Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine

Completed · Phase 4

Conditions studied: Neisseria Gonorrhoeae Infection

In brief

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).

Key facts

Study ID

NCT04094883

Run by

University of North Carolina, Chapel Hill

People needed

11

Starts

2019-10-09

Expected to finish

2020-09-01

Last updated by the study team

2021-07-15

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and give informed consent
• Willingness to undergo all study procedures.
• Males or females between the ages of 18 to 25 at screening (inclusive).
• Good health, as determined by medical history and targeted physical exam.
• Participants agree to abstain from vaccines from study entry to 30 days after receipt of the second 4CMenB vaccine.
• 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.

You may not qualify if…

• 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).
• Participants who have received any vaccine directed against N. meningitidis serogroup B
• Serious illness or injury requiring hospitalization within 21 days prior to study entry.
• 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).
• Known active infection with HIV, Hepatitis C Virus (HCV ), or Hepatitis B Virus (HBV). This information will be obtained verbally from the participant.
• 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.
• Hemophilia or other bleeding diatheses.
• Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) are acceptable) within 14 days prior to study entry.
• Autoimmune disorders; mild autoimmune disorders, such as eczema, are not exclusionary and will be determined by the investigator.
• 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.
• 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.
• Have received any licensed vaccine within 30 days prior to study vaccination.
• 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.
• Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.

Where it is running

• University of North Carolina Health Care — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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