Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
Condition: Lyme Borreliosis, Nervous System
MeSH terms: Borrelia Infections; Lyme Disease; Lyme Neuroborreliosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy
      adults below 40 years of age.

      180 subjects will be enrolled in 6 treatment groups (different doses; different formulation:
      with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid
      region on Days 0, 28 and 56. Study participants will be followed up until one year after
      first vaccination.

      Booster Extension:

      Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization
      schedule will be included into a Booster Extension 13 months after the first immunization.
    

Detailed description: 
      This is an observer-blind, partially randomized, multi-center dose escalation Phase I study
      which aims to assess the safety, immunogenicity and dose response of VLA15 in healthy adults
      aged below 40 years.

      Overall 180 subjects will be enrolled in 6 treatment groups: VLA15 12µg with and w/o
      (without) Alum, VLA15 48µg with and w/o Alum, VLA15 90µg with and w/o Alum.

      For the first 24 subjects, the study will be open-label and subjects will not be randomized
      but included into a staggered dose escalation scheme for safety precaution. Thereafter, the
      study will be conducted observer-blind in respect to the investigators and site staff
      involved in clinical evaluation of subjects, subjects will be blinded as well. Remaining 156
      subjects will be randomized into the 6 treatment groups. I.M. vaccinations are administered
      on Days 0, 28 and 56 into deltoid region of the non-dominant arm.

      The study will investigate the safety and tolerability as well as immunogenicity of VLA15.
      The primary objective addresses safety and tolerability of the vaccine up to three months
      after enrollment, i.e. 84 days after first vaccination. The study includes 1 screening visit
      and 8 outpatient visits from day 0 through day 365. In addition, safety phone calls will be
      performed.

      Booster Extension:

      Subjects in the 48µg and 90µg dose Groups at the Belgian site, who received a complete
      primary immunization schedule (three vaccinations), will be included into a Booster Extension
      to investigate the safety and immunogenicity of a booster dose of VLA15 administered 13
      months after the first immunization. An extension analysis on safety and immunogenicity will
      be performed after the last subject has completed the last study visit at Month 19.
      Additionally a M14 interim analysis on immunogenicity data will be performed, when all
      subjects completed Month 14.

      For inclusion in the Booster Extension of this study only subjects are eligible, who were
      enrolled in Belgium, completed the primary immunization schedule (three vaccinations) and
      were randomized into 48µg or 90µg dose groups with or without alum. Subjects included in the
      staggered dose escalation phase will not be asked to participate in the Booster Extension for
      operational reasons.
    

Intervention name(s): VLA15 with Alum; VLA15 without Alum
Intervention type(s): Biological; Biological
Intervention description(s): I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses; I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Intervention MeSH terms: Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: VLA15; Lyme Borreliosis; Multivalent Recombinant OspA Vaccine