epidemiologyЭпидемиология и ВакцинопрофилактикаEpidemiology and Vaccinal Prevention2073-30462619-0494«Numicom» LLC10.31631/2073-3046-2019-18-3-28-39epidemiology-739Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESБезопасность и иммуногенность полностью жидкой шестивалентной вакцины АбКДС-ИПВ-ГепВ-Hib у здоровых детей 1-го года жизни в Российской ФедерацииSafety and Immunogenicity of Fully Liquid Hexavalent DTaP-IPV-HepB-Hib Vaccine in Healthy Infants in Russian Federationhttps://orcid.org/0000-0002-7902-6427Намазова-БарановаЛ. С.Namazova-BaranovaL. S.

Лейла Сеймуровна Намазова-Баранова - академик РАН, доктор медицинских наук, профессор (педиатрия), профессор (аллергология и иммунология), зав. кафедрой факультетской педиатрии педиатрического факультета РНИМУ им. Н.И. Пирогова, главный научный сотрудник ЦКБ РАН.

117997, Москва, ул. Островитянова, д. 1. +7985 200-4600

Leyla S. Namazova-Baranova - academican of Russian Academy of Science, Dr. Sci. (Med.), professor (pediatrics), professor (allergology and immunology), head of department of faculty pediatrics.

Moscow, +7985 200 46 00

Leyla.s.namazova@gmail.comhttps://orcid.org/0000-0002-2371-2460ХаритС. М.KharitS. M.

Сусанна Михайловна Харит - доктор медицинских наук, профессор, руководитель отдела профилактики инфекционных заболеваний.

197022, Санкт-Петербург, ул. профессора Попова д. 9, +7-812-234-68- 55

Susanna M.Kharit - Dr. Sci. (Med.), professor, head of department of infectious diseases prevention.

197022, St. Petersburg, 9 prof. Popova str., +7-812-23468- 55

Kharit-s@mail.ruhttps://orcid.org/0000-0002-6194-1408ПерминоваО. А.PerminovaO. A.

Ольга Алексеевна Перминова - кандидат медицинских наук, заместитель главного врача по медицинской части.

614066, Пермь, ул. Советской Армии, 10, +7 912-88-205-49

Olga A. Perminova - Cand. Sci. (Med.), deputy head for medical issues.

614066, Perm, 10 Sovetskoy Armii str., +7 912-88-205-49

perminova20062006@yandex.ruhttps://orcid.org/0000-0002-9977-8845РоманенкоВ. В.RomanenkoV. V.

Виктор Васильевич Романенко - доктор медицинских наук, доцент кафедры эпидемиологии, социальной гигиены и организации госсанэпидслужбы.

Екатеринбург, 620075, ул. Малышева 71а-23. +7 912-241-13-79

Viktor V. Romanenko - Dr. Sci. (Med.), assistant professor, department of epidemiology, social hygiene and organization of sanitary-epidemiologic service.

Yekaterinburg, 620075, 71a-23 Malysheva str. +7 912-241-13-79

Romanenko.v47@gmail.comhttps://orcid.org/0000-0001-9998-5409ОсиповаИ. В.OsipovaI. V.

Ирина Владимировна Осипова - доктор медицинских наук, профессор, зав. кафедрой факультетской терапии и профессиональных болезней.

Irina V. Osipova - Dr. Sci. (Med.), professor, head of department of faculty therapeutics and occupational diseases.

Barnaul, 656038, 40 pr-t Lenina. .+7 385 220 12 79

i.v.osipova@gmail.comhttps://orcid.org/0000-0001-9263-5748АсатрянА. Г.AsatryanА. G.

Асмик Георгиевна Асатрян - главный врач и врач-инфекционист.

Гатчина, 188300, пр. 25 Октября, д. 16. +7 813-719-2267

Asmik G. Asatryan - chief physician and ID specialist.

Stomamedservis Ltd., Gatchina, 188300, 16 pr-t 25 Oktyabra, +7 813-719-22-67

office@smeds.ruГольдштейнА. В.GoldsteinA. V.

Александр Валерьевич Гольдштейн - ведущий медицинский эксперт региона Евразия/Турция.

Москва, 125009, ул. Тверская, д. 22. +7495-721-14-00

Alexander Valeryevich Goldstein - leading medical expert of Eurasia/Turkey MCO.

Moscow, 125009, 22 Tverskaya str.,+7495-721-14-00

alexander.goldstein@sanofi.comБ'ЧирС.B'ChirS.

Сихам Бчир - биостатистик Санофи Пастер.

Марси Л'Этуаль, 69280, 1541 авеню Марселя Мерье, 33 4 37 37 5861

Siham Bchir - biostatistician.

69280, 1541 avenue Marcel Merieux, 33 4 37 37 5861

siham.bchir@sanofi.comЛябисО. И.LyabisO. I.

Ольга Игоревна Лябис - глобальный медицинский эксперт.

