This study is a Phase 3, Randomized, Placebo-Controlled, Double-Blind Trial to Assess the Safety, Tolerability and Immunogenicity of a new Meningococcal Vaccine When Given in Healthy Subjects Age 11 to 26.
December 20, 2012 (Newswire) - Avail Clinical Research is now enrolling for a Meningitis Vaccine Clinical Trial near Orlando Florida. To get started, visit Avail Clinical Research or call us directly at (386) 310-1334.
Neisseria meningitidis is a leading cause of bacterial meningitis in infants, adolescents, and young adults in developed countries. In particular, Neisseria meningitidis serogroup B (MnB) is responsible for approximately two thirds of the cases of observed meningococcal infections in Europe with a case-fatality rate of 6% to 10% in 2006. MnB disease accounts for approximately one-third of meningococcal cases seen in North America.
A conserved, surface-exposed lipoprotein, LP2086 has been identified as a potential vaccine target. In the meningococcus, LP2086 is a virulence factor that binds human factor H. Neisseria meningitidis serogroup B recombinant lipoprotein 2086 (rLP2086) has been expressed in Escherichia coli and formulated in a bivalent vaccine composed of 1 subfamily A strain and 1 subfamily B strain of rLP2086.
This study will assess the safety, tolerability and immunogenicity of rLP2086 vaccine in healthy subjects aged 11 to 26 years as part of a 0-, 2-, and 6- month schedule, and will form the principle component of the safety database for the Neisseria meningitidis Serogroup B Recombinant Lipoprotein (rLP2086; subfamily A and B; E coli) Vaccine.
To evaluate the safety profile of rLP2086 vaccine, as measured by adverse events (AEs), during the 6-month vaccination period and 6-month postdose 3 follow-up.
To describe the immune response induced by the rLP2086 vaccine as measured by serum bactericidal assays (SBAs) performed with MnB strains expressing LP2086 subfamily A and B proteins, measured 1 month after study vaccinations 2 and 3 in a subset of 255 randomly assigned subjects (170 recipients of 120 Î¼g rLP2086 vaccine and 85 placebo recipients).
This is a randomized, placebo-controlled, double-blind, multicenter trial in which 7,500 subjects will be randomly assigned to 1 of 2 groups in a 2:1 ratio. Group 1 will receive 120 Î¼g rLP2086 vaccine at month 0 (day 1) followed by subsequent vaccinations at months 2 and 6. Group 2 will receive normal saline at month 0 followed by subsequent vaccinations at months 2 and 6.
The study is designed to assess the safety, tolerability and immunogenicity of 120 Î¼g rLP2086 vaccine. The immunogenicity of 120 Î¼g rLP2086 vaccine will be assessed in a subset of 255 randomly assigned subjects (170 in group 1 and 85 in group 2) enrolled at a number of selected sites. Subjects in the immunogenicity subset will maintain their blinded assignment to rLP2086 or saline.
All subjects will have vaccination visits at 0, 2 and 6 months and follow-up visits one month after each vaccination. Follow-up visits for all subjects except the immunogenicity subset will be a telephone contact 1 month (28-42 days) after vaccinations 1 and 2 and a study visit 1 month after vaccination 3. Subjects in the immunogenicity subset will have a telephone contact 1 month after vaccination 1 and study visits 1 month after vaccination 2 and 3 to obtain blood samples for immunogenicity assessments.
All subjects will have a final telephone contact at month 12 (visit 7).
All subjects will be offered HAV vaccination at the final visit (12-month telephone contact). Subjects who accept HAV vaccine will need to return to their study site to receive the vaccination series. HAV vaccine will be administered as per recommended immunization schedules and local clinical practice.
Subjects will participate in the study for up to 14 months. The duration of subject participation is calculated using the last day of each of the visit windows. This includes a telephone contact 6 months after the last study vaccination.
In Phase 1 clinical studies in adults, adolescents, and toddlers, rLP2086 vaccine has been shown to have an acceptable safety profile and has been shown to be immunogenic as measured by SBA. Most subjects who developed reactions experienced only mild or moderate reactogenicity. In an ongoing Phase 2 adolescent study, rLP2086 vaccine has been shown to be well tolerated.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Male or female subjects aged â‰¥11 and