NCT01504347

Phase 1/2 Lyme Vaccine Study

Randomized, Double-Blind, Phase 1/2 Clinical Study to Investigate the Safety and Immunogenicity of a Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) in Healthy Subjects Aged 18 to 70 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,630 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study. Section 2: An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.

Conditions

• Prophylaxis of Lyme Borreliosis

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent recombinant OspA Lyme Borreliosis Vaccine	Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts)
BIOLOGICAL	Multivalent recombinant OspA Lyme Borreliosis Vaccine	Booster vaccination 9-12 months after first vaccination in Section 1 subjects
BIOLOGICAL	Multivalent recombinant OspA Lyme Borreliosis Vaccine	3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-09-13
• Completion: 2014-02-28
• First posted: 2012-01-05
• Last updated: 2021-05-05

Locations

8 sites across 2 countries: Austria, Germany