Randomized Double-blind Placebo-controlled Comparative Research of Potency and Safety of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine, Using Two Dosing Schedules and Methods of Application in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- methods of applications
研究概览
简要总结
The study should be leaded as a randomized double-blind placebo-controlled comparative research of potency and safety of a GamLPV, a live intranasal Bordetella pertussis vaccine, using two dosing schedules and methods of application in healthy human volunteers.
The study contains three periods: screening, inpatient hospitalization and follow-up.
详细描述
Subjects are divided into two groups - 25 volunteers in each group. Group 1 will receive vaccine/placebo by drop method. Group 2 will receive vaccine/placebo with nasal actuator. After 60 days both groups will repeatedly receive the same dose of vaccine/placebo by the same methods of application. In each group there are 5 volunteers given placebo.
Monitoring examination of volunteers is carrying out during 60 days after first and second vaccination.
Each group (25 persons) shall be divided into three cohorts (5, 7 and 13 persons). The arm that will receive the drug/ placebo by the dripping method comprises cohorts 1, 3, and 5, and the arm that will receive the drug using the applicator comprises cohorts 2, 4, and 6. Initially, the first and second cohorts (of 5 volunteers each) will be included into the study, respectively.
The main purpose of this study is selection of methods of applications and dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine.
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
- •Male or female aged 18 to 40 (inclusively);
- •Healthy verified diagnosis according to standard clinical, laboratory and instrumental examination methods (no somatic disorder of the gastro-intestinal tract (GIT), liver, kidneys, cardiovascular system (CVS), infectious, hematological diseases, cancers (including if the preliminary standard clinical laboratory tests did not reveal any diseases);
- •BMI froim 18 to 30 kg/m2 (inclusively);
- •Consent to use of reliable birth control methods during the test period and for 3 months thereafter (a condom with spermicide);
- •Signed FactSheet and Informed Consent to Participation in the Study.
- •No specific IgM to the pertussis agent (negative IFA finding according to manufacturer's instruction for the anti-pertussis antibody detection test system);
- •Specific anti-pertussis IgG ≤ 45 EU/ml
- •No B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
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
- •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
- •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
- •Specific anti-pertussis IgG ≥ 45 EU/ml
- •The presence of B.pertussis DNA in nasopharyngeal swabs (based on RT-PCR).
研究组 & 干预措施
Group 2 Nasal actuator
Group 2 will receive vaccine/placebo with nasal actuator.
干预措施: Placebo (Other)
Group 1 Drop method
Group 1 will receive vaccine/placebo by drop method.
干预措施: Vaccine GamLPV (Biological)
Group 1 Drop method
Group 1 will receive vaccine/placebo by drop method.
干预措施: Placebo (Other)
Group 2 Nasal actuator
Group 2 will receive vaccine/placebo with nasal actuator.
干预措施: Vaccine GamLPV (Biological)
结局指标
主要结局
methods of applications
时间窗: the total Time Frame is 140 days after the vaccination
selection of methods of applications of GamLPV, a live intranasal Bordetella pertussis vaccine (drop method or nasal actuator is important for vaccination)
dosing schedules
时间窗: the total Time Frame is 140 days after the vaccination
selection of dosing schedules of GamLPV, a live intranasal Bordetella pertussis vaccine (repeated administration in 60 days)
次要结局
- cell immune responses to B.pertussis(the total Time Frame is 140 days after the vaccination)
- specific antibody response to B.pertussis(the total Time Frame is 140 days after the vaccination)
- dynamics of bacteria generation in nasopharynx of human volunteers(the total Time Frame is 140 days after the vaccination)
- Comparative assessment of immunogenicity(the total Time Frame is 140 days after the vaccination)