Oncology
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IXIARO(R) - First Licensed European Vaccine For The Prevention Of Japanese Encephalitis - Now Available In The UK
The first licensed vaccine in Europe to protect British travellers against a potentially fatal mosquito disease is being launched today. The new vaccine for the prevention of Japanese Encephalitis (JE) will be marketed in the UK as IXIARO by Novartis Vaccines. JE, a mosquito-borne infection, is a devastating disease that results in 10,000-15,000 deaths annually and is a potential threat for travellers to Asia. [1,2] Until now there has not been a licensed JE vaccine in Europe although imported vaccines have been available on a named patient basis. The risk of contracting JE from a short urban visit to Asia is generally given as "extremely low" but there have been cases amongst short-stay holiday-makers. [3] The risks for long stays in rural areas during transmission season are higher. [4] Dr Jane Zuckerman, Medical Director of the Royal Free Travel Health Centre at the Royal Free Hospital, London, welcomed the availability of the new vaccine. "In Asian countries Japanese Encephalitis is a major health concern and the epidemiology of the virus appears to be spreading, as it can now be found in parts of Northern Australia. "Generally the risk for European holidaymakers contracting Japanese Encephalitis as a result of travelling to South East Asia is extremely low but there have been cases where people have become ill after holidaying for two weeks in places like Bali. If people are staying or working in rural areas, for instance on gap year or volunteer projects, then the risk of exposure and infection become higher." Dr Zuckerman added: "People should seek medical advice about whether to have the vaccine depending on their own travel circumstances. Until now there has been no licensed Japanese Encephalitis vaccine in Europe, so this new weapon in the vaccine armoury against travel-related disease is very welcome." Dr Richard Dawood, Medical Director of Fleet Street Travel Clinic, London, said "I have come across at least two cases of Japanese encephalitis in young British travellers over the years, both of whom were very severely affected; I am therefore delighted that a modern, generally well tolerated and effective vaccine has now been licensed in Europe." Dr Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, said: "Asia is a very popular travel destination for Europeans. Since JE is spread by mosquitoes, the threat to travellers is unpredictable. Vaccination is the most effective preventive measure against the disease and this vaccine will help travellers from Europe to Asia". IXIARO was developed by Intercell AG. Novartis and Intercell have a strategic alliance that provides Novartis with the commercialisation rights to the vaccine. The Intercell factory which makes IXIARO is located in Livingston, West Lothian. There are in excess of three million Britons a year who travel to the countries where JE is prevalent, according to figures from the World Tourism Organisation. These countries include India, parts of China, Thailand, Indonesia, Cambodia and Vietnam. [5] The risk of acquiring JE on a short holiday visit to urban areas is relatively low, but people on longer stay backpacking trips or engaged in volunteer work in rural areas are judged at higher risk.[3] Symptomatic JE has been estimated to occur in 1 in 300 patients who are infected.[3] Of those that develop full blown Japanese Encephalitis one in three die and half of those who survive will have long-term consequences including brain damage. [2] Guidelines on the use of JE vaccination are available to UK doctors from the National Travel Health Network and Centre (NaTHNaC) together with the Health Protection Agency. [3] These state that vaccination should be given for those intending to stay for long periods in rural endemic regions during the main transmission season, or whose planned activities will increase their risk. [3] IXIARO received its European licence on 2 April 2009. On December 18th 2008, the Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a marketing authorisation to IXIARO. The European Commission has granted marketing authorisation for the 27 countries of the European Union, as well as Norway and Iceland. IXIARO received FDA approval in the United States on 30 March 2009 and was granted Marketing Authorisation in Australia in January 2009. Further paediatric studies with the vaccine are planned. IXIARO Pivotal Study Details A total of 5,102 subjects have participated in eight IXIARO clinical trials. A randomised, multicentre, observer-blinded Phase III study was conducted to evaluate the immunogenicity of two doses of the vaccine compared to three doses of the currently licensed vaccine (in the US) in healthy adults, called JE-Vax®. The primary objective of the study was to demonstrate non-inferiority of IXIARO to JE-Vax in terms of immunogenicity at day 56. Secondary