A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine
Condition: Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.

      On the third day volunteers will be discharged from hospital. 4 visits will be held during
      outpatient observation- on 8, 15, 29 and 60 days after administration - for physical
      examination and laboratory assessment. Beside that it would be suggested to volunteers to
      extend a deadline of participation in the clinical study until 150-th day.

      For each dosing group the consecutive inclusion of volunteers with the intermediate
      evaluation of the safety parameters is stipulated. The group (12 people) is divided into two
      parts. Originally the first part (5 volunteers) is included in the study. Randomization will
      be performed by choosing the envelope with the randomizing number at the day of
      hospitalization. The volunteer will be given either the investigating laboratory specimen or
      placebo. The researcher includes in the study the 2nd part of the group (7 people) after the
      evaluation of the intermediate results of the safety analyses (total blood count, biochemical
      analysis, urinalysis, general examination of a patient). The researcher compiles the
      intermediate report with the analysis of the endurance of the investigating dose of the
      preparation after the evaluation of the intermediate safety results. The criterion of the
      endurance and the dose safety will be at first the absence of serious undesirable phenomena
      and clinically important shifts of the laboratory indices connected with the administration
      of the investigating preparation. The decision about the advisability to continue the study
      and to pass to the 2nd part of volunteers and (or) to escalate the dose will be made by the
      "Independent committee for data monitoring (ICDM) for periodical examination of the clinical
      study, safety data and/or main parameters of the efficacy" as well it must be approved by the
      Local/Independent Ethical Committee of the Research centerе.

      After getting the permission to continue the study the next group will be organized according
      to the analogous scheme: at first the first group of volunteers and then, after receiving the
      safety results in a written form, the 2nd group will be included, the decision to pass from
      the second group to the third will be the same.
    

Intervention name(s): Vaccine GamLPV; Placebo
Intervention type(s): Biological; Other
Intervention description(s): live intranasal vaccine for whooping cough prevention; Placebo
Other intervention name(s): live intranasal Bordetella pertussis vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: bordetella pertussis; vaccine; Immunologic Factors; whooping cough