Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

• Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain
• For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions
• Age 18 to 50 years old
• Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (\< two years post-menopause) or non surgically sterile women
• Persons with antibody titer(s) of \<2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA

Exclusion Criteria:

• Age less than 18 years or over 50 years.
• History of Guillain-Barré syndrome (GBS).
• Pregnancy or lactation.
• History of meningococcal meningitis.
• History of invasive (clinical or laboratory diagnosis) meningococcal disease.
• History of meningococcal meningitis vaccination.
• Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study.
• Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents.
• History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination.
• History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator.
• Use of systemic antibiotics within 72 hours prior to study enrollment.
• History of cirrhosis.
• Positive results of testing for HepBsAg, Hepatitis C or HIV-1 or HIV-2 antibodies.
• Positive results of drug screen (amphetamine, THC, cocaine).
• Persons with antibody titer(s) of >2 µg/mL to serogroup (s) A, C, Y, or W 135 as measured by ELISA.
• Unable to understand all of the study requirements.
• Prisoners.
• Participation in a clinical trial in the last three months.
• History of any serious chronic medical or psychiatric illnesses.
• History of significant head trauma, alcohol or substance abuse or other medical illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease) .
• Chronic medication use that, in the opinion of the Investigator, may influence or bias the clinical outcome of the trial.
• Individuals will be excluded from participation in this trial if they are judged by the Principal Investigator as having a significant impairment in their capacity for judgment or reasoning that compromise their ability to make decisions in their best interest.