Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
Condition: Meningococcal Infection, Group B
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This was a Phase 1, outpatient, open-label, dose-escalating study to evaluate the safety,
      tolerability, and immunogenicity of 4 doses of the Group B Meningococcal HOPS-G 8570 NOMV
      vaccine in healthy subjects. Subjects were screened by medical history; physical exam;
      complete blood count; serum chemistry profile; coagulation studies including prothrombin time
      (PT), partial thromboplastin time (PTT), and fibrinogen; human immunodeficiency virus (HIV)
      test, anti-hepatitis C virus (HCV) antibodies, and hepatitis B surface antigen (HBsAg) test
      results; nasopharyngeal swabs for carriage of meningococci; bactericidal antibody titer to
      meningococci; and urinalysis; and urine pregnancy test results for females. The first 36
      subjects to meet all inclusion criteria and none of the exclusion criteria were assigned to 1
      of 4 dosage groups of 9 subjects each. After screening, there was a 10 to 60 day lead-in time
      (depending on when screening occurred) prior to vaccination during which subjects could not
      take or receive any experimental products. Also prior to vaccination, adverse events were
      recorded to establish a baseline with which to compare adverse events occurring after
      vaccination. Subjects kept a diary for 7 days before the first dose and for 1 day before each
      of the second and third doses. Immediately before each vaccination, vital signs were checked,
      an abbreviated physical examination was performed, each subject's throat was swabbed to
      assess carriage of meningococcal bacteria, and blood was drawn for immunology and safety
      labs. Urine was collected for analysis and females took a urine pregnancy test. The pregnancy
      test results had to be negative in order for a subject to be vaccinated. The vaccine with
      adjuvant was given intramuscularly at 0, 6, and 12 weeks (Study Days 0, 42, and 84) in doses
      of 10 μg, 25 μg, 50 μg, or 75 μg based on protein concentration. Vaccinations were performed
      in a staggered fashion with safety monitoring between groups. The 10-μg dose group was
      divided into 2 subgroups. Subjects in the first subgroup were vaccinated 30 minutes apart to
      observe subjects for the occurrence of acute side effects, and subjects in the second
      subgroup were vaccinated 1 week after the first. The subjects in each group were monitored
      for AE for at least 2 weeks prior to vaccinating the next higher dosage group. Subjects were
      kept in the Clinical Trials Center for 30 minutes after each vaccination for observation, and
      they were asked to keep a diary of symptoms for 7 days after each vaccination. AEs and SAEs
      were recorded at all study visits, and each AE or SAE was assessed for severity and
      relationship to the vaccine by the investigator.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccine; Neisseria meningitidis