Sanofi says H5N1 vaccine with adjuvant may go further

first_imgEditor’s note: The title and first two paragraphs of this story were revised Dec 16 to correct a statement in the original that gave a more positive reflection of the trial results described below than may be warranted. The original version said that Sanofi Pasteur had described the trial results as “promising,” but the company actually said only that the results were “a sign of progress.”Dec 15, 2005 (CIDRAP News) – Sanofi Pasteur today announced preliminary trial results suggesting that using an additive to boost the immune response may help to stretch the supply of a vaccine for H5N1 avian influenza by a modest amount.Previous results had indicated that an H5N1 vaccine without an immune-boosting adjuvant would have to contain 12 times as much antigen (active ingredient) as seasonal flu vaccines do. In the results announced today, it took four times as much antigen as in a seasonal flu vaccine to induce an adequate immune response—an improvement, but far from what is needed to remedy the global shortage of vaccine production capacity.Sanofi tested an H5N1 vaccine it is making for the French government on 300 volunteers, using three different doses: 7.5, 15, and 30 micrograms. The volunteers were divided into six groups, and each group received two doses of vaccine with or without alum, an adjuvant used in many vaccines, according to Len Lavenda, US spokesman for Sanofi. The shots were given 3 weeks apart.”A 30-microgram dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine,” the company said in a news release.The two 30-microgram doses of vaccine containing alum induced an immune response in line with what the European Agency for Evaluation of Medicinal Products (EMEA) requires for flu vaccines, Lavenda told CIDRAP News.”We saw responses in all six groups, but the two-30-microgram-dose adjuvant group was the only one within the range of EMEA approval,” he said.”The 7.5- and 15-microgram studies provided results that were not as high as the 30, but we are continuing to study that data and we expect to publish the full set within a few months,” Lavenda said.Seasonal flu vaccines typically contain 15 micrograms of antigen, the active ingredient, for each viral strain covered. The amount that proved adequate in the Sanofi trial was 60 micrograms (two 30-microgram doses), four times as much.However, 60 micrograms is a much smaller amount than what was found to be adequate in a trial of an H5N1 vaccine that Sanofi is producing for the US government, according to results announced in August. In that trial, which didn’t involve an adjuvant, the regimen that looked most promising was two 90-microgram doses, a total of 180 micrograms.H5N1 vaccines are being developed in the hope that they will be protective if the H5N1 virus evolves into a pandemic strain. But even if the current experimental vaccines turn out be effective, the world’s current production capacity is far too small to provide enough vaccine for more than a small fraction of the population, according to disease experts. Researchers hope that dose-sparing tools such as adjuvants will help stretch the supply.Sanofi called the new trial results “a sign of progress” that will help guide further development of a pandemic flu vaccine. “Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies,” the company said.The vaccine used in the latest trial is being developed to provide a stockpile for the French government, the company said. It comes from a different human isolate of H5N1 virus than the one used in the vaccine Sanofi is making for the United States, according to Lavenda.See also:Aug 8, 2005, CIDRAP News story “Hopeful news on human H5N1 vaccine, but production concerns considerable”last_img read more

The people of Križevci proactively started the development of cycling tourism

first_imgYou can see the list of trails at Google Maps , and you can download GPX and KMP tracks on the site Križevci Cyclists’ Association. You either play the game or you don’t. The people of Križevci see their opportunity in cyclotourism, and step by step they are actively working on its development. And the great news is that the Action Plan was not made “pro forma” nor did it collect dust in the drawer, but they immediately started implementing it. Also, since last month at the Tourist Information Center in Križevci, visitors can rent four mountain and four mountain hybrid electric bicycles and ride the bike paths of Križevci and Kalnički prigorje on a bicycle. The Tourist Board of the City of Križevci invites interested parties to apply for participation in the training and send their applications to tz@krizevci.hr. Also, it is extremely important that the Križevci Cyclists’ Association (KUB) is active in Križevci, and that they are an active partner in the development of all cycling documents and plans, as well as the organizers of various cycling races in the city of Križevci. The City of Križevci and the Tourist Board of the City of Križevci, in cooperation with partners, this year have developed an Action Plan for the development of cycling tourism until 2025. Education of bicycle guides of Podravina and Prigorje As they point out from the Tourist Board of the city of Križevci, the education will cover a wide range of material: theoretical, practical and field work. Teaching topics such as: the relationship of a bicycle guide to a guest cyclist, guide equipment, group leadership, cartography and orientation (theory and practice), making tourist package deals, basics of physiology and nutrition, first aid, legislation, basics about bicycles ( types, parts, body position, adjustment, e-bike), riding technique and polygon, field service, etc. “In Križevci, we have been working intensively on the development of cycling tourism for several years. One of the two cycling projects where hiking and biking trails have been built has just been completed. We have also published the first series of brochures in five foreign languages, which promote 10 cycling trails. Also, this is the first step, and we are currently preparing the further development of the entire tourism and cycling infrastructure through EU funds. The most important thing is that after a lot of effort we finally see a positive shift in the arrival of cyclists who explore Križevci and Kalničko prigorje”Points out Olinka Gjigaš, director of the Križevci Tourist Board, and adds that things can certainly only get better in accordance with the implementation of the Action Plan for the development of cycling tourism and further investment in the promotion and development of cycling tourism. center_img Bicycle clubs and associations are the bearers of the development of cycling tourism in every destination, and without them it is certainly difficult and almost impossible to develop cycling tourism. They actively “live” cycling tourism from day to day, know and maintain trails, connect with other cyclists and with the support of the city and the tourist community form the backbone of the development of cycling tourism. Of course, as always, it is up to us whether we want market development or not. Funding is always a major issue, but again, it is important to be proactive and strive for development in line with current resources and opportunities. The Ministry and the CNTB encourage and co-finance cycling projects, there are various EU funds, and certainly how the role of the city and the Tourist Board is crucial in all activities. The city as one of the main investors in tourism infrastructure must understand that investing in tourism development as well as cycling tourism is an investment, not a cost. In Croatia we have the knowledge, successful business models, companies, products and individuals to develop cycling tourism. So, we have everything, the only question is whether we want to deal with market development or not. Just marking the cycling tourism maps on the brochure cannot be called as the development of cycling tourism, there is a whole standard for how cycling tourism develops. As the financial resources for the education of bicycle guides are provided through co-financing from the Croatian National Tourist Board, access to the education is free. Thus, one of the first steps in the implementation of the Action Plan was the construction of pedestrian and bicycle paths in Križevci, which have just been presented to the public. Namely, within the EU project Cyclo-Net, new 4,35 kilometers of bicycle paths were built in Križevci and the construction of a bicycle bridge over the Vrtlin stream in Ivana Gundulića Street and the continuation of the access road on Ratarna from the lookout to Potočka Street. As part of the above-mentioned Action Plan for the development of cycling tourism, in addition to the above-mentioned already implemented activities, it was detected that the destination lacks educated cycling guides. That is why the Tourist Board of the City of Križevci is launching a training program for bicycle guides, which will be held in cooperation with the Istrian Development Tourist Agency (IRTA doo) during the month of September 2019 through two weekends in Križevci and its surroundings. The head of the training program is the alpha and omega development of cycling tourism in Croatia, Martin Čotar, a Croatian cyclist and the head of the Bike and Outdoor department of the Istrian Development Tourist Agency.  Photo: Križevci Tourist Boardlast_img read more