Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
Condition: Neisseria Gonorrhoeae Infection
MeSH terms: Gonorrhea
Intervention: Meningococcal Group B Vaccine
Intervention description: All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the group B meningitis vaccine (brand name Bexsero™).
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Neisseria gonorrhoeae; Cross-reactive; Immune; Responses; Neisseria meningitidis; Vaccine

Summary:

      The purpose of this study is to test whether the group B meningitis vaccine (brand name
      Bexsero™) induces immune responses against the bacteria that causes gonorrhea.

      Participants: Approximately 15 Individuals who are 18-25 years of age that are not pregnant,
      HIV negative, have no history of congenital immunologic disorder, and are not taking immune
      suppressive medications will be enrolled on this study at a single site, University of North
      Carolina at Chapel Hill (UNC-CH).

      Procedures (methods): Participants will receive two-doses of an FDA-approved vaccine that
      provides protection from N. meningitidis infection according to the recommended dosing
      schedule. The first vaccine dose will be given to participants at the entry visit and the
      second vaccine dose will be given to participants at the week 5 visit. The participants will
      provide samples of blood as well as mucosal surface derived samples (urine and/or swabs) at
      four separate visits (entry, week 5, week 6, and week 7).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to understand and give informed consent

          2. Willingness to undergo all study procedures.

          3. Males or females between the ages of 18 to 25 at screening (inclusive).

          4. Good health, as determined by medical history and targeted physical exam.

          5. Participants agree to abstain from vaccines from study entry to 30 days after receipt
             of the second 4CMenB vaccine.

          6. Female participants of child bearing potential must have a negative urine pregnancy
             test at the screening visit, and prior to receipt of vaccines at study entry and week
             5 visits. Self-reported history is acceptable documentation of hysterectomy, bilateral
             oophorectomy, tubal ligation, or tubal micro-inserts which eliminate child bearing
             potential of participant. If participating in sexual activity that could lead to
             pregnancy, women must agree to use a form of contraceptive until 28 days after
             completion of the vaccine series. At least one of the following methods must be used
             appropriately: Condoms (male) with or without spermicidal agent, Diaphragm or cervical
             cap with spermicide, Intrauterine device (IUD), or Hormone-based contraceptive.
             Self-report of a monogamous male partner who has a vasectomy is also acceptable.

        Exclusion Criteria:

          1. Known allergy/sensitivity or any hypersensitivity to latex or any of the components of
             the study product or its formulation (see section 5.2 for a list of components).

          2. Participants who have received any vaccine directed against N. meningitidis serogroup
             B

          3. Serious illness or injury requiring hospitalization within 21 days prior to study
             entry.

          4. Current or prior history of a medical condition resulting in impaired immunity (such
             as HIV infection, inborn or acquired immunodeficiency syndromes, all cancers including
             leukemia or lymphoma, or the of use antineoplastic drugs or radiation treatment).

          5. Known active infection with HIV, Hepatitis C Virus (HCV ), or Hepatitis B Virus (HBV).
             This information will be obtained verbally from the participant.

          6. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social
             conditions or occupational conditions that in the opinion of the investigator would
             preclude compliance with the study.

          7. Hemophilia or other bleeding diatheses.

          8. Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS)
             are acceptable) within 14 days prior to study entry.

          9. Autoimmune disorders; mild autoimmune disorders, such as eczema, are not exclusionary
             and will be determined by the investigator.

         10. Use of any systemic immunomodulatory treatment, systemic corticosteroids, (inhaled and
             topical corticosteroids acceptable), investigational products, interleukins,
             interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior
             to study entry.

         11. Pregnant women and nursing mothers or women who are planning to become pregnant or
             breastfeed within 28 days after receipt of their second 4CMenB vaccine.

         12. Have received any licensed vaccine within 30 days prior to study vaccination.

         13. Have donated blood or blood products within 30 days before study vaccination, plan to
             donate blood at any time during the study and up to 30 days after the last blood draw.

         14. Any condition in the opinion of the investigator that would interfere with the proper
             conduct of the trial.