A prospective multicentre, open label, Phase-I study to evaluate the safety and immunogenicity of Biological E’s Bivalent Typhoid and Paratyphoid A conjugate vaccine administered to 18-55 years-old healthy adults in India.
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.Number and Percentage of participants with solicited administration-site events.
研究概览
简要总结
This is a prospective open label, Phase-I study to assess safety and immunogenicity of Bivalent Typhoid and Paratyphoid A conjugate vaccine administered as a single dose to healthy adults in India.
The target population in this study would be healthy adults of either gender, aged between 18-55 years at the time of vaccination.
A total of 90 adult subjects will be recruited into one of the two treatment arms in 2:1 ratio to receive a single dose of either the Bivalent Typhoid and Paratyphoid A conjugate vaccine (test arm) or Bio E’s monovalent TCV vaccine (comparator or control arm), 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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and non-pregnant female subjects between 18-55 (both inclusive) years of age at the time of vaccination.
- •Subject who after the nature of the study has been explained to them, have given written informed consent according to local regulatory requirements prior to performance of any study specific procedure.
- •Subject’s ability to understand information relevant to participation in the study and abide with the requirements of the subject diary and other study procedures;
- •Individuals in good health as determined by medical history, physical examination and laboratory investigations, based on clinical judgment of the investigator.
- •Participant seronegative for human immunodeficiency virus, hepatitis B, and hepatitis C at screening.
- •Negative urine pregnancy test for female subjects of childbearing potential at screening.
- •7.Female participants of non-childbearing potential.
排除标准
- •Individuals with a previously ascertained or suspected disease caused by Salmonella Typhi or Salmonella Paratyphi A.
- •Individuals with history of household contact with and or intimate exposure to an individual with laboratory confirmed S.
- •Typhi or S.
- •Paratyphi A infection
- •Individuals who have previously received any vaccines against typhoid fever (either oral live attenuated or injectable vaccines);
- •Individuals with body temperature greater than or equal to 100.4°F (38.0°C) within 3 days of intended study vaccine administration.
- •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’s unwillingness or 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;
- •Subject with suspected or known history of an autoimmune disorder or any other known or suspected impairment or 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;
- •Subjects with receipt of immunoglobulins and or any blood derived products, or bone marrow transplantation, in the 90 days preceding vaccination or planned administration during the study period.
- •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;
- •History of allergy, hypersensitivity or allergic reaction to any vaccine-related component; including diphtheria toxoid containing vaccines;
- •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.
- •Subject who had significant acute or chronic infections requiring systemic antibiotics treatment within the past 14 days of study vaccine administration.
结局指标
主要结局
1.Number and Percentage of participants with solicited administration-site events.
时间窗: 1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults. | 2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days. | 3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults. | 4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults. | 5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
2. Number and Percentage of participants with solicited systemic events.
时间窗: 1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults. | 2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days. | 3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults. | 4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults. | 5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
3. Number and Percentage of participants with unsolicited adverse events.
时间窗: 1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults. | 2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days. | 3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults. | 4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults. | 5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
4. Number and Percentage of participants with any serious adverse event (SAE).
时间窗: 1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults. | 2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days. | 3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults. | 4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults. | 5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
5. Number and Percentage of participants with Medically Attended AEs, AEs/SAEs leading to withdrawal from the study.
时间窗: 1. during 60 minutes’ post vaccination observation period and 6 subsequent days in adults. | 2.during 7 days after vaccination, on the day of vaccination and the 6 subsequent days. | 3.during 29 days after vaccination, on the day of vaccination and 28 subsequent days, adults. | 4.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults. | 5.From vaccination until 28 days after vaccination (Day 1 to Day 29), in adults.
次要结局
- Percentage of participants achieving anti-Vi antigen IgG antibody concentrations greater than or equal to 2.0 microgram per ml(before single vaccination (Day 1) and 28 days after single vaccination (Day 29))
- Percentage of participants achieving anti-Vi antigen IgG antibody concentrations greater than or equal to 4.3 microgram per ml(before single vaccination (Day 1) and 28 days after single vaccination (Day 29))
- Percentage of participants achieving at least 4-fold increase in Anti-O:2 IgG antibody concentrations(at 28 days after single vaccination (Day 29) compared to single vaccination baseline)
- Geometric mean concentration (GMC) of anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations(before single vaccination (Day 1), 28 days after single vaccination (Day 29))
- Geometric mean Fold Rise (GMFR) in anti-Vi antigen Immunoglobulin G (IgG) antibody concentrations(after single vaccination, (Day 29) compared to pre-vaccination)
- GMC of Anti-O:2 IgG antibody concentrations(before single vaccination (Day 1), 28 days after single vaccination (Day 29).)
- Geometric mean Fold Rise (GMFR) in Anti-O:2 IgG antibody concentrations(after single vaccination, (Day 29) compared to pre-vaccination)
- Geometric mean titres (GMT) of serum bactericidal activity (SBA) against Salmonella Paratyphi A(at baseline (Day 0) and at day 28 after single vaccination)
研究者
Dr Subhash Thuluva
Biological E.Limited