A First in Human Phase I Randomized and Controlled Trial to Test Safety and Immunogenicity of a Multivalent Vaccine Against Neisseria Gonorrhoeae
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Safety: local and systemic AEs (7-days-post)
研究概览
简要总结
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
详细描述
LTB-NG6 is a vaccine including 6 N. gonorrhoeae antigens. During the study, healthy adults will be randomized to receive 1 of 5 different vaccine doses, or a placebo.
Participants will receive a 2-dose schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-50 years (inclusive) at the time of the first injection
- •Good and stable general health, determined by medical history, laboratory findings and physical examination as judged by the Investigator before receiving the first injection.
- •Willingness and ability to comply with the requirements of the protocol (e.g., completion of the diary forms, return for follow-up visits)
- •Signed written informed consent obtained
- •Availability for the trial duration, including all planned follow-up visits and phone calls
- •Negative urine pregnancy test for WOCBP. WOCBP must be willing to use a highly effective method of contraception during the trial
排除标准
- •Health conditions that, in the opinion of the Investigator, may interfere with optimal participation in the trial or place the participant at increased risk of adverse events
- •Acute or active infectious disease (including symptomatic sexually transmitted infections or any other ongoing acute infections), fever (oral temperature ≥38.0°C), or acute illness at the time of enrollment.
- •History of gonorrhea at any time (either self-reported or medically confirmed) or confirmed at screening by a positive nucleic acid amplification test (NAAT) result for Neisseria gonorrhoeae
- •History of prior confirmed N. meningitidis infection
- •Previous vaccination with Bexsero or any meningococcal serogroup B vaccine (including self-report)
- •Any deviation from the normal range in biochemistry or hematology blood tests clinically significant in the opinion of the Investigator, measured at the screening visit
- •Clinical conditions representing contraindication to intramuscular vaccination and blood draws (e.g., coagulation disorder)
- •Known or suspected impairment of immunological function (e.g., documented HIV infection, asplenia/splenectomy, or history of autoimmune disease or lymphoproliferative disorder)
- •Positive test for active HBV infection (positive HBsAG test), any HCV infection (positive HCV antibody test), or any HIV-1/2 infection
- •Planned or actual administration of any licensed vaccine within 14 days prior to enrollment. Note: In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by the public health authorities, the time period described above can be reduced, if necessary, for that vaccine, provided that it is licensed or authorized and that it is used according to the local governmental recommendations, and provided that a written approval from the Sponsor is obtained
- •Body Mass Index (BMI) ≤19 or ≥35
- •History of systemic administration of corticosteroids (PO/IV/IM) within the last month prior to injection or for more than 14 consecutive days within 3 months prior to injection (i.e., prednisone or equivalent ≥20 mg/day). Inhaled and topical steroids are allowed
- •Administration of antineoplastic, immune-modulating, immunosuppressive agents or chemotherapy within 3 months prior to injection
- •Suspected or known hypersensitivity (including allergy) to any of the vaccine components or medical equipment whose use is foreseen in this trial
- •Concurrently participating in another clinical trial or planned participation at any time during the trial period, in which the participant has been or will be exposed to an investigational or a non-investigational interventional vaccine/product (pharmaceutical product)
- •History of any chronic or progressive disease that according to judgment of the Investigator could interfere with the trial outcomes or pose a threat to the participant's health
- •Received an investigational or non-registered product (medicinal drug or vaccine), within 3 months prior to enrollment or planned use during the trial period
- •Administration of immunoglobulin and/or any blood products within the three months prior to enrollment
- •Blood donation equal or greater to 500 mL of blood drawn within 3 months prior to enrollment
- •Participants with an elective surgical intervention, planned during the trial period until one month after second injection
- •Female participants lactating, pregnant, or intending to become pregnant as reported by the participant
研究组 & 干预措施
Placebo
Participants receive 2 administrations of Sodium chloride 0.9%
干预措施: Sodium Chloride 0.9% (Other)
Dose 1
Participants receive 2 Dose 1 administrations of the investigational product
干预措施: LTB-NG6 (Biological)
Dose 2
Participants receive 2 Dose 2 administrations of the investigational product
干预措施: LTB-NG6 (Biological)
Dose 3
Participants receive 2 Dose 3 administrations of the investigational product
干预措施: LTB-NG6 (Biological)
Dose 4
Participants receive 2 Dose 4 administrations of the investigational product
干预措施: LTB-NG6 (Biological)
Dose 5
Participants receive 2 Dose 5 administrations of the investigational product
干预措施: LTB-NG6 (Biological)
结局指标
主要结局
Safety: local and systemic AEs (7-days-post)
时间窗: During 7 days following each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: \- Percentage of participants reporting each solicited local and systemic AE during the seven days after each injection (i.e., day of injection and the six subsequent days).
Safety: any events after each injection
时间窗: During 28 days following each injection
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants reporting any adverse event (AE) following each injection * Percentage of participants reporting each severity level (Grade 1-4) of solicited local, systemic and unsolicited AEs following each injection
Safety: unsolicited AEs, SAEs, MAAEs
时间窗: Through study completion, an average of 18 months
To evaluate the safety and tolerability of vaccination with LTB-NG6 in healthy participants after each injection in vaccinees vs. placebo and by dose: * Percentage of participants with unsolicited AEs. * Percentage of participants with serious adverse events (SAEs) following each injection. * Percentage of participants with medically attended adverse events (MAAEs) following each injection.
Immunogenicity - primary IgGs GMT
时间窗: At 28 days after the second injection
To evaluate the immunogenicity of different doses of LTB-NG6 to identify the preferred dose(s). Serum IgG geometric mean titers (GMTs) against each of the N. gonorrhoeae antigens included in LTB-NG6 summarized by treatment group
次要结局
- Immunogenicity - secondary IgGs(At baseline and 28 days after the second injection)
- Safety: AEs relatedness to injection, vaccine vs. placebo(Through study completion, an average of 18 months)
- Safety: lab abnormalities(At baseline and 7 days after each injection)