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Introduction. The increase in the incidence of whooping cough in children and adults of different age groups justifies the need for their revaccination and the development of new, acceptable for these purposes. This work is devoted to substantiating the design of a clinical trial and describing the results of a comparative study of the safety and tolerability of the drug "GamLPV" with two-fold intranasal administration to healthy adult volunteers using two methods. The choice of the scheme and method of administration of the drug is justified. The serological structure of the population of adults aged 18–40 years living in Moscow and the Moscow region is characterized.Aim. Determination of the safety and tolerability of the drug with a double intranasal administration of the vaccine by drip method and spraying through an actuator.Materials and methods. A randomized placebo-controlled trial included 50 healthy male and female volunteers aged 18 to 40 years who met the inclusion criteria. The volunteers were divided into 2 groups of 25 people: a drip method of administration and spraying through an "actuator". By both methods, the drug was administered twice with an interval of 60 days.Results and discussion. Serological analysis of the population of healthy volunteers at the prescreening stage justified the inclusion in the study of volunteers containing anti-pertussis antibodies in the blood (IgG ≤40 Ed/ml). A comparison of the results of preclinical studies on an experimental model of non-human monkeys and the first phase of a clinical study of GamLPV allowed us to propose two methods of double administration of the drug as a promising vaccination scheme for volunteers. A comparative randomized study shows the safety of using the proposed scheme for vaccination of adult volunteers.Conclusions. Both proposed methods of double administration can be used to plan a multicenter study to research the immunogenicity and protective activity of GamLPV.

Introduction. Due to the growth of laboratory-confirmed cases of pertussis among adolescents and adults, the spread of latent form of disease and the identification of asymptomatic carriage of the pathogen, the need arose to create a new vaccine against B. pertussis. On the basis of N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology, a pertussis vaccine, containing attenuated B. pertussus bacteria, was developed. The article presents data on a clinical trial of the first phase of the pertussis vaccine “GumGVK, live intranasal vaccine for the prevention of pertussis” in healthy volunteers. Based on the results of the study, data shows the safety and tolerability of the first intranasal vaccine using on humans.Aim. To Study the safety and tolerability of the vaccine "GamGVK, live vaccine for intranasal use for the prevention of whooping cough»Materials and methods. Volunteers who expressed a desire to participate in the study were informed about its goals and objectives, conditions and requirements for participants, including the criteria for their inclusion/exclusion from the study. After signing the informed consent, the volunteers were screened for their compliance with the inclusion criteria. Screening studies and safety assessment of the drug were performed on the basis of anamnesis, subjective complaints, assessment of vital signs, ECG, peak flowmetry, results of laboratory tests of urine and blood, enzyme immunoassay of blood serum, analysis of nasopharyngeal aspirates for the presence of pertussis pathogen DNA, results of physical examination.Results and discussion. The study involved 36 "healthy" volunteers aged 18–40 years. The average age of the volunteers was 26.2 ± 5.5 years. Not reliably identified AES associated with the use of GumGVK. None of the used doses of the drug led to the formation of local and General allergic reactions to intranasal administration of GumGVK.Conclusions. The drug GumGVK is safe for nasal use, has good tolerance.