Лион, 69007, 14 Espace Henry Vale, 33 4 37 37 7464

Olga Igorevna Lyabis - global medical expert

Lyon, 69007, 14 Espace Henry Vale, 33 4 37 37 7464

olga.lyabis@sanofi.comРоссийский национальный исследовательский медицинский университет им. Н.И. ПироговаРоссияPirogov Russian National Research Medical UniversityRussian FederationДетский научно-клинический центр инфекционных болезней ФМБА РФРоссияChildren’s Scientific and Clinical Center for Infectious DiseasesRussian FederationДетская городская клиническая поликлиника №5РоссияChildren’s Outpatient Clinic No. 5Russian FederationУральский государственный медицинский университетРоссияUral State Medical UniversityRussian FederationАлтайский государственный медицинский университетРоссияAltay State Medical UniversityRussian FederationИнститут эпидемиологии и микробиологии им. Пастера Роспотребнадзора РФРоссияPasteur Institute of Epidemiology and MicrobiologyRussian FederationСанофи ПастерРоссияSanofi PasteurRussian Federation2019250620191832839Copyright © Намазова-Баранова Л.С., Харит С.М., Перминова О.А., Романенко В.В., Осипова И.В., Асатрян А.Г., Гольдштейн А.В., Б'Чир С., Лябис О.И., 20192019Намазова-Баранова Л.С., Харит С.М., Перминова О.А., Романенко В.В., Осипова И.В., Асатрян А.Г., Гольдштейн А.В., Б'Чир С., Лябис О.И.Namazova-Baranova L.S., Kharit S.M., Perminova O.A., Romanenko V.V., Osipova I.V., Asatryan А.G., Goldstein A.V., B'Chir S., Lyabis O.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.epidemvac.ru/jour/article/view/739Актуальность

Актуальность. Комбинированные вакцины являются ключевым фактором контроля таких инфекционных заболеваний как дифтерия, столбняк, коклюш, полиомиелит, гепатит В, а также инфекций, вызванных Haemophilus influenzae тип b (Hib). Полностью жидкая шестивалентная АбКДС-ИПВ-ГепВ-Hib вакцина подробно изучена в ряде стран.

Цель исследования - изучить в Российской Федерации безопасность, иммуногенность полностью жидкой шестивалентной вакцины АбКДС-ИПВ-ГепВ-Hib у детей первого года жизни. Материалы и методы. В 6 клинических центрах дети в возрасте 6 мес., получившие моновакцину против гепатита В в первые 24 ч после рождения и в возрасте 1 мес. жизни, а также пятивалентную вакцину (АбКДС-ИПВ//Hib) в возрасте 3 и 4,5 мес. жизни, были привиты шестивалентной вакциной АбКДС-ИПВ-ГепВ-Hib. Безопасность вакцины оценивалась в течение первых 30 мин. (немедленные нежелательные явления - НЯ), 7 дней (ожидаемые местные и общие нежелательные реакции - НР) и 30 дней (не ожидаемые НЯ) после вакцинации. Иммуногенность оценивалась через 1 мес. после вакцинации с использованием валидированных лабораторных методов.

Результаты и обсуждение

Результаты и обсуждение. В течение 30 мин. после вакцинации немедленных НЯ не зарегистрировано. В течение 7 дней после вакцинации у 38,0 и 49,0% участников исследования отмечена ≥ 1 ожидаемая местная и общая НР соответственно. В течение 30 дней после вакцинации у 16,0% отмечено не ожидаемое НЯ. Серьезные НЯ отсутствовали. Анализ иммуногенности показал, что через 1 мес. после вакцинации у 100,0% участников отмечались уровни анти-HBs ≥ 10 мМЕ/мл, анти- дифтерийных и анти- столбнячных антител ≥ 0,01 МЕ/мл, анти-полио-1, 2, 3 - ≥ 1:8. У 98% участников отмечались антитела к полирибозилрибитолфосфату Hib в концентрации ≥ 0,15 мкг/мл. Среднегеометрическая величина концентрации антител против антигенов коклюша - коклюшного токсина и филаментозного гемагглю-тинина - находилась в ожидаемом диапазоне. Выводы. Уровень безопасности и иммуногенности шестивалентной АбКДС-ИПВ-ГепВ-Hib вакцины соответствует всем требованиям, предъявляемым к вакцинам в РФ, препарат может использоваться согласно Национальному календарю профилактических прививок РФ.

Relevance/aims

Relevance/aims: Multivalent vaccines are crucial in the control of diseases including diphtheria (D), tetanus (T), pertussis (P), polio, hepatitis B (HB), and Haemophilus influenzae type b (Hib [PRP~T]). To evaluate the safety and immunogenicity of a fully liquid, hexavalent DTaP-IPV-HB-PRP~Tvaccine in infants in the Russian Federation.

Materials & methods

Materials & methods. Infants (N=100) who had received a standalone HB vaccine within 24 hours after birth and at 1 month of age and a pentavalent (DTaP-IPV/PRP~T) vaccine at 3 and 4.5 months of age were enrolled and received the hexavalent DTaP-IPV-HB-PRP~T vaccine at 6 months of age. Safety was assessed from parental reports and immunogenicity using validated assays.

Results

Results. There were no safety concerns, with 38.0% and 49.0% of participants experiencing ≥ 1 solicited injection site and ≥ 1 solicited systemic reaction within 7 days after vaccination, respectively, and 16.0% reporting an unsolicited adverse event (AE) within 30 days after vaccination. The incidence of each solicited reaction with severity Grade 3 was ≤6.0% and all unsolicited AEs were Grade 1 or 2. Most AEs started ≤ 3 days post-vaccination, were short-lived, and resolved spontaneously. There were no serious AEs. On month post-vaccination 100.0% of participants had antibodies ≥ 10 mIU/ mL for anti-HBs, ≥ 0.01 IU/mL for anti-D and anti-T, ≥8 (1/dil) for anti-polio-1,2, 3, and 97.9% of participants had anti-PRP antibodies ≥ 0.15 gg/ml. For anti-PT and anti-FHA, GMCs were in the expected range.

Conclusion

Conclusion. These results support vaccination with the DTaP-IPV-HB-PRP~T vaccine in the Russian Federation following the recommended national immunization schedule.

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The authors declare that there are no conflicts of interest present.