4CMenB
Institute for Global Health and Infectious Diseases (IGHID) 11911 - Cross-reactive N. Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine
Sponsor study identifier
interventional
11
1 country
1
Study Start
October 9, 2019
Actual (reported)Primary Completion
September 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2019
Actual (reported)September 19, 2019
Actual (reported)October 9, 2019
Actual (reported)September 1, 2020
Actual (reported)September 1, 2020
Actual (reported)July 15, 2021
Actual (reported)Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin G (IgG) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgG binding to N. gonorrhoeae strain FA1090 surface antigens Outer-membrane vesicles (OMV) determined by ELISA in serum from entry visit and week 7 visit
pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin M (IgM) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgM binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Change in Anti-N. Gonorrhoeae Outer-membrane Vesicle Specific Immunoglobulin A (IgA ) Concentrations After Immunization
The change in concentrations presented as the difference in geometric mean concentration in human serum of IgA binding to N. gonorrhoeae strain FA1090 surface antigens (Outer-membrane vesicles) determined by ELISA in serum from entry visit and week 7 visit
Participants will receive the 4CMenB (Bexsero) vaccine by an injection in the deltoid region of the upper arm or the higher front area on one side of the thigh at the enrollment visit (Day 0) and at week 5.
All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of North Carolina Health Care
Chapel Hill, North Carolina, 27514, United States
Joseph A Duncan, MD, PhD
UNC-Chapel Hill
11 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2019
First Posted
September 19, 2019
Study Start
October 9, 2019
Actual (reported)Antibacterial Mouthwash for Pharyngeal Gonorrhea Prevention
pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Mean Change in Proportion of Cluster of Differentiation 4 Positive (CD4+) T Cells Expressing at Least Two Different Activation Markers After Immunization
Flow cytometry used to measure the number of CD4+ lymphocytes expressing Interferon-gamma (IFN-g), Tumor Necrosis Factor-alpha (TNF-a), Interleukin-2 (IL-2), and Cluster of Differentiation 107a (CD107a) after in vitro stimulation with N. gonorrhoeae strain FA1090 Outer-membrane vesicles in circulating peripheral blood mononuclear cells (PBMC). The frequency of CD4+ T cells expressing at least two activation markers will be expressed as a proportion of total CD4+ lymphocytes. The change in frequency will be presented as the difference between frequency of cells measured at entry visit and at week 7 visit.
pre-vaccination at entry visit (prior to first vaccination, Day 0) and week 7 visit (2 weeks after second vaccination)
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2020
Actual (reported)Study Completion
September 1, 2020
Actual (reported)Last Updated
July 15, 2021
Results First Posted
July 15, 2021
Record last verified: 2021-06
De-identified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator/researcher who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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