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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07226882 | A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults | PHASE3 | ACTIVE NOT_RECRUITING | 207 | — | — | Nov 19, 2025 | Jan 27, 2028 | May 6, 2026 | 6 | United States |
| NCT04801420 | Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population | PHASE2 | COMPLETED | 625 | — | — | Mar 8, 2021 | Jul 2, 2025 | May 19, 2026 | 19 | United States |
| NCT03970733 | Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis | PHASE2 | COMPLETED | 246 | — | — | Jul 1, 2019 | Mar 28, 2022 | Apr 21, 2023 | 5 | United States |
| NCT03769194 | Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study. | PHASE2 | COMPLETED | 572 | — | — | Dec 17, 2018 | Oct 2, 2020 | Jan 10, 2023 | 9 | United States, Belgium +1 |
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.
GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 is presented in this outcome measure.
Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) against each Outer Surface Protein A (OspA) serotype ST1 to ST6, determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 208 (Month 7)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 3. Injections will be given as intramuscular shots. |
| Group 2 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 5. Injections will be given as intramuscular shots. |
| Group 3 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 7. Injections will be given as intramuscular shots. |
| Group 4 | EXPERIMENTAL | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 9. Injections will be given as intramuscular shots. |
| Part A+B - Group 1 | EXPERIMENTAL | Part A: VLA15 at Month 0, 2 and 6 Part B: VLA15 at Month 18, 30 and 42 |
| Part A+B - Group 2 | EXPERIMENTAL | Part A: VLA15 at Month 0 and 6, placebo at Month 2 Part B: VLA15 at Month 18, 30 and 42 |
| Part A+B - Group 3 | PLACEBO_COMPARATOR | Part A: Placebo at Month 0, 2 and 6 Part B: Placebo at Month 18, 30 and 42 |
| VLA15 with Alum lower dose | EXPERIMENTAL | Main Study Phase: VLA15 with Alum lower dose - Booster Phase: arm discontinued |
| VLA15 with Alum higher dose | EXPERIMENTAL | Main Study Phase: VLA15 with Alum higher dose - Booster Phase: VLA15 higher dose or placebo |
| Placebo | PLACEBO_COMPARATOR | Main Study Phase: placebo - Booster Phase: arm discontinued |
| VLA15 low dose | ACTIVE_COMPARATOR | VLA15 low dose with Alum. |
| VLA15 medium dose | ACTIVE_COMPARATOR | VLA15 medium dose with Alum. |
| VLA15 high dose | ACTIVE_COMPARATOR | VLA15 high dose with Alum. |
| Name | Type | Description |
|---|---|---|
| VLA15 | BIOLOGICAL | Participants will receive IM injection of 6-valent OspA-based Lyme disease vaccine |
| Placebo | BIOLOGICAL | Saline |
Inclusion Criteria: * Participants who are healthy as determined by medical history and clinical judgment. * Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study. * Able to provide Informed Consent. Exclusion Criteria: * Pregnant...