Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
Condition: Neisseria Gonorrhoeae Infection
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      This study is a single center, single arm, interventional pilot study in which participants
      will receive two-doses of the 4CMenB vaccine according to the recommended administration
      schedule and will provide blood, pharyngeal swabs, and urine or self-collected vaginal swabs
      at each of four study visits.

      The study population will include 15 individuals aged 18-25 years with no contraindication to
      vaccination and no known immune compromising medical condition or medication.

      Participants will be seen for informed consent and eligibility screening. Enrolled
      participants will be given 1 dose of 4CMenB at enrollment and a second dose at week 5.
      Participants will be seen at entry, weeks 5, 6, and 7 for blood collection, pharyngeal swabs,
      and provide urine (male participants) or self-collected vaginal swabs collected for secondary
      screening and baseline immunologic testing.

      Screening Evaluations Screening evaluations include: medical history, medication history
      within the past 60 days, vital signs, targeted physical exam, and pregnancy test for female
      participants of child bearing potential). Screening visit must be conducted no greater than
      30 days prior to enrollment visit. The screening evaluation and enrollment visit can all
      occur on the same day. Participants may be re-screened one time.

      Entry Evaluations

      Entry evaluations will be collected PRIOR to phlebotomy, specimen collection, and vaccine
      administration:

      Acute Illness Assessment will be completed before phlebotomy, specimen collection, and
      vaccine administration. Participants who have an acute illness may be rescheduled for their
      phlebotomy, specimen collection, and vaccine within their screening visit window.

      Update medical history and concomitant medications. Conduct a targeted physical exam and
      collect vital signs [heart rate (HR), blood pressure (BP), oral temperature (Temp),
      respiration rate (RR), and weight] prior to phlebotomy to collect up to 60 mL of blood,
      specimen collection, and vaccine administration.

      For females of reproductive potential, negative urine pregnancy testing results must be
      available before phlebotomy, specimen collection, and vaccine administration.

      Samples to be stored for immunologic testing will be batch run at the end of the study:

      pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from
      female participants), serum, and peripheral blood mononuclear cells (PBMC).

      Post-Entry Evaluations

      Week 5 Evaluations:

      Acute Illness Assessment will be completed before phlebotomy, specimen collection, and
      vaccine administration. Participants who have an acute illness or who have taken exclusionary
      anticoagulant medications may be rescheduled for their vaccine within their screening visit
      window.

      Update medical history and concomitant medications before phlebotomy and vaccine
      administration. Conduct a targeted physical exam and collect vital signs (HR, BP, Temp, RR)
      before phlebotomy to collect up to 60 mL of blood, specimen collection, and vaccine
      administration.

      For females of reproductive potential, negative urine pregnancy testing results must be
      available before phlebotomy, specimen collection, and vaccine administration.

      Week 5 laboratory evaluations will be collected PRIOR to vaccine administration:

      Samples to be stored for immunologic testing will be batch run at the end of the study:

      pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from
      female participants), serum, and PBMC.

      Week 6 and Week 7 Evaluations:

      Update medical history and concomitant medications prior to phlebotomy to collect up to 60 mL
      of blood and specimen collection.

      Samples to be stored for immunologic testing will be batch run at the end of the study:

      pharyngeal swabs, urine sample (from male participants), self-collected vaginal swabs (from
      female participants), serum, and PBMC.
    

Intervention name(s): Meningococcal Group B Vaccine
Intervention type(s): Biological
Intervention description(s): All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
Other intervention name(s): Bexsero; 4-component Neisseria meningitidis group B vaccine; 4CMenB
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the group B meningitis vaccine (brand name Bexsero™).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neisseria gonorrhoeae; Cross-reactive; Immune; Responses; Neisseria meningitidis; Vaccine