objectives included the safety and local tolerability of both vaccines. IXIARO was found to be highly immunogenic, resulting in protective antibody titres in 99% of subjects following two doses {6]. The immune response following vaccination with the new vaccine was sustained at six months, with 95% of the 181 subjects maintaining protective antibody titres. Eighty-three percent (83%) of subjects still maintained protective antibody levels after one year. [7]. In addition, a multicentre, randomised, double-blind Phase III study was conducted in 2675 healthy adults to assess the safety and tolerability of the vaccine compared with placebo injections. IXIARO was found to be generally well tolerated and no allergic reactions were observed. [8, 9] About IXIARO Vaccine IXIARO is indicated for active immunisation against JE virus for persons 18years of age and older. It is a purified inactivated state-of-the-art JE vaccine that uses cell culture technology. It provides a good immune response while being generally well tolerated. The vaccine is provided as a ready-to-use liquid formulation in pre-filled syringes and is administered in two doses 28 days apart. About Japanese Encephalitis (JE) Japanese Encephalitis (JE) disease is an acute inflammatory condition of the brain and spinal cord caused by the Japanese Encephalitis virus. Most JE virus infections are mild (fever and headache) or without apparent symptoms, but approximately one in 300 infections results in severe disease characterised by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. [1] The fatality rate is approximately 30% and as many as 50% of those who survive suffer from persistent neurological sequelae. [2] In areas where the JE virus is common, encephalitis occurs mainly in young children because older children and adults are likely to have acquired natural immunity (through infection) or have been vaccinated. JE is a leading cause of viral encephalitis in Asia with 30,000 to 50,000 clinical cases reported annually. [10]. JE virus is only transmitted by certain types of mosquitoes (most commonly Culex tritaeniorhynchus). These mosquitoes are usually found in rural rice-growing and pig farming regions of Asia, but can also be found at the outskirts of cities. [4] The mosquitoes become infected by feeding on domestic pigs and wild birds that are infected with the JE virus. Infected mosquitoes then transmit the JE virus to other pigs and water birds, such as herons, and also to humans during feeding. [11]. The nature of the JE life cycle means it is not possible to eradicate JE. The transmission of JE is linked to the seasonality of the mosquitoes in these areas. JE is transmitted seasonally in large areas of Asia, but in some locations may be transmitted year round. Many areas with tropical climates hold a potential for year round transmission and, elsewhere, peak periods of increased viral transmission follows monsoon seasons and irrigation associated with rice cultivation. [11] JE is highly prevalent in Asia. Approximately 3 billion people live in areas at risk of the disease. JE has occurred from the islands of the Western Pacific in the east to the Pakistani border in the west, and from Korea in the north to Papua, New Guinea in the south. [4] References 1. PATH. JE in depth. http://www.path.org/projects/JE_in_depth.php 2008 2. Centers for Disease Control and Prevention. Travelers" Health: Yellow Book; Chapter 4, Japanese Encephalitis. http://www.cdc.gov/travel/yellowBookCH4-JapaneseEncephalitis.aspx 2007 3 Health Protection Agency and National Travel Health Network and Centre factsheet Japanese Encephalitis July 2008. Accessed March 2009. Available online at http://www.nathnac.org/travel/factsheets/japanese_enc.htm 4 Burdon JT, Stanley PJ, Lloyd G, Jones NC. A case of Japanese encephalitis. J Infect 1994Íõ28:1759. 5 World Tourism Organisation 2006 6 Tauber, E. Kollaritsch, H. Korinel, M. et al. Safety and immunogenicity of a Vero-cell derived, inactivated Japanese encephalitis vaccine: a non-inferiority, Phase III, randomized control trial Lancet 370[9602], 1847-1853. 1-12, 2007 7 Schuller, E., Jilma, B., Voicu, V. et al. Long-term immunogenicity of the new Vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51: six and 12 month results of a multicenter follow-up phase 3 study. Vaccine. 2008. Aug 12;26(34):4382-6 8 Tauber E, Kollaritsch H, von Sonnenburg F et al. Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of the Safety and Tolerability of IC51, an Inactivated Japanese Encephalitis Vaccine. J Infect Dis 2008; 198:493-499 9 Dubuscgar-Kastner, K., Kaltenboeck, A., Schuller, E. et al. Six months Safety of a Vero-cell culture derived Japanese Encephalitis Vaccine, IXIARO, IC51, across Phase 3 trials and in a long term-follow up cohort. Abstracts of the 57th American Society for Tropical Medicine and Hygiene annual meeting, New Orleans, LA, USA, December 7-11, 2008 10 http://cdc.gov/ncidod/dvbid/jencephalitis/facts.htm 11 Solomon,Pages: [1] 2