Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03010228 | Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis | PHASE1 | COMPLETED | 179 | — | — | Jan 31, 2017 | Jan 16, 2019 | Apr 5, 2023 | 5 | United States, Belgium |
| Arm | Type | Description |
|---|---|---|
| VLA15 12 µg with Alum | ACTIVE_COMPARATOR | VLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (milligram). |
| VLA15 12 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter). |
| VLA15 48 µg with Alum | ACTIVE_COMPARATOR | VLA15 48 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). The amount of Alum per injection is 0.2 mg (milligram). |
| VLA15 48 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). |
| VLA15 90 µg with Alum | ACTIVE_COMPARATOR | VLA15 90 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). The amount of Alum per injection is 0.375 mg (milligram). |
| VLA15 90 µg w/o Alum | ACTIVE_COMPARATOR | VLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). |
| Name | Type | Description |
|---|---|---|
| VLA15 with Alum | BIOLOGICAL | I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses |
| VLA15 without Alum | BIOLOGICAL | I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses |
Inclusion Criteria: * Healthy adults ≥18 to \<40 years of age (for US healthy adults ≥ 19 years to \<40 years) at the time of screening. Health status is assessed by investigator at time of screening based on medical history, physical examination, and laboratory parameters. * Written informed conse...