OspA Lyme Borreliosis Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivalent recombinant OspA Lyme Borreliosis VaccineBiological
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)
Multivalent recombinant OspA Lyme Borreliosis VaccineBiological
Booster vaccination 9-12 months after first vaccination in Section 1 subjects
Multivalent recombinant OspA Lyme Borreliosis VaccineBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| Primary vaccination in seronegative subjects | Experimental | Not described Receives: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine |
| Booster vaccination in seronegative subjects | Experimental | Not described Receives: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine |
| Primary + booster vacc. (seronegative + seropositive subjects) | Experimental | Not described Receives: Biological: Multivalent recombinant OspA Lyme Borreliosis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to the vaccine
Measured: 28 days after the third vaccination (= Day 85)
Frequency and severity of injection site and systemic reactions
Measured: Within 7 days after each vaccination (i.e. Days 8, 36 and 64)
Secondary outcomes (4)
Antibody response
Measured: 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
Measured: 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
Measured: 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
Measured: 28 days after each vaccination and during entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study start1 Mar 2011
- Primary completion13 Sep 2011
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prophylaxis of Lyme BorreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504347
- Sponsor's protocol ID
- 730901
- Other IDs
- 2010-023384-18
- Status last verified
- May 2021
- First submitted
- 22 Dec 2011
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25185574Wressnigg 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.
PubMed 23665341
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01504347
- Acronym / sponsor ID
- 730901
- Conditions
- Prophylaxis of Lyme Borreliosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,630 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Innovations GmbH
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 13 Sep 2011 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multivalent recombinant OspA Lyme Borreliosis VaccinePrimary 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) | Biological | Primary vaccination in seronegative subjects |
| Multivalent recombinant OspA Lyme Borreliosis VaccineBooster vaccination 9-12 months after first vaccination in Section 1 subjects | Biological | Booster vaccination in seronegative subjects |
| Multivalent recombinant OspA Lyme Borreliosis Vaccine3 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) | Biological | Primary + booster vacc. (seronegative + seropositive subjects) |
Primary outcome
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)
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 25185574Wressnigg 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.
- Derived from this study: PubMed 23665341Wressnigg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Multivalent recombinant OspA Lyme Borreliosis Vaccine in people with Prophylaxis of Lyme Borreliosis, run by Baxalta now part of Shire at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response to the vaccine (time frame: 28 days after the third vaccination (= Day 85)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504347, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.