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Also known as VLA15
VLA15 with Alum · 1 trial · 1 indication
| 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...
VLA15 is an investigational vaccine being developed for the prevention of Lyme disease, also referred to as Lyme borreliosis, including Lyme borreliosis of the nervous system. It is designed to protect against infection caused by Borrelia bacteria transmitted through tick bites.
VLA15 targets OspA, a protein found on the surface of Borrelia bacteria, the cause of Lyme disease. By targeting OspA, the vaccine aims to generate an immune response that neutralizes the bacteria in the tick before transmission to humans, potentially preventing infection.
VLA15 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the vaccine's safety, efficacy, and immunogenicity for Lyme disease prevention.
VLA15 is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. Pfizer is conducting multiple Phase 3 trials to assess its efficacy, safety, and dosing schedules in diverse populations.
VLA15 is being studied in four clinical trials. NCT05477524 is a completed Phase 3 efficacy trial with 12,546 participants. NCT05634811 is a completed safety study in children. NCT07226882 is an active, not recruiting study on dosing schedules. NCT07500506 is recruiting for a fifth dose safety study.
Yes, VLA15 is a 6-valent OspA-based Lyme disease vaccine. Clinical trial titles describe it as such, indicating it targets six different OspA protein variants to provide broad protection against diverse Borrelia strains causing Lyme disease.