Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
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, UNC-CH (University of North Carolina at Chapel Hill).
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 PBMC (peripheral blood mononuclear cells).
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.
Study Design
Conditions
Neisseria Gonorrhoeae Infection
Intervention
Meningococcal Group B Vaccine
Location
University of North Carolina Health Care
Chapel Hill
North Carolina
United States
27514
Status
Recruiting
Source
University of North Carolina, Chapel Hill
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04094883
- ClinicalTrials.gov processed this data on September 23, 2019
Published on BioPortfolio: 2019-09-24T05:27:31-0400
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Medical and Biotech [MESH] Definitions
Meningococcal Vaccines
Vaccines or candidate vaccines used to prevent infection with NEISSERIA MENINGITIDIS.
Ophthalmia Neonatorum
Acute conjunctival inflammation in the newborn, usually caused by maternal gonococcal infection. The causative agent is NEISSERIA GONORRHOEAE. The baby's eyes are contaminated during passage through the birth canal.
Neisseria Meningitidis, Serogroup A
Strains of Neisseria meningitidis responsible for most outbreaks of meningococcal disease in Western Europe and the United States in the first half of the 20th century. They continue to be a major cause of disease in Asia and Africa, and especially localized epidemics in Sub-Sahara Africa.
Meningitis, Meningococcal
A fulminant infection of the meninges and subarachnoid fluid by the bacterium NEISSERIA MENINGITIDIS, producing diffuse inflammation and peri-meningeal venous thromboses. Clinical manifestations include FEVER, nuchal rigidity, SEIZURES, severe HEADACHE, petechial rash, stupor, focal neurologic deficits, HYDROCEPHALUS, and COMA. The organism is usually transmitted via nasopharyngeal secretions and is a leading cause of meningitis in children and young adults. Organisms from Neisseria meningitidis serogroups A, B, C, Y, and W-135 have been reported to cause meningitis. (From Adams et al., Principles of Neurology, 6th ed, pp689-701; Curr Opin Pediatr 1998 Feb;10(1):13-8)
Heptavalent Pneumococcal Conjugate Vaccine
A pneumococcal vaccine which 7 pneumococcal serotypes (6B, 14, 19F, 23F, 18C, 4, 9V), each conjugated individually to the outer membrane protein complex of NEISSERIA MENINGITIDIS.
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