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

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Central Nervous System Infections, Meningitis, toxoid, Meningococcal vaccine, conjugate vaccines Read More

Inclusion Criteria:

• 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.