摘要:

The pre-S1 and -S2 domains are thought to be important factors in the immunogenicity of hepatitis B virus vaccines. Epitec developed a product which contains pre-S1, pre-S2 and S epitopes. The rights to Epitec's third generation recombinant hepatitis B virus vaccine (HepageneTM) now belong to Medeva.Medeva is developing HepageneTMfor both prophylaxis and therapy of hepatitis B. Phase III trials in the prophylactic indication have been completed in the UK. A pan-European product licence application for the prophylactic use of HepageneTMwas submitted in 1998. A biologics licence application to the US Food and Drug Administration for HepageneTMwas submitted in 1999. More information has been requested for both applications.HepageneTMis also in clinical trials in Indonesia (with Janssen Pharmaceutica), Europe and North America as an immunotherapy for chronic carriers of hepatitis B.HepageneTMis a novel third generation hepatitis B vaccine which will be useful to immunise subjects who have not responded to existing vaccines, who need more rapid protection than the latter vaccines can provide or for whom compliance with a full administration regimen of these vaccines presents difficulties (HepageneTMprovides the first 2-dose, 1-month regimen for hepatitis B vaccination compared with 3-dose, 6-month regimens required with existing vaccines). According to Medeva, HepageneTMcontains the full complement of hepatitis B virus surface antigens and has the potential to produce a better immune response than the current recombinant products which contain only 1 of the surface antigens of the virus. However, HepageneTMis considerably more expensive to produce than the current vaccines. The vaccine will thus be targeted at inadequate responders to existing vaccines, high risk health care workers, families of hepatitis B infected people, immunocompromised patients, IV drug users, sexually transmitted disease clinic patients and travel clinics.Since a court ruling that Medeva infringed Biogen's hepatitis B patent has been reversed, Medeva will now be able to develop and manufacture HepageneTMin the UK and export it to 6 other European countries and the Far East where Biogen does not have patents. Biogen's US patent lasts until 2004 and its European patent expires at the end of 1999.Janssen is to be Medeva's partner for the codevelopment and marketing of HepageneTMin the Asia-Pacific region excluding Japan.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Wyeth-Lederle Vaccines and Pediatrics has submitted a product licence application to the US Food and Drug Administration for its new 4-component vaccine (TetracelTM) for the prevention of diphtheria, tetanus, pertussis andHaemophilus influenzaetype B meningitis in infants 12 to 18 months old.TetracelTMcombines Wyeth-Lederle's diphtheria tetanus and acellular pertussis (Acel-Immune®) andHaemophilus influenzaetype B (HibTITER®) vaccines. The pertussis component consists of pertussis toxin, filamentous haemagglutinin, pertactin and agglutinogen and is manufactured by Takeda. Wyeth-Lederle claims that TetracelTMis safe and offers the convenience of single-dose administration.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Aviron has signed a Collaborative Research and Development Agreement with the US National Institute of Allergy and Infectious Diseases, and a licensing agreement with the University of Michigan, Ann Arbor, USA, to complete the development of a cold-adapted live influenza virus vaccine (FluMistTM) that can be administered by nasal spray.Aviron submitted its first product licence application to the US Food and Drug Administration (FDA) for FluMistTMin 1998, and will submit a biologics licence application in 1999. Preliminary results of a bridging study indicated that the lot of FluMistTMblended and filled at Packaging Coordinators, Inc. in Philadelphia had similar immunogenicity and tolerability for all 3 1997-1998 influenza strains as the vaccine used in earlier clinical trials which was manufactured by Medeva in the UK. The company is seeking US licensure for FluMistTMto prevent influenza and its complications in children and adults, and for coadministration with the inactivated flu vaccine in the elderly.The vaccine consists of a recombinant attenuated live virus (A/Ann Arbor/6/60 or B/Ann Arbor/1/66) expressing haemagglutinin from 1 or more virulent influenza strains. It triggers stronger, more long-lasting local immune protection than the conventional killed virus vaccine. The vaccine is termed cold-adapted because the virus has been adapted to proliferate and trigger antibodies in the nasal passages, which are below normal body temperature. The cold-adapted live influenza vaccine has been