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Multivalent recombinant OspA Lyme Borreliosis Vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Primary vaccination in seronegative subjects | EXPERIMENTAL | - |
| Booster vaccination in seronegative subjects | EXPERIMENTAL | - |
| Primary + booster vacc. (seronegative + seropositive subjects) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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) |
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...
The multivalent recombinant OspA Lyme Borreliosis vaccine is an investigational vaccine developed by Takeda Pharmaceutical Company Limited for the prophylaxis of Lyme Borreliosis. It is designed to prevent Lyme disease in healthy adults and is being studied in a Phase 1/2 clinical trial.
It is intended for the prophylaxis of Lyme Borreliosis, meaning prevention of Lyme disease in people at risk of infection. The vaccine is administered to healthy volunteers aged 18 years and older. It is not a treatment for existing Lyme disease.
Takeda Pharmaceutical Company Limited, which trades under the ticker TAK, is the developer of the multivalent recombinant OspA Lyme Borreliosis vaccine. The company is responsible for the clinical development program evaluating the vaccine for the prevention of Lyme Borreliosis.
The multivalent recombinant OspA Lyme Borreliosis vaccine is in Phase 1 development. It has been evaluated in a Phase 1/2 study that is now completed. The vaccine remains investigational and has not been approved for use.
The vaccine has been studied in one clinical trial, NCT01504347, titled Phase 1/2 Lyme Vaccine Study. This completed trial enrolled 1,630 healthy volunteers aged 18 years and older in Austria and Germany. It was randomized, double-blind, and controlled.