Rotavirus vaccines Review

Yıl 2007, Cilt: 42 Sayı: 11, 36 - 42, 01.05.2007

Zafer Kurugöl

Öz

Rotavirus is a major cause of acute gastroenteritis worldwide and infects almost all children in the first 5 years of life with severe dehydrating gastroenteritis occurring primarily among children 4 to 36 months of age Rotavirus causes an estimated 600 000 deaths and more than 2 million hospitalizations each year A tetravalent rhesus human reassortant rotavirus vaccine Rotashield was licensed in 1998 for routine immunization of infants in the United States However the vaccine was subsequently withdrawn because of a likely association with intestinal intussusception Recently the efficacy and safety of two new rotavirus vaccines the monovalent human rotavirus vaccine HRV Rotarix and the pentavalent human bovine reassortant vaccine PRV RotaTeq was evaluated in large scale trials of more than 130 000 infants The two new rotavirus vaccines have shown good clinical efficacy in preventing rotavirus gastroenteritis especially severe disease These vaccines prevent about 74 percent of all rotavirus cases and about 98 percent of the most severe cases including 96 percent of rotavirus cases requiring hospitalization There was no association between the new rotavirus vaccines and increased risk of intussusception Today these two new rotavirus vaccines have been licensed in more than 90 countries and are used routinely in several countries such as USA Mexico Brazil Venezuela and Panama Vaccine doses should be administered at 2 and 4 months of age 2 doses for HRV or at 2 4 and 6 months 3 doses for PRV The first dose should be administered between 6 and 12 weeks of age; immunization should not be initiated for infants older than 12 weeks of age for PRV or 14 weeks of age for HRV All doses of vaccine should be administered by 24 weeks of age for HRV or 32 weeks of age for PRV Turk Arch Ped 2007; 42 Suppl: 36 42 Key words: Infant reassortant rotavirus vaccines rotavirus

Anahtar Kelimeler

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Rotavirus aşıları Derleme

Öz

Rotavirüs tüm dünyada bebek ve küçük çocuklarda görülen ishallerin özellikle hastane yatışlarına ve bebek ölümlerine neden olan ağır gastroenteritin en önde gelen nedenidir Hemen tüm çocuklar beş yaşına kadar enfekte olurlar ve hastalık özellikle 4 36 ay grubunda dehidratasyon ve asidozla ağır seyrederek ölüme neden olabilir Rotavirüsler her yıl iki milyondan fazla hastane yatışına ve yaklaşık 600 bin ölüme sebep olmaktadır Rotavirüs ishalinin önlenmesinde tek yöntem rotavirüs aşılamasıdır İlk “reassortant” rotavirüs aşısı tetravalan maymun insan “reassortant” rotavirüs aşısı Rotashield ABD’de 1998’de lisans aldı ve aşı şemasına dahil edildi Ancak aşı ile invajinasyon arasında ilişki olduğu gerekçesiyle kısa bir süre içinde kullanımdan kaldırıldı Sonraki yıllarda iki yeni rotavirüs aşısının [monovalan human rotavirüs aşısı HRV Rotarix ve pentavalan human bovine reassortant rotavirüs aşısı PRV RotaTeq ] etkinliği ve güvenirliliği yaklaşık 130 000 bebekte yapılan geniş çalışmalarla değerlendirildi Bu çalışmaların sonuçları her iki yeni rotavirüs aşısının ishale özellikle ciddi ishale karşı etkin ve güvenli bir korunma sağladığını gösterdi Rotavirüs aşılarının rotavirüs olgularını 74 ağır olguları 98 ve hastane yatışlarını 96 azaltması beklenmektedir Rotavirüs aşıları ile invajinasyon riskinin artmadığı gösterilmiştir Günümüzde bu iki yeni rotavirüs aşısı ülkemizinde dahil olduğu 90’dan fazla ülkede lisans alarak kullanıma girmiştir ABD yanında Venezüella Brezilya Panama Meksika ve Avusturya gibi ülkelerde aşı takvimine dahil edilmiştir Aşı ağız yoluyla 2 ve 4 ayda olmak üzere iki dozda HRV için veya 2 4 ve 6 ayda olmak üzere üç dozda PRV için uygulanır İlk doz bebek 6 12 haftalık iken uygulanmalı ve aşılamaya 12 14 haftadan sonra başlanılmamalıdır ve aşılama 24 haftadan HRV için veya 32 haftadan önce HRV için tamamlanmalıdır Türk Ped Arş 2007; 42 Özel Sayı: 36 42 Anahtar kelimeler: Bebek “reassortant” rotavirüs aşıları rotavirüs

