Development of a Method and a Scheme for the Use of a Live Recombinant Vaccine "GamLPV". Safety and Tolerability of Double Intranasal Vaccination of Healthy Adult Volunteers

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