Phase 1 Dose Esc Study of Safety and Immun of 3 Injections, Given at 0, 6 and 24 Wks, of Grp B Meningococcal 44/76 MOS NOMV 5D Vaccine Admin to Healthy Subjs IM With and Without Adjuvant
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Safety: Adverse Event Type Summarized by Dose
研究概览
简要总结
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
详细描述
Meningococcal disease is a contagious bacterial disease caused by Neisseria meningitidis that can kill children and young adults very quickly. Meningococci are divided into distinct sergroups based on their polysaccharide outer capsule, which is the usual target antigen for vaccines. Serogroup A is the main cause of epidemics in Africa and in the United States, sergroups B, C and Y predominate. In the United States, no vaccine is yet available to offer protection against serogroup B which currently accounts for 32% of all meningococcal disease in the United States.
This study serves as a proof of concept for our new NOMV Group B single strain monovalent vaccine model which is obtained from a genetically modified parent. If successful we plan to develop a multivalent Group B vaccine for routine use for military recruits at the beginning of basic training, for college students, particularly those who live in dormitories, and for use by travelers to countries recognized as having hyperendemic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The first 2 cohorts were double blind, and the third cohort was not blinded. The investigator preparing the vaccine did not participate in making subsequent study assessments or subject evaluability decisions. After the vaccine was prepared, the subject's identification number was placed onto the drawn syringe. All information, vaccine dose, adjuvant dose (if applicable), and subject identification number, was recorded on the Vaccine Administration Code Form. The form was placed in an envelope. The envelope was sealed and placed in a secured location. The medical personnel who vaccinated the subjects witnessed the dilution and placement of the subject identification number on the syringe. This staff member vaccinated the subject but did not participate in subsequent study visits or the evaluation. The blind was broken after verification that all serology testing was completed.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy military or civilian males or non-pregnant, non-lactating females
- •Age 18-45
- •Give informed consent and understand risk and benefit of study
- •Understands and willing to comply with all protocol procedures and time commitment
- •FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.
排除标准
- •Currently has or has had a history of significant organ/system disease
- •History of allergy to any vaccine
- •Allergy to component of vaccine such as aluminum hydroxide
- •Presence of significant unexplained laboratory abnormality
- •HIV sero-positive or any other immunosuppressive state
- •Positive test for HBsAg, or hepatitis C
- •Ongoing drug abuse/dependence
- •Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
- •Intention to leave study area for an extended period of time during the study
- •Females: positive urine pregnancy test prior to vaccination
结局指标
主要结局
Safety: Adverse Event Type Summarized by Dose
时间窗: 7 days after each vaccination
Adverse events summarized by type and dose
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
时间窗: 7 day f/u period after each vaccination
Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
次要结局
- Weeks to Serconversion(26 weeks)
- Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion(26 weeks)