Obiettivo The objective of the proposed research is to facilitate the development of a new oral cholera vaccine that would effectively and without any adverse reactions give high and sustained levels of immune protection against cholera caused by both Vibrio cholerae of the common 01 El Tor type and of the rapidly emerging, novel 0139 serotype. There is an urgent need for an effective cholera vaccine. Parenteral whole-cell vaccines against cholera have existed for almost a century, but these vaccines are no longer considered useful from a public health standpoint, mainly because of the short duration of protection they provide. Intense research efforts in the 1980ies have now provided much improved oral cholera vaccines based on either a combination of killed cholera bacteria and purified B-subunit antigen, or on live attenuated mutants of V.cholerae 01. In particular, the oral B subunit-whole cell (B-WC) cholera vaccine developed in Sweden has been extensively tested and shown to give much better and more long-lasting immunity than seen with previous parenteral cholera vaccines, and this is now an approved licensed vaccine in Sweden. The most advanced of the live attenuated cholera vaccine candidates, CVDl03-HgR developed in USA, has also given promising results when tested in volunteers. However, neither of these vaccines are likely to give more than partial (the B-Ol WC vaccine) or nil (the CVD103-HgR vaccine) protection against cholera due to an emerging, rapidly spreading new serotype (0139) of V. chlolerae which is now threatening to cause a new, the 8th, cholera pandemic coinciding with the still continuing 7th pandemic. Based on recent work on the new 0139 V. cholerae serotype organism researchers at the University of Goteborg, Sweden in collaboration with SBL Vaccine, Stockholm, are currently formulating a "new" bivalent oral B subunit - 01/0139 whole cell (WC) cholera vaccine with promising potential to give protection against both 01 and 0139 cholera. The vaccine is the same as the previous B-01 WC except for now also comprising 5x101ø heat- or formalin-killed 0139 bacteria of a strain selected to stably express high levels of 0139 LPS and MSHA surface antigens. Therefor, it is here proposed (1) to test the safety and intestinal mucosal IgA immunogenicity of this new, bivalent B-01/0139 WC vaccine in comparison with the licensed B-01 WC vaccine in phase 1 and phase 2 studies in volunteers in preparation for a possible field trial with the new vaccine; and (2) to undertake additional basic research to further define (in animals) the possible role of capsular antigen in immunity and vaccine development against cholera due to V. cholerae 0139 as well as the mucosal immunogenic potential of subunit conjugate vaccine formulations between cholera B subunit and 0139 and 01 LPS and 0139 capsular antigens. Campo scientifico natural sciencesbiological sciencesmicrobiologybacteriologymedical and health scienceshealth sciencespublic healthepidemiologypandemicsmedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines Programma(i) FP3-STD 3 - Specific research and technological development programme (EEC) in the field of the life sciences and technologies for developing countries, 1990-1994 Argomento(i) Data not available Invito a presentare proposte Data not available Meccanismo di finanziamento CSC - Cost-sharing contracts Coordinatore University of Göteborg Contributo UE Nessun dato Indirizzo 10,Guldhedsgatan 413 46 Gfteborg Svezia Mostra sulla mappa Costo totale Nessun dato Partecipanti (4) Classifica in ordine alfabetico Classifica per Contributo UE Espandi tutto Riduci tutto Institut National de la Santé et de la Recherche Médicale (INSERM) Francia Contributo UE Nessun dato Indirizzo 5 place d'Arsonval 69437 Lyon Mostra sulla mappa Costo totale Nessun dato International Centre for Diarrhoeal Disease Research Bangladesh Contributo UE Nessun dato Indirizzo 1000 Dhaka Mostra sulla mappa Costo totale Nessun dato Ludwig-Maximilians-Universität München Germania Contributo UE Nessun dato Indirizzo Leopoldstraße 5 80802 München Mostra sulla mappa Costo totale Nessun dato National Public Health Institute Finlandia Contributo UE Nessun dato Indirizzo 166,Mannerheimintie 00300 Helsinki Mostra sulla mappa Costo totale Nessun dato
