Immunogenicity of a Single Dose of MenB-FHbp or MenACWY-TT/MenB-FHbp in MenB-4C Primed Young Adults
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Percentage of participants who are seroprotected
研究概览
简要总结
The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
The main questions it aims to answer are:
- How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine?
- How strong is the immune response after vaccination, and how many people show a noticeable boost in immune response?
详细描述
Neisseria meningitidis is a human-restricted pathogen that colonizes the nasopharynx and, in rare cases, invades the bloodstream or central nervous system, leading to invasive meningococcal disease (IMD). Clinical manifestations may include meningitis, septicemia, or both. Among the 12 known serogroups, five-A, B, C, W, and Y-account for the majority of global IMD cases. In the United States, serogroups B, C, W, and Y are responsible for approximately 78% of cases across all age groups, with serogroup B being the most prevalent in Europe.
IMD incidence is highest among infants and children under 5 years, adolescents and young adults (particularly ages 16-21), and older adults aged 65 and above.
Vaccination Landscape:
Two monovalent MenB vaccines are currently licensed in the U.S.:
- MenB-4C (Bexsero, GSK)
- MenB-FHbp (Trumenba, Pfizer)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provides written informed consent before any study procedures are performed.
- •Be able to understand and agree to comply with planned study procedures and be available for all study visits.
- •Subject is in good health as determined by vital signs, medical history, targeted physical examination (if indicated), and the judgment of the investigator.
- •Vaccinated with 2-dose Bexsero primary series at least 2.5 years before vaccination. Must confirm vaccination status and dates of administration through GRITS, healthcare provider, or other official documentation
- •Women of childbearing potential must agree to use or have practiced true abstinence2 or use at least one acceptable primary form of contraception from 28 days prior through 28 days after vaccination.
- •Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before vaccination
排除标准
- •Subject has an acute illness with fever (temperature ≥100.4 °F) within 72 hours before vaccine administration.
- •Subject is currently pregnant or breastfeeding an infant/child.
- •Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. (Including acute, subacute, intermittent,t or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. Chronic medical conditions that are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.)
- •Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
- •Received or plans to receive a licensed, live vaccine within 4 weeks before or after the study vaccination.
- •Received or plans to receive a licensed, inactivated vaccine within 2 weeks before through 4 weeks after the study vaccination.
- •Any previous severe hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Received any MenB vaccine within the last 2.5 years before vaccination.
- •Received more than 2 doses of Bexsero or any other MenB vaccine(s) (e.g. Trumenba or Penbraya)
- •Any known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy >20 mg per day for ≥14 days, or those receiving immunosuppressive therapy. Participants with terminal complement deficiency are excluded from participation in this study.
- •Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- •Any neuroinflammatory condition or autoimmune condition requiring immunomodulatory treatment, including, but not limited to, Guillain-Barré syndrome, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
研究组 & 干预措施
Trumenba group
干预措施: Trumenba (Biological)
Penbraya group
干预措施: PENBRAYA (Biological)
结局指标
主要结局
Percentage of participants who are seroprotected
时间窗: Baseline, 28 days post-vaccination
Percentage of participants who are seroprotected, defined as a human serum bactericidal antibody assay (hSBA) titer ≥LLOQ-Lower limit of quantification (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB indicator strains (A22, A56, B24, and B44) with Trumenba or Penbraya. Serum samples from V1 and V2 will be shipped in batches to Pfizer, where hSBA assays will be performed.
次要结局
- Percentage of participants who have composite seroprotection(Baseline, 28 days post-vaccination)
- human Serum bactericidal antibody (hSBA) quantity(Baseline, 28 days post-vaccination)
- Percentage of participants achieving seroresponse(Baseline to 28 days post-vaccination)
研究者
Christina Rostad
Associate Professor
Emory University