Lyme Borreliosis, Nervous System Clinical Trial
Official title:
Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Multivalent Recombinant OspA Vaccine Candidate Against Lyme Borreliosis, In Healthy Adults Aged Below 40 Years
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.
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. ;
| Status | Clinical Trial | Phase | |
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| Recruiting |
NCT05641116 -
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
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N/A |