Abstract
Introduction. A significant increase in the incidence of pertussis in the world, including among adolescents and adults, the prevalence of mild forms of the disease and asymptomatic carrier of bacteria B. pertussis, and the resulting need for mass revaccination of different age groups determine the demand for new vaccines against B. pertussis. In N.F. Gamaleya Federal Research Center for Epidemiology and Microbiology, a live intranasal pertussis vaccine for the prevention of pertussis (GamLPV) has been developed. The GamLPV vaccine underwent preclinical studies that proved its safety and effectiveness in experiments on small laboratory animals and nonhuman monkeys. Safety of vaccine is shown in clinical studies on healthy volunteers.The aim of the study is to assess the immunogenicity of different doses of the drug GamLPV when first used in healthy volunteers.Materials and methods. The study was conducted as randomized placebo-controlled, blind trial with consistent volunteer inclusion and dose escalation. Study ID in clinicaltrials.gov database: NCT03137927 (A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine). The following parameters of humoral and cellular immune responses were assessed in dynamics: levels of specific IgM, IgG and IgA antibodies in blood serum of volunteers and the number of cytokines interleukin-17, tumor necrosis factor-α, interferon-γ produced after specific induction in vitro of blood mononuclears of vaccinated volunteers. Dynamics of attenuated bacteria persistence in nasopharynx of vaccinated volunteers was evaluated.Results. Intranasal vaccination of volunteers with the drug Gam LPV resulted in the formation of a specific humoral (IgG and IgA) and cellular immune response. The dose-dependent nature of immunoglobulin and cytokine production was shown. Attenuated bacteria persisted for a long time in the nose/oropharynx of vaccinated volunteers.Discussion. Good tolerability of all tested doses of the drug justifies the choice for further investigation of a vaccine dose equal to 4 × 109 CFU. At the next stage, the safety and immunogenicity of two-time vaccination of volunteers will be studied.
Highlights
A significant increase in the incidence of pertussis in the world, including among adolescents and adults, the prevalence of mild forms of the disease and asymptomatic carrier of bacteria B. pertussis, and the resulting need for mass revaccination of different age groups determine the demand for new vaccines against B. pertussis
При введении добровольцам максимальной дозы 3 вакцины на 29-е сутки серопозитивными по IgG-антителам были 6 из 9 вакцинированных (67%) и на 59-е сутки — 8 из 9 вакцинированных (89%)
Среди 9 добровольцев, получивших дозу 2, у 8 (89%) выявлено минимум 5-кратное превышение уровня индуцируемого ИЛ-17 в сравнении с плацебо
Summary
Иммуногенность препарата «Живая вакцина интраназального применения для профилактики коклюша» (ГамЖВК) при однократном применении у здоровых добровольцев. Гамалеи разработана живая коклюшная вакцина интраназального применения для профилактики коклюша (ГамЖВК). Цель исследования — оценка иммуногенности разных доз препарата ГамЖВК при первом применении у здоровых добровольцев. Интраназальная вакцинация добровольцев препаратом ГамЖВК приводит к формированию специфического гуморального (IgG и IgА) и клеточного иммунного ответа. Ключевые слова: живая аттенуированная вакцина, коклюш, Bordetella pertussis, интраназальная вакцинация, гуморальный ответ, клеточный ответ, мукозальный ответ, иммуногенность. Авторы заявляют об отсутствии внешнего финансирования при проведении исследования. Для цитирования: Медкова А.Ю., Лиджиева А.А., Сёмин Е.Г., Синяшина Л.Н., Сюндюкова Р.А., Снегирёва Н.А., Чернышова И.Н., Гаврилова М.В., Бушкова К.К., Колобухина Л.В., Кружкова И.С., Меркулова Л.Н., Русанова М.Г., Дьяков И.Н., Каратаев Г.И.
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