Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:52 PM
Study NCT ID:
NCT03769194
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
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.
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase. The study was investigated 3 doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy adults aged 18 to 65 years of age. Study participants received 3 immunizations of the vaccine at a monthly interval. The study assessed the immune response as well as the safety profile of the vaccine.
Detailed Description:
This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.
In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15 high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.
Dosing was adjusted by injection volume.
In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.
In both study phases, target was to enroll approx. 10 % or more of subjects that were baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).
In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15 high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.
Dosing was adjusted by injection volume.
In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.
In both study phases, target was to enroll approx. 10 % or more of subjects that were baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: