Whooping Cough Clinical Trial
Official title:
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 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.
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.
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