widely evaluated in the US and Japan since 1975, in clinical trials involving more than 7000 people. Aviron has completed phase II clinical trials in adults in the US and phase III trials in US children aged 15 to 71 months. Additional phase III trials in adults and elderly are ongoing. Aviron has also commenced phase III trials to test the safety of its intranasal live vaccine in children with moderate to severe asthma.The vaccine will be delivered using a novel spray syringe which releases a large particle aerosol spray (the AccuSpray nasal delivery system by Becton Dickinson).Aviron holds exclusive worldwide rights to the vaccine except for Japan, where Kaketsuken Pharmaceuticals is the licensee. Sang-A will manufacture and market Aviron's influenza vaccine in Korea. Medeva Pharma (formerly Evans Medical) are to manufacture the components of FluMistTMin the UK. Packaging Coordinators, Inc. (Cardinal subsidiary) will carry out secondary manufacturing of the vaccine in the US. CSL Ltd of Australia will collaborate on the development, sale and distribution of Aviron's vaccine in the South Pacific. Aviron has also entered into an agreement with Wyeth-Lederle for worldwide collaboration in the marketing of Flu-MistTM, excluding Korea, Australia, New Zealand and certain South Pacific countries.FluMistTM, a live attenuated influenza virus vaccine, offers significant advantages over currently marketed influenza vaccines consisting of inactivated viruses. Unlike these vaccines, it triggers mucosal immune responses in addition to systemic responses, stimulating stronger, longer-lasting immune protection. In addition, the intranasal administration of FluMistTMis more convenient and tolerable for recipients than the injections required with current influenza vaccines.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Tropical Disease Research, (a collaboration between World Health Organisation, United Nations Development Programme and the World Bank) is conducting phase III studies in Sudan, Iran and Pakistan with a vaccine comprising whole-cell killedLeishmania majorwith or without BCG as an adjuvant for the prophylaxis of cutaneous or visceral leishmaniasis. Vaccine for the field trial is being produced by the Razi Serum Institute in Iran.UK researchers are also developing an oral vaccine against visceral leishmaniasis by transfection for theL. majorpromastigote glycoprotein 63 (gp63) gene into a double deletion (aroA-/aroD-) mutant ofSalmonella typhimurium. This vaccine preferentially induced a T helper-1 cell response.Scientists in Brazil (Universidae Federal de Minas Gerais) also appear to be conducting clinical investigations with a vaccine for the prophylaxis of cutaneous leishmaniasis. The vaccine consists of whole antigens from killed promastigotes from 5 different strains ofL. braziliensisand appears to induce both humoral and cellular immune responses.Researchers at the Universidad Autonoma de Campeche in Mexico are investigating the immunogenicity of a subunit vaccine against cutaneous leishmaniasis. The vaccine consists of gp63 from the promastigotes ofL. major mexicanaencapsulated in liposomes. Preclinical trials are ongoing.Scientists from several nonindustrial institutes in Israel including the Weizman Institute of Science and the Hebrew University in Jerusalem, Israel, have also reported successful immunisation of animal models of cutaneous leishmaniasis with a subunit vaccine containing a peptide fragment of gp63 (fromL. majorstrain WR 1045) consisting off amino acids 467-482 (p467) adjuvanted to lauryl-cysteine.A vaccine to treat leishmaniasis was undergoing preclinical development with researchers at 2 US nonindustrial centres, the Washington School of Medicine, St Louis, Missouri and the Albert Einstein College of Medicine in New York. The vaccine consisted of a leishmania gene inserted into BCG. There has been no recent evidence of continued active development of this vaccine.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Pasteur Mérieux Connaught has licensed a recombinant BCG Lyme disease vaccine from Symbicom. The vaccine (ImuLymeTM) has completed phase III clinical trials in the US and Pasteur Mérieux Connaught has filed a product licence application with the US FDA.Lyme disease is a common tick-borne disease caused byBorrelia burgdorferiand transmitted by the bite of certain ticks. ImuLymeTM, which contains outer surface protein (OspA) ofB. burgdorferi, is designed for patients older than 2 years. Pasteur Mérieux Connaught holds exclusive worldwide rights to the technology for OspA-based vaccines through a licensing agreement with Symbicom.