An Open label Phase I Study to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine of HBI when administered to Healthy Male Subjects of 18 to 50 years of age.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This
This is An Open label Phase I clinical trial to evaluate the Safety and Immunogenicity of Typhoid Bivalent Conjugate Vaccine of HBI administered in Healthy Male Subjects. 66 subjects will be enrolled in a single centre. The primary objectives are to evaluate the safety of Typhoid Bivalent Conjugate Vaccine of HBI in healthy male subjects of 18 to 50 years of age, proportion of the subjects experiencing local and/or systemic adverse events during follow up period and the occurrence of serious adverse events during follow up period. The Secondary objective is to determine the humoral immune response after administration of Typhoid Bivalent Conjugate Vaccine of HBI in healthy male subjects and the exploratory objectives are to determine the effect of pre-existing anti-tetanus antibodies on the immune responses to typhoid and paratyphoid A. Subjects meeting the inclusion/exclusion criteria will receive single dose (0.5 ml) of the vaccine by intramuscular injection. Subjects will be followed up for 180 days after the vaccination. Blood samples for the antibody titres estimation will be collected from all the enrolled subjects before vaccination on Day 0 (Visit 2), Day 28 (Visit 3), Day 90 (Visit 4) and Day 180 (Visit 5) for measuring anti-Vi IgG and IgA antibodies against S. Typhi and anti-O-polysaccharide IgG antibodies against S. Paratyphi A and functional antibodies using serum bactericidal assay (SBA) against S. Paratyphi A. Also, Anti-tetanus antibodies will be measured on Visit 2(Day 0) and Day 28 (Visit 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Healthy male subjects of 18 to 50 years of age.
- •2.Judged to be in good health on the basis of reported medical history, physical examination, laboratory investigations and clinical judgement of the investigator.
- •3.Plans to remain in the study area for the entire length of the trial.
- •4.Subject is literate and has understood and provided written Informed Consent.
排除标准
- •1.Participation in any other clinical trial in the four weeks preceding the trial vaccination.
- •2.Subjects who have previously received any vaccines against typhoid fever.
- •3.Subjects who have a previously ascertained or suspected disease caused by S.
- •Typhi or S.
- •Paratyphi A.
- •4.Any household member having or exposed to an individual with laboratory confirmed S.
- •5.Planned participation in any other clinical trial during the present trial period.
- •6.Subject who has a known history of allergy to any component of the vaccine.
- •7.Known or suspected primary or acquired disease of the immune system.
- •8.Receiving allergy immunotherapy or immunosuppressive therapy or systemic/oral corticosteroids.
- •9.History of any significant underlying disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, diabetes, hypertension, hematologic or hepatic dysfunction and autoimmune disease.
- •10.Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. asthma, wheezing, shortness of breath).
- •11.Any fever with temperature Greater than or equal to 38.0°C (100.4oF) in last 3 days prior to the study vaccination 12.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
- •14.History of alcoholism or drug abuse.
- •15.Any history of receipt of blood products or immunoglobulins in last 3 months.
- •16.Subjects who have received any live attenuated vaccine in past 30 days and any subunit or inactivated vaccine except for tetanus toxoid vaccine in past 14 days.
- •17.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
结局指标
主要结局
Safety
时间窗: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
1.Solicited/unsolicited local adverse events after a single dose vaccination and during the 28 days follow-up period.
时间窗: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
2.Solicited/unsolicited systemic adverse events after a single dose vaccination and during the 28 days follow-up period.
时间窗: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
3.Occurrence of serious adverse events during the study period.
时间窗: Solicited/unsolicited local and systemic adverse events up to the 28 days follow-up period. | Serious adverse events for entre study period.
次要结局
- 1.Seroconversion rates for anti-Vi IgG and anti-Vi IgA antibody titres against S. Typhi on Days 28, 90 and 180 after vaccination.(2.Seroconversion rates for anti-OPS and SBA antibody titres against S. Paratyphi A on Days 28, 90 and 180 after vaccination.)
研究者
Dr Sai Krishna
Human Biologicals Institute