Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
Condition: Meningococcal Infection, Group B
MeSH terms: Meningococcal Infections
Intervention: 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine; 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine; 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine; 75 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
Intervention description: 10 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study; 25 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study; 50 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study; 75 μg of Meningococcal 8570 HOPS-G NOMV Vaccine given at 0, 6, and 12 weeks, administered intramuscularly to healthy subjects for duration of study
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccine; Neisseria meningitidis

Summary:

      The purpose of this study is to determine whether a vaccine based on outer membrane vesicles
      (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a
      vaccine. If so, the NOMV in this vaccine will be combined with NOMV from two other
      genetically modified strains as a potentially globally effective vaccine against group B
      meningococcus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy (by physical examination and medical history) military or civilian males or
             females;

          -  Age 18-45 years;

          -  Able to give informed consent, understands risks and benefits of study, assents to use
             of blood samples for future research; understands and is willing to comply with all
             protocol procedures and time commitments;

          -  Females must have a negative urine pregnancy test on vaccination day before each dose
             AND agree to practice an effective birth control method as necessary, for 6 months
             after the first vaccination;

          -  Military service-members who wish to participate must obtain written permission from
             their immediate supervisor, department chief or equivalent, and company commander or
             equivalent.

        Exclusion Criteria:

          -  Current or history of significant organ/system disease;

          -  History of allergy to any vaccine;

          -  History of allergy to aluminum hydroxide;

          -  Presence of significant unexplained laboratory abnormality that in the opinion of the
             PI may potentially confound the analysis of the study results;

          -  HIV seropositive or any other immunosuppressive state;

          -  Positive test for HBsAg or hepatitis C antibody;

          -  Evidence or admission of on-going drug or alcohol abuse/dependence;

          -  Intention to leave the area during the study such that the volunteer would miss 1 or
             more study days;

          -  Prior receipt of any group B meningococcal outer membrane protein (OMP) vaccine or a
             vaccine containing meningococcal OMP;

          -  Has received or plans to receive any live vaccine, Investigational New Drug (IND)
             products or significant immunosuppressive therapy* in the 28 days prior to, or any
             inactivated vaccine within 14 days before initial vaccination or throughout the study,
             or received parenteral immunoglobulin or blood products within 3 months of study
             initiation;

               -  (Intra-articular, topical, or intranasal steroids, steroids applied to the eye,
                  or ≤ 7 days of oral steroids are in general acceptable, depending on the
                  formulation and condition for which they are prescribed. Inclusion of individuals
                  receiving these medications will be made by the PI on a case by case basis)

          -  High levels of baseline bactericidal antibodies against the vaccine strain on
             screening (>1:16) and/or throat carriage of Neisseria meningitidis at time of
             screening;

          -  Positive urine pregnancy test prior to vaccination;

          -  Lactation from first dose through 3 months after last dose;

          -  Any condition in the opinion of the investigator that might interfere with the study
             vaccine.