Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine — 4CMenB  

Neisseria Gonorrhoeae Infection Clinical Trial

Official title: Institute for Global Health and Infectious Diseases (IGHID) 11911 - Cross-reactive N. Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gonorrhea
• Neisseria Gonorrhoeae Infection

• NCT number: NCT04094883
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 4
• Start date: October 9, 2019
• Completion date: September 1, 2020