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Multivalent recombinant OspA Lyme Borreliosis Vaccine

Phase 1

Prophylaxis of Lyme Borreliosis | Monoclonal antibody | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 5, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,630

FDA Designations

No designations recorded

Clinical trial landscape

Multivalent recombinant OspA Lyme Borreliosis Vaccine · 1 trial · 1 indication

Phase 1 1
NCT01504347Phase 1/2 Lyme Vaccine StudyProphylaxis of Lyme Borreliosis
COMPLETED1,630 Analytics
PHASE1COMPLETED
Phase 1/2 Lyme Vaccine Study
Prophylaxis of Lyme Borreliosis
NCT015043471,630
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Primary vaccination in seronegative subjectsEXPERIMENTAL -
Booster vaccination in seronegative subjectsEXPERIMENTAL -
Primary + booster vacc. (seronegative + seropositive subjects)EXPERIMENTAL -

Interventions

NameTypeDescription
Multivalent recombinant OspA Lyme Borreliosis VaccineBIOLOGICALPrimary 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)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes
Study Sites8

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 thro...

Countries:AustriaGermany
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