Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04094883 |
Other study ID # |
19-1145 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
October 9, 2019 |
Est. completion date |
September 1, 2020 |
Study information
Verified date |
June 2021 |
Source |
University of North Carolina, Chapel Hill |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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).
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.