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Meningitis Vaccine Research Study

The purpose of this research study is to study immune responses against Neisseria gonorrhoeae in humans vaccinated with the US Food and Drug Administration (FDA)-approved outer membrane vesicle (OMV)-containing Neisseria meningitidis vaccine known as 4CMenB (trade name Bexsero™), which is given to provide protection from serious infections caused by a related bacteria. This study will test whether receiving this vaccine also leads to immune responses against N. gonorrhoeae. If there are immune responses to N. gonorrhoeae, it remains unknown whether those responses provide any protection from infection.

Age & Gender

  • 18 years ~ 25 years
  • Male, Female

Incentives

  • Compensation
  • Study medication, procedure, or treatment at no cost

Location

What will be asked of you :

The first study visit will involve review of the informed consent, brief physical exam, and review of participant's medical history. At entry and week 5 participants will receive vaccination with the Meningitis B vaccine, Bexsero. These two visits, along with the final two follow-up visits will involve blood draws (4 in total), specimen collection, vital signs and a brief physical exam by a clinical research nurse.

Incentive :

up to $130 for completion of all study visits; plus parking vouchers during the study

In-person visits : up to 5
Phone or online visits : 2
Total length of participation : about 8 weeks (2 months)

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate :

  • In good general health
  • Not planning to get other vaccines while in this study
  • Willing to receive the FDA-approved Meningitis B vaccine, Bexsero
  • Participants born female, not currently pregnant or planning to become pregnant within a month after the second vaccination
  • Not planning on donating blood or other blood products while on this study

Not eligible if :

  • Have already had any group B meningitis vaccine
  • Other vaccine within 30 days of starting the study
  • Serious illness or hospitalization withing 21 days of starting the study
  • Diagnosed with medical conditions or take medicines that interfere with your immune response
  • Allergy or sensitivity to latex

Contact the Team

Location

Contact & Location

Primary Contact

Visit Study Website

Primary Location

Clinical & Translational Research Center (CTRC)

Additional Study Information

Principal Investigator

Alex Duncan
Medicine-Infectious Diseases

Study Type

Clinical or Medical
Interventional

Study Topics

Child and Teen Health
Healthy Volunteer or General Population
Women's Health
Men's Health

IRB Number

19-1145

ClinicalTrials.gov

NCT04094883

Copyright © 2013-2020 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

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