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Meningitis Vaccine Research Study

University of North Carolina at Chapel Hill


Description

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.


Keywords:

Men's Health, Teens, Women's Health


Category:

Drug or Biologic

Qualifications

 


Age
18 - 25 years


Gender
Any


Study Population

Healthy, non-HIV-infected, male and female volunteers between the ages of 18 and 25.


Investigator

Alex Duncan
Associate Professor
Medicine-Infectious Diseases

For questions, contact:

Brittney Soderman
menBvaccine@med.unc.edu
(919) 962-4643
Visit Website

Recruitment Period End

November 30, 2019

Location

Primary Location
Clinical & Translational Research Center (CTRC)

Study Qualifications

Gender Any

Age Range 18 - 25 years

Participant qualification(s) 18-25 years old, in good general health, will not receive any other vaccines while participating in this study, willing to receive study-related vaccinations, females must agree to use a form of birth control or confirm that they are unable to become pregnant for a valid medical reason (for example: hysterectomy or monogamous male partner with vasectomy).

Not eligible if: Less than 18 or older than 25 years old, already had any group B meningitis vaccine, had any other vaccine within 30 days of starting the study, serious illness or hospitalization withing 21 days of starting the study, pregnant or planning to become pregnant during study, hemophilia or other bleeding condition, active HIV or Hepatitis infection (B or C), have donated blood within 30 days of the study or plan to donate within 30 days of finishing the study, other less common conditions or medications may mean that you cannot participate - the study team will discuss more details with you.

Number of Visits

    » up to 5 In person visit(s)

    Screening, Enrollment/Entry, Week 5, Week 6, Week 7 - Screening and Enrollment Visit may occur on the same day

    » 2 Remote visit(s)

    Phone calls

Participation Period

about 8 weeks (2 months)

Compensation

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

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.