Anahtar Kelimeler

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Kaynakça

• Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003; 9: 565-72.
• Glass RI, Compans R, Lang D. Fifth Rotavirus Vaccine Works- hop: Current Issues and Future Developments. Atlanta, Geor- gia 16-17 October 1995. From: Prasad BVV, Burns JW, Mari- etta E, Estes MK, Chiu W. Nature 1990; 343: 476-9.
• Rodriguez WJ, Kim HW, Brandt CD, et al. Longitudinal study of rotavirus infection and gastro-enteritis in families served by a paediatric medical practice: clinical and epidemiologic ob- servations. Pediatr Infect Dis J 1987; 6: 170-6.
• Bresee JS, Parashar UD, Widdowson MA, Gentsch JR, Steele AD, Glass RI. Update on rotavirus vaccines. Pediatr Infect Dis J 2005; 24: 947-52.
• Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhoea in the United States: surveillance and of disease burden. J Infect Dis 1996; 174 (suppl 1): 5-11.
• Devlet İstatistik Enstitüsü, Ölüm İstatistikleri, 1996.
• Ceyhan M, Kanra G, Yeniay I, Ciliv G, Vesikari T. Rotaviruses in infants with diarrhea studied by viral RNA electrophoresis in Ankara, Turkey. Turk J Pediatr 1987; 29: 145-9.
• Karadağ A, Açıkgöz ZC, Avcı Z, et al. Childhood diarrhoea in Ankara, Turkey: epidemiological and clinical features of rotavirus-positive versus rotavirus-negative cases. Scand J Infect Dis 2005; 37: 269-75.
• Altındiş M, Yavru S, Şimşek A, Özkul A, Çeri A, Koç H. Rotavirus infection in children with acute diarrhea as detected by latex agglutination, ELISA and polyacrylamide gel elect- rophoresis. Indian Pediatr 2004; 41: 590-4.
• Kurugöl Z, Geylani S, Karaca Y, et al. Rotavirus gastroenteri- tis among children under five years of age in İzmir, Turkey. T J Ped 2003; 45: 290-4.
• Çataloluk O, Itturiza M, Gray J. Molecular characterization of rotaviruses circulating in the population in Turkey. Epidemiol Infect 2005; 140: 673-8.
• Çiçek C, Karataş T, Altuğlu I, Koturoğlu G, Kurugöl Z, Bilgiç A. Comparison of elisa with shell vial cell culture method for the detection of human rotavirus in fecal specimens detection of human rotavirus. Microbiology (baskıda).
• Velazquez FR, Matson DO, Calva JJ, et al. Rotavirus infecti- ons in infants as protection against subsequent infections. N Eng J Med 1996; 405: 1022-8.
• Ward RL, Bernstein DI. Protection against rotavirus disease after natural rotavirus infection. US Rotavirus Vaccine Efficacy Group. J Infect Dis 1994; 169: 900-4.
• Velazquez FR, Matson DO, Guerrero ML, et al. Serum anti- body as a marker of protection against natural rotavirus infec- tion and disease. J Infect Dis 2000; 182: 1602-9.
• Pérez-Vargas J, Isa P, Lopez S, Arias CF. Rotavirus Vaccine: Early introduction in Latin America. Arch Med Res 2006; 37: 1-10.
• Senturia YD, Peckham CS, Cordery M, et al. Live attenuated oral rotavirus vaccine. Lancet 1987; 2: 1091-2.
• Bernstein DI, Smith VE, Sander DS, et al. Evaluation of WC3 rotavirus vaccine and correlates of protection in healthy in- fants. J Infect Dis 1990; 162: 1055-62.
• Clark HF, Burke CJ, Volkin DB, et al. Safety, immunogenicity and efficacy in healthy infants of G1 and G2 human reassor- tant rotavirus vaccine in a new stabilizer/buffer liquid formula- tion. Pediatr Infect Dis J 2003; 22: 914-20.
• Murphy T, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001; 344: 564-72.
• Vesikari T, Clark HF, Offit PA, et al. Effects of the potency and composition of the multivalent human-bovine (WC3) reassor- tant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 2006; 24: 4821-9.
• Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354: 23-40.
• Bernstein DI, Sack DA, Rothstein E, et al. Efficacy of live, at- tenuated, human rotavirus vaccine 89-12 in infants: a rando- mised placebo-controlled trial. Lancet 1999; 354: 287-90.
• Vesikari T, Karvonen A, Puustinen L, et al. Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pe- diatr Infect Dis J 2004; 23: 937-43.
• Ruiz Palacios G, Perez Schael I, Velazquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354:11-22.
• Perez-Vargas J, Isa P, Lopez S, Arias JF. Rotavirus vaccine: early introduction in Latin America-risks and benefits. Arch Med Res 2006; 37: 1-10.
• RotaTeq [package insert]. Whitehouse Station, NJ: Merck & Co Inc; 2006. Available at: www.merck.com/product/usa/pi_circu- lars/r/rotateq/rotateq_pi.pdf. Accessed August 25, 2006.
• AAP. Prevention of Rotavirus Disease: Guidelines for Use of Rotavirus Vaccine. Committee on Infectious Diseases. Pedi- atrics 2007; 119: 171-82.
• CDC. Press release of the Centers for Disease Control and Prevention, February 21, 2006. http://www.cdc.gov/od/oc/media/pressrel/r060221.htm.
• State of the Art of New Vaccines Research and Development, World Health Organization, Geneva, April 2003.
• Steele D. Alternative upstream rotavirus vaccines. 7th Inter- national Rotavirus Symposium, Lisbon, 12-13 June, 2006.
• Glass RI, Parashar UD, Widdowson MA, Bresee JS, Jiang B, Gentsch JR. The global burden of rotavirus disease: Who needs a rotavirus vaccine and why? 7th International Rotavirus Symposium, Lisbon, 12-13 June, 2006.