Study to Assess Gonorrhoeae Immune Responses Induced by a N. Meningitidis Vaccine

NCT04094883 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-1145
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neisseria Gonorrhoeae Infection

Keywords

Neisseria gonorrhoeae; Cross-reactive; Immune; Responses; Neisseria meningitidis; Vaccine

Outcome Measures

Primary Outcomes (4)

• 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

  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)

Study Arms (1)

4CMenB Vaccine

EXPERIMENTAL

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.

Biological: Meningococcal Group B Vaccine

Interventions

Meningococcal Group B Vaccine BIOLOGICAL

All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.

Also known as: Bexsero, 4-component Neisseria meningitidis group B vaccine, 4CMenB

4CMenB Vaccine

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and give informed consent
• Willingness to undergo all study procedures.
• Males or females between the ages of 18 to 25 at screening (inclusive).
• Good health, as determined by medical history and targeted physical exam.
• Participants agree to abstain from vaccines from study entry to 30 days after receipt of the second 4CMenB vaccine.
• Female participants of child bearing potential must have a negative urine pregnancy test at the screening visit, and prior to receipt of vaccines at study entry and week 5 visits. Self-reported history is acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, or tubal micro-inserts which eliminate child bearing potential of participant. If participating in sexual activity that could lead to pregnancy, women must agree to use a form of contraceptive until 28 days after completion of the vaccine series. At least one of the following methods must be used appropriately: Condoms (male) with or without spermicidal agent, Diaphragm or cervical cap with spermicide, Intrauterine device (IUD), or Hormone-based contraceptive. Self-report of a monogamous male partner who has a vasectomy is also acceptable.

You may not qualify if:

• Known allergy/sensitivity or any hypersensitivity to latex or any of the components of the study product or its formulation (see section 5.2 for a list of components).
• Participants who have received any vaccine directed against N. meningitidis serogroup B
• Serious illness or injury requiring hospitalization within 21 days prior to study entry.
• Current or prior history of a medical condition resulting in impaired immunity (such as HIV infection, inborn or acquired immunodeficiency syndromes, all cancers including leukemia or lymphoma, or the of use antineoplastic drugs or radiation treatment).
• Known active infection with HIV, Hepatitis C Virus (HCV ), or Hepatitis B Virus (HBV). This information will be obtained verbally from the participant.
• History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
• Hemophilia or other bleeding diatheses.
• Receipt of anticoagulants (aspirin or nonsteroidal anti-inflammatory drugs (NSAIDS) are acceptable) within 14 days prior to study entry.
• Use of any systemic immunomodulatory treatment, systemic corticosteroids, (inhaled and topical corticosteroids acceptable), investigational products, interleukins, interferons, growth factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
• Pregnant women and nursing mothers or women who are planning to become pregnant or breastfeed within 28 days after receipt of their second 4CMenB vaccine.
• Have received any licensed vaccine within 30 days prior to study vaccination.
• Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the study and up to 30 days after the last blood draw.
• Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina Health Care

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Gonorrhea

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Joseph Duncan, MD, PhD
• Organization: University of North Carolina at Chapel Hill

joseph_duncan@med.unc.edu

919-966-2536

Study Officials

• Joseph A Duncan, MD, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the group B meningitis vaccine (brand name Bexsero™).

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: October 9, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12-24 months after publication
• Access Criteria: Other investigators/researchers who propose to use the individual participant data (IPD) from this study will need to have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Locations

US (1)