Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76
      MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from
      meningitis.

      This study will vaccinate three groups of people. In the first 2 groups, the study will be
      double-blinded. This means that neither the volunteer or the medical team will know which
      formulation of the vaccine was administered. The third group of volunteers and the medical
      team will know that they are receiving the higher dose of the vaccine.
    

Detailed description: 
      Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that
      can kill children and young adults very quickly. Meningococci are divided into distinct
      sergroups based on their polysaccharide outer capsule, which is the usual target antigen for
      vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States,
      sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer
      protection against serogroup B which currently accounts for 32% of all meningococcal disease
      in the United States.

      This study serves as a proof of concept for our new NOMV Group B single strain monovalent
      vaccine model which is obtained from a genetically modified parent. If successful we plan to
      develop a multivalent Group B vaccine for routine use for military recruits at the beginning
      of basic training, for college students, particularly those who live in dormitories, and for
      use by travelers to countries recognized as having hyperendemic disease.
    

Intervention name(s): 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine; 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.; The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). Two dosage levels were investigated: 25 µg with and without adjuvant and 50 µg of protein without adjuvant. Each dose was given intramuscularly at 0, 6, and 24 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention