Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Diphtheria; Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Test Vaccine; US Licensed Vaccine
Intervention description: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.; Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Central Nervous System Infections; Meningitis; toxoid; Meningococcal vaccine; conjugate vaccines

Summary:

      The purpose of this study is to evaluate the production of antibodies to a new conjugate
      vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the
      production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135)
      polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate
      the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The
      hypothesis is that the test vaccine is comparable to the licensed active control vaccine.
    

Eligibility criteria:

        Inclusion Criteria (IC):

          -  Participant is willing and able to give informed consent and comply with all aspects
             of the evaluation after the nature of the study is explained.

          -  Male or female, aged 18 to 55 years old

          -  In general good health with no significant chronic or acute conditions that would
             interfere with immune response or expected Adverse Event (AE) evaluation in the
             opinion of the investigator as determined by Medical history and/or History-directed
             physical examination

          -  Abstinence or use of effective contraception by the participants or their partners
             during the trial and continuing for four weeks after vaccination will be required for
             males or female participants of child bearing potential.

          -  Able (in the opinion of the investigator) to comply with all study requirements.

        Exclusion Criteria (EC):

          -  Unwilling or unable to understand study requirements and give written informed consent
             for the study.

          -  Prisoners.

          -  History of Guillain-Barré syndrome (GBS).

          -  Pregnancy (confirmed by positive pregnancy test) or lactation.

          -  Previous diagnosis of laboratory confirmed meningococcal disease.

          -  Previous meningococcal meningitis vaccination in the last five years

          -  Laboratory abnormalities that are considered Grade 2 or higher (based on AE, ranges as
             described in the protocol appendix) that in the opinion of the Investigator would
             raise safety concerns for participation in the study or interfere with evaluation of
             study objectives, or abnormalities >2 times the Upper Limit of Normal range (ULN).

          -  Known or suspected autoimmune or connective tissue disorders, including rheumatoid
             arthritis and congenital or acquired immunodeficiency. Does not include mild to
             moderate seasonal/perennial allergies treated with over the counter antihistamines.

          -  Use of systemic immunosuppressive drugs or therapy within 6 months prior to study
             enrollment, not including topical or inhaled steroids/cytotoxic agents. Includes
             anti-cancer chemotherapy, radiation, and long term systemic corticosteroid therapy.
             History of anaphylactic shock, severe asthma, urticaria, or other allergic or
             hypersensitivity reactions following vaccination or known hypersensitivity to any
             vaccine component.

          -  Received blood, blood products, plasma derivatives or any parenteral immunoglobulin
             preparation in the past 3 months.

          -  Use of systemic antibiotics within 72 hours prior to study enrollment.

          -  History of cirrhosis or hepatitis.

          -  Known bleeding disorder or condition associated with a prolonged bleeding time.

          -  Positive results of testing for hepatitis B surface antigen (HepBsAg), Hepatitis C or
             HIV-1 or HIV-2 antibodies. Known or suspected HIV or Hepatitis B or C infection.

          -  Positive results of drug screen that cannot be explained by use of approved
             prescription medication (amphetamine, tetrahydrocannabinol (THC), cocaine). Current
             (past 30 days) heavy smokers (greater than or equal 1 pack per
             day).tetrahydrocannabinol

          -  Received another investigational product within the last 30 days. Investigational
             product may be a drug, vaccine, medical device or medical procedure.

          -  History of significant head trauma, alcohol or substance abuse or other medical
             illnesses that could cause a neurological deficit (e.g., cerebro-vascular disease).

          -  Medication or alcohol use that, in the opinion of the Investigator, may influence or
             bias the clinical outcome of the trial.

          -  History of any serious chronic medical or psychiatric illnesses or condition which, in
             the opinion of the investigator, might interfere with the evaluation of the study
             objectives.

          -  History of chronic or severe headaches, myalgia, arthralgia, malaise, fatigue or other
             systemic disorder commonly observed as AEs for licensed meningococcal vaccines.

          -  Currently experiencing a cold, flu or other acute illness (subject may be deferred
             until after recovery).