Multicenter Blind Randomized Placebo-Controlled Study of a Live Recombinant Pertussis Vaccine «GamLPV»: Еvaluation of Safety and Tolerability

Relevance. A key feature of the modern pertussis epidemic is the increasing incidence of the disease against the backdrop of years of mass vaccination: since the mid-1950s, with whole-cell pertussis vaccines (WCPV) as part of the DPT vaccine, and since the 1990s, with acellular pertussis vaccines (aPV) as part of the DTaP vaccine in many economically developed countries. The immune response that develops after whooping cough persists for up to 20 years, compared to 4 to 14 years after WCPV vaccination, and up to 6 years after APV vaccination.

Aim. Assessment of the safety of the live recombinant pertussis vaccine «GamLPV» in a multicenter, blind, randomized, placebo-controlled study with double intranasal administration to adult volunteers.

Materials and methods. The study involved 260 adult volunteers aged 18 to 65 years: 210 people in the study «GamLPV» group and 50 people in the «Placebo» group. The vaccine «GamLPV» was administered in a dose of 4.5 x 109 CFU intranasally twice with an interval in 60 ± 5 days, as well as the comparison drug (Placebo). Safety and tolerability were assessed based on data on the frequency of registration, nature and severity of adverse events (AEs) with a double intranasal drug administration of the vaccine.

Results and discussion. During the study, no serious and severe AEs were registered. The analysis of the registered AEs did not confirm a reliable dependence on the administration of the GamLPV and, when compared with placebo, did not reveal statistically significant differences. We show that there was no statistically significant difference in safety parameters between the compared groups of volunteers who administered the GamLPV or placebo. The data from laboratory and instrumental examinations did not reveal significant deviations from the norm and the difference between the «GamLPV» and «Placebo» groups.

Conclusions The results of the phase III of clinical trial vaccine in adult volunteers indicate good tolerability and a high safety profile of the GamLPV vaccine. Based on the conducted research, permission was obtained from the Ministry of Health of the Russian Federation for a new clinical trial of the GamLPV with the participation of volunteers aged 6 and 14 years.

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