Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
Condition: Meningitis, Meningococcal, Serogroup B
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine; 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
Intervention 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). 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
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)
Masking description: The first 2 cohorts were double blind, and the third cohort was not blinded. The investigator preparing the vaccine did not participate in making subsequent study assessments or subject evaluability decisions. After the vaccine was prepared, the subject's identification number was placed onto the drawn syringe. All information, vaccine dose, adjuvant dose (if applicable), and subject identification number, was recorded on the Vaccine Administration Code Form. The form was placed in an envelope. The envelope was sealed and placed in a secured location. The medical personnel who vaccinated the subjects witnessed the dilution and placement of the subject identification number on the syringe. This staff member vaccinated the subject but did not participate in subsequent study visits or the evaluation. The blind was broken after verification that all serology testing was completed.
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy military or civilian males or non-pregnant, non-lactating females

          -  Age 18-45

          -  Give informed consent and understand risk and benefit of study

          -  Understands and willing to comply with all protocol procedures and time commitment

          -  FEMALES only: surgically sterilized or received a negative pregnancy test on day of
             first injection AND agrees to practice adequate birth control, if necessary, for the
             next 7 months after first vaccination.

        Exclusion Criteria:

          -  Currently has or has had a history of significant organ/system disease

          -  History of allergy to any vaccine

          -  Allergy to component of vaccine such as aluminum hydroxide

          -  Presence of significant unexplained laboratory abnormality

          -  HIV sero-positive or any other immunosuppressive state

          -  Positive test for HBsAg, or hepatitis C

          -  Ongoing drug abuse/dependence

          -  Received any live vaccine, experimental products or immunosuppressive therapy in the
             last 28 days or inactivated vaccine in the past 14 days, or received parenteral
             immunoglobulin or blood products within the past 3 months

          -  Intention to leave study area for an extended period of time during the study

          -  Females: positive urine pregnancy test prior to vaccination