A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine; A Randomized Placebo-controlled Dose-escalating Study of Single-use GamLPV Safety and Tolerability in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- safety and tolerability
研究概览
简要总结
The study contains three periods: screening, inpatient hospitalization and follow-up. And should be leaded as a randomized placebo-controlled study with in chain order enrolled volunteers and dose escalating.
详细描述
After screening, verifying of inclusion/exclusion criteria and signing of informed consent statement volunteers will be directed in a hospital and hospitalized in individual boxes.
Vaccine (GamLPV) or placebo will be administered to groups of volunteers. Each group includes 12 individuals. The study is dose-escalating, so there will be 3 groups.
Group 1: 9 individuals will be vaccinated intranasally with 2,5*108 bacteria (CFU), 3 individuals will get placebo.
Group 2: 9 individuals will be vaccinated intranasally with 109 bacteria cells(CFU), 3 individuals will get placebo.
Group 3: 9 individuals will be vaccinated intranasally with 4*109 bacteria cells(CFU), 3 individuals will get placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females within the age range from 18 to 40 years
- •Health physical condition must be confirmed by routine clinical, laboratory and instrumental methods of diagnosis (absence of gastrointestinal, renal, cardiovascular diseases, hepatic, blood disorders, cancer and infectious diseases)
- •Body-weight index within range from 18 to 30 kg\m2
- •Consent for using of reliable contraception (contraception sheath with spermicidal agents) while study and three months after the end of the study
- •Signed Participant Information Sheet and informed consent
- •Absence of specific antibodies (IgG, IgM, IgA) to Bordetella pertussis (negative ELISA results according to direction for ELISA test-system)
- •Absence of Bordetella pertussis DNA in nasopharyngeal swabs (negative PCR results)
排除标准
- •Whooping cough in past medical history
- •Vaccination against whooping cough over the past decade
- •Any other anti-infective immunization during last year
- •Any medical condition (renal diseases, hepatic disorders, haematological malignancies, malignant neoplasms and other diseases) which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •Vaccine-associated diseases or clinically significant vaccinal reactions in medical history
- •Clinically significant abnormal laboratory values at the discretion of the investigator
- •Use of any medications (in particular herbal medications and dietary supplements) within 30 days after day 0 at the discretion of the investigator
- •Positive results of HIV, hepatitis B or C
- •Use of narcotic drugs and/or a history of drug/alcohol abuse
- •Allergic diseases in medical history (in particular drug reaction and food allergy)
- •The subject has donated blood/plasma or suffered from blood loss of at least 450 ml (1 unit of blood) within 6 weeks prior to screening
- •Current participation in any other clinical trial or participation (and during the whole study) in any clinical trial in the previous 3 months prior to day 0
- •Inability to adhere to the protocol
- •Acute infectious diseases within 4 weeks prior to screening
- •Wheezing on the results of peakflowmetry
- •Significant ECG changes
- •Pregnancy or lactation (for female volunteers)
- •Systolic blood pressure less than 90 mmHg or over than 130 mmHg; diastolic blood pressure less than 60 mmHg or over 90 mmHg
- •Heart rate less than 60 bpm or more than 90 bpm
研究组 & 干预措施
Group 1 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 2,5*10*8 bacteria cells (CFU)
干预措施: Vaccine GamLPV (Biological)
Group 1 placebo
3 individuals will get placebo
干预措施: Placebo (Other)
Group 2 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 10*9 bacteria cells(CFU)
干预措施: Vaccine GamLPV (Biological)
Group 2 placebo
3 individuals will get placebo
干预措施: Placebo (Other)
Group 3 Vaccine GamLPV
9 individuals will be vaccinated intranasally with 4*10*9 bacteria cells(CFU)
干预措施: Vaccine GamLPV (Biological)
Group 3 placebo
3 individuals will get placebo
干预措施: Placebo (Other)
结局指标
主要结局
safety and tolerability
时间窗: the total Time Frame is 150 days after the vaccination
Evaluation of general safety and tolerability of medicinal product "GamLPV, a live intranasal vaccine for whooping cough prevention" in healthy human volunteers compared to placebo, detection the most frequent from possible adverse events of GamLPV
次要结局
- Dose ranging and optimal dose choice(the total Time Frame is 150 days after the vaccination)
- specific antibody response to B.pertussis(the total Time Frame is 150 days after the vaccination)
- dynamics of bacteria generation in nasopharynx of human volunteers(the total Time Frame is 150 days after the vaccination)
- the B- and T-cell immune responses to B.pertussis(the total Time Frame is 150 days after the vaccination)