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Group C meningococci are an important cause of meningitis in infants. Licensed polysaccharide vaccines are poorly immunogenic in infants <24 to 36 months of age. Wyeth-Lederle Vaccines and Pediatrics is developing a heptavalent meningococcal conjugate vaccine for prophylaxis of group C meningococcal infection. The vaccine consists of meningococcal polysaccharide linked to the diphtheria toxoid CRM197, a protein carrier to enhance the immunogenic response.On 6 May 1999, Wyeth-Lederle announced that it had submitted a product licence application in the UK for use of its meningococcal C conjugate vaccine in the prevention of meningococcal systemic type C disease.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Wyeth-Lederle Vaccines and Pediatrics is developing a conjugate pneumococcal vaccine againstStreptococcus pneumoniaeinfections, a cause of pneumonia, bacterial meningitis and ear infection in the young and the elderly. The vaccine consists ofS. pneumoniaepolysaccharides linked to diphtheria cross-reacting molecule 197 (CRM197). The early version of the vaccine was pentavalent (PNCRM5) but Wyeth-Lederle has since developed a more effective heptavalent version (PNCRM7) which is in preregistration in the US for prevention of pneumococcal infections and otitis media. Phase III clinical trials with PNCRM7 are also underway in Finland for prevention of otitis media and invasive pneumococcal disease.Although polysaccharide pneumococcal vaccines are available in the market they are not recommended for use in children under the age of 2 years because of poor immunogenicity. Wyeth-Lederle's conjugate vaccine has improved immunogenicity and may be incorporated into routine childhood immunisation schedules.On 21 July 1999, Wyeth-Lederle announced that its product licence application (PLA) for PNCRM7 had gained priority review status from the US Food and Drug Administration (FDA). Priority review status means that the FDA has established a goal to act on the PLA within 6 months of its date of submission, which occurred on 1 June 1999. This is the first time the FDA has assigned priority review status to a vaccine. Wyeth-Lederle believes that the vaccine will be on the market by the end of 1999. It had previously been announced on 12 March 1999 that the FDA had designated PNCRM7 for the ‘fast-track’ development programme. This programme is designed to facilitate development and expedite review of new drugs that are intended to treat serious conditions. Under the fast-track rules, Wyeth-Lederle was able to file a ‘rolling’ PLA which allowed the FDA to evaluate individual components of a licence application before the entire application was submitted.Wyeth-Lederle also appears to be developing a nonavalent version of its pneumococcal conjugate vaccine (PNCRM9).PNCRM7 is potentially a major clinical advance in prevention ofStreptococcal pneumoniaeinfections, as indicated by its fast-track designation by the FDA. Unlike commercially available vaccines, PNCRM7containsS. pneumoniaepolysaccharides conjugated to an immunogenic protein, resulting in a highly immunogenic and protective vaccine, particularly in young children, for whom current pneumococcal vaccines provide little protection. PNCRM7 was 100% protective in a large-scale field trial and exhibited very few adverse effects. In addition, the vaccine significantly reduced the frequency of otitis media in children.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Rotaviruses are a major cause of gastroenteritis in infants and children. In the US, Australia and Japan, 34 to 63% of hospitalisations of children for acute diarrhoeal diseases are associated with rotavirus infection. An effective vaccine would therefore have a major impact. Live attenuated bovine rotavirus vaccines have had variable protective efficacy in clinical trials. A reassortant human bovine vaccine containing the bovine rotavirus WC3 and the human serotype G1 rotavirus W179 (W179-9) is under phase III development with Merck & Co and the National Institutes of Health in the US. The vaccine appears to be highly effective in the prevention of clinically significant serotype G1 human rotavirus infection.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS

摘要:

Scientists at 2 research institutes in the US, the Walter Reed Army Institute of Research and the National Institutes of Health, and those at the Israel Defence Force are conducting phase III investigations with a conjugated vaccine againstShigella sonnei. The vaccine consists ofS. sonnei O-specific polysaccharide conjugated toPseudomonas aeruginosaexoprotein A (rEPA). TheS. sonnei-rEPA conjugate vaccine has proved to be well tolerated and immunogenic in volunteers.

ISSN:1174-5886    

出版商:ADIS    

年代:1999

数据来源: ADIS