A prospective, open label, randomized, controlled Phase-I clinical study to evaluate the safety and immunogenicity of single intramuscular dose of Biological E’s Meningococcal Conjugate Vaccine, administered to 18-45 years-old healthy adults.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 1. Proportion of subjects with solicited local and systemic adverse reactions
研究概览
简要总结
This is a prospective, open label, randomized, comparative, first-in-human, Phase-I study to evaluate the safety, tolerability, reactogenicity and immunogenicity of a single intramuscular dose of adjuvanted and non-adjuvanted formulations of Biological E’s Meningococcal Conjugate Vaccine (MCV) in 18-45-year-old healthy adult subject.
A total of 90 adult subjects will be recruited to one of the three treatment arms in 1:1:1 ratio to receive a single 0.5 mL dose of BE’s Meningococcal Conjugate Vaccine either adjuvanted or non-adjuvanted or a licensed comparator, intramuscularly.
The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and non-pregnant female subjects between 18-45 (both inclusive) years of age at the time of vaccination;
- •Subject, in the opinion of the investigator, has ability to communicate and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential landline or mobile).
- •Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the subject prior to performing any study specific procedure.
- •Subjects considered of stable health as judged by the principal investigator based on personal medical history, protocol specific laboratory parameters and clinical examination findings before entering into the study.
- •Negative urine pregnancy test for female subjects of childbearing potential at screening 6.Female participants of non-childbearing potential.
- •No clinically significant abnormal laboratory parameters at baseline as judged by the investigator.
- •Subjects willing to avoid consumption (ingestion) of chronic herbal medication during the course of the study.
排除标准
- •Individuals with body temperature greater than or equal to 100.4°F within 3 days of intended study vaccine administration;
- •History of any meningococcal vaccine administration and/or disease caused by N.
- •meningitides;
- •Household contact with and or intimate exposure to N.
- •meningitides infections over the last 90 days;
- •Individuals with any progressive unstable or uncontrolled clinical conditions according to judgment of the investigator (e.g., neurological, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease);
- •Subject inability to understand and follow required study procedures, keep appointments, or are planning to relocate during the study period;
- •Individuals with history of any illness or any laboratory abnormality that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; 7.Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids in the previous 30 days;
- •Subject with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time or history of receipt of anti-coagulants in the past 3 weeks;
- •Subjects that have received immunoglobulins and/or any other blood products in the 90 days preceding the vaccination visit
- •History of allergy, hypersensitivity or allergic reaction to any vaccine-related component;
- •Individuals participating in any other clinical trial within 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- •Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study objectives.
结局指标
主要结局
1. Proportion of subjects with solicited local and systemic adverse reactions
时间窗: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days | 2. during the total post vaccination follow up period till day 28. | 3. during the total study period of 28 days’ post-vaccination.
2. Proportion of subjects with unsolicited local and systemic adverse events (AEs)
时间窗: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days | 2. during the total post vaccination follow up period till day 28. | 3. during the total study period of 28 days’ post-vaccination.
3. Serious adverse events (SAEs) and medically attended adverse events (MAAE) if any,
时间窗: 1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days | 2. during the total post vaccination follow up period till day 28. | 3. during the total study period of 28 days’ post-vaccination.
次要结局
- Percentage of subjects achieving a greater than or equal to 4-fold increase in serum bactericidal activity titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodies(At day 28 compared to baseline after a single dose vaccination.)
- Percentage of subjects achieving greater than or equal to 1:8 SBA titres for Meningococcal Polysaccharide A, C, Y, W, and X specific antibodies(at 28 days’ post single dose vaccination)
- Meningococcal Polysaccharide A, C, Y, W, and X specific SBA GMTs(at day 28 post single dose vaccination)
- Geometric Mean Fold Rise (GMFR) in Meningococcal Polysaccharide A, C, Y, W, and X specific GMTs(at day 28 post single dose vaccination from baseline)
研究者
Dr Subhash Thuluva
Biological E.Limited