A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Recombinant meningococcal B + OMV NZ
Intervention description: 2 injections 2 months apart
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neisseria, Meningitis, Group B, Vaccine, At-risk, Adults

Summary:

      The proposed study will evaluate the safety of the rMenB+OMV NZ in an adult population
      potentially at risk for meningococcal disease (e.g. lab workers).

      In the second part of the study additional blood samples of high responding vaccinated
      subjects will be collected for the purpose of generating a control serum panel for the human
      serum bactericidal assay (hSBA) tests.
    

Eligibility criteria:

        Inclusion criteria:

          1. 18 - 65 years of age inclusive who have given written informed consent at the time of
             enrollment;

          2. Able to comprehend and follow all required study procedures;

          3. Who are available for all the visits scheduled in the study (i.e., not planning to
             leave the area before the end of the study period);

          4. In good health as determined by the outcome of medical history, physical examination
             and clinical judgment of the investigator;

          5. Who were or might be routinely exposed to N. meningitidis cultures

        Inclusion criteria for protocol part 2

          1. 18 - 65 years of age inclusive;

          2. At least 50 kg weight;

          3. Blood pressure within the following ranges: Systolic 110-180; Diastolic 60-100;

          4. Regular pulse rate (50-90 beats per minute) - exceptions are acceptable upon
             investigator's judgment;

          5. Hematocrit higher than: 32% for women and 35% for males;

          6. Visit 3 sera suitable as control for standardization of the SBA as confirmed by the
             central laboratory.

        Exclusion criteria:

          1. History of any serogroup B meningococcal vaccine administration

          2. History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component;

          3. Pregnancy or nursing (breastfeeding) mothers;

          4. Females of childbearing age who have not used or do not plan to use acceptable birth
             control measures, for the duration of the study. Oral, injected or implanted hormonal
             contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine
             device, surgical sterilization, transdermal delivery, congenital sterility or sexual
             abstinence are considered acceptable forms of birth control. If sexually active the
             subject must have been using one of the accepted birth control methods at least one
             months prior to study entry;

          5. Known or suspected autoimmune disease or impairment/alteration of the immune system
             resulting from (for example):

          6. Receipt of any chronic immunosuppressive therapy

          7. Receipt of any chronic immunostimulants

          8. Immune deficiency disorder, or known HIV infection

          9. Known bleeding diathesis or any condition that may be associated with a prolonged
             bleeding time.

         10. History or any illness/condition which, in the opinion of the investigator, might
             interfere with the evaluation of the study objectives or pose additional risk to the
             subjects due to participation in the study.

         11. Any significant chronic infection.

         12. Any serious chronic or progressive disease according to judgment of the investigator
             (e.g. neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

        Exclusion criteria for protocol part 2:

          1. Known or suspected autoimmune disease;

          2. Any serious chronic or progressive disease according to judgment of the investigator
             (e.g. neoplasm, diabetes, cardiovascular, renal, hepatic, immunological, metabolic,
             urogenital, hematological, gastrointestinal, central nervous system disease);

          3. Known bleeding diathesis or any condition that may be associated with a prolonged
             bleeding time;

          4. History of fainting or seizure episodes;

          5. Pregnancy

          6. Any significant chronic infection;

          7. Significant acute infections within the previous 2 weeks;

          8. Known or suspected autoimmune disease or impairment/alteration of the immune system
             resulting from (for example):

             Receipt of any chronic immunosuppressive therapy; Receipt of any chronic
             immunostimulants; Immune deficiency disorder, or known HIV infection;

          9. Significant acute illness within the previous 7 days or body temperature 38.0 C within
             the previous 3 days;

         10. Receipt of systemic antibiotics within the previous 3 days (72 hours).