CompletedPhase 4

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

United States11 participantsStarted 2019-10-09

Plain-language 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).

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization

Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)

Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization

Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)

Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization

Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)

Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization

Timeframe: pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)

Trial details

NCT IDNCT04094883

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-01

Results submitted2021-06-24

View on ClinicalTrials.gov More Neisseria Gonorrhoeae Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.