Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults
Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, whic...
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| Veröffentlicht in: | The Journal of infectious diseases 1998-03, Vol.177 (3), p.796-799 |
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| container_title | The Journal of infectious diseases |
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| creator | Savarino, Stephen J. Brown, F. Matthew Hall, Eric Bassily, Samir Youssef, Fouad Wierzba, Thomas Peruski, Leonard El-Masry, Nabil A. Safwat, Mohammed Rao, Malla Jertborn, Marianne Svennerholm, Ann-Mari Lee, Young J. Clemens, John D. |
| description | Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21–45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting. |
| doi_str_mv | 10.1086/517812 |
| format | Article |
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Matthew ; Hall, Eric ; Bassily, Samir ; Youssef, Fouad ; Wierzba, Thomas ; Peruski, Leonard ; El-Masry, Nabil A. ; Safwat, Mohammed ; Rao, Malla ; Jertborn, Marianne ; Svennerholm, Ann-Mari ; Lee, Young J. ; Clemens, John D.</creator><creatorcontrib>Savarino, Stephen J. ; Brown, F. Matthew ; Hall, Eric ; Bassily, Samir ; Youssef, Fouad ; Wierzba, Thomas ; Peruski, Leonard ; El-Masry, Nabil A. ; Safwat, Mohammed ; Rao, Malla ; Jertborn, Marianne ; Svennerholm, Ann-Mari ; Lee, Young J. ; Clemens, John D.</creatorcontrib><description>Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21–45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting.</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/517812</identifier><identifier>PMID: 9498468</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adult ; Age groups ; Antibodies, Bacterial - blood ; Antigens ; Bacterial Vaccines - immunology ; Bacteriology ; Biological and medical sciences ; Blood ; Concise Communications ; Diarrhea ; Dosage ; Egypt ; Escherichia coli ; Escherichia coli - immunology ; Experimentation ; Female ; Fundamental and applied biological sciences. Psychology ; Humans ; Immune response ; Immunoglobulin A - blood ; Male ; Microbiology ; Middle Aged ; Placebos ; Vaccination ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies ; Vaccines, Synthetic - immunology</subject><ispartof>The Journal of infectious diseases, 1998-03, Vol.177 (3), p.796-799</ispartof><rights>Copyright 1998 The University of Chicago</rights><rights>1998 INIST-CNRS</rights><rights>Copyright University of Chicago, acting through its Press Mar 1998</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c423t-8740781db0daa75a7d90e3bdbca1a79d6d3680045c7875ff32dab2c78966df273</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/30106936$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/30106936$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,803,27923,27924,58016,58249</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2174922$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9498468$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Savarino, Stephen J.</creatorcontrib><creatorcontrib>Brown, F. Matthew</creatorcontrib><creatorcontrib>Hall, Eric</creatorcontrib><creatorcontrib>Bassily, Samir</creatorcontrib><creatorcontrib>Youssef, Fouad</creatorcontrib><creatorcontrib>Wierzba, Thomas</creatorcontrib><creatorcontrib>Peruski, Leonard</creatorcontrib><creatorcontrib>El-Masry, Nabil A.</creatorcontrib><creatorcontrib>Safwat, Mohammed</creatorcontrib><creatorcontrib>Rao, Malla</creatorcontrib><creatorcontrib>Jertborn, Marianne</creatorcontrib><creatorcontrib>Svennerholm, Ann-Mari</creatorcontrib><creatorcontrib>Lee, Young J.</creatorcontrib><creatorcontrib>Clemens, John D.</creatorcontrib><title>Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><description>Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21–45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting.</description><subject>Adult</subject><subject>Age groups</subject><subject>Antibodies, Bacterial - blood</subject><subject>Antigens</subject><subject>Bacterial Vaccines - immunology</subject><subject>Bacteriology</subject><subject>Biological and medical sciences</subject><subject>Blood</subject><subject>Concise Communications</subject><subject>Diarrhea</subject><subject>Dosage</subject><subject>Egypt</subject><subject>Escherichia coli</subject><subject>Escherichia coli - immunology</subject><subject>Experimentation</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunoglobulin A - blood</subject><subject>Male</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Placebos</subject><subject>Vaccination</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</subject><subject>Vaccines, Synthetic - immunology</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUtvEzEAhC0EKmmBf4BkIdQTC37s-nEsIdCKhh5aEOJieW1v47C7DrZXam78dFwSBcSFk-WZT2OPBoBnGL3GSLA3DeYCkwdghhvKK8YwfQhmCBFSYSHlY3Cc0hohVFPGj8CRrKWomZiBn9e6c3kL9WjhxTBMY7h1oze-SKErKryKun8FP_q-dxYuxuxiyOHO_6bgIpmVi96svIYm9L6ar0LvooY3BRnhW3g9tdPoM_yijfGjg0Vc3G432ZfkMzv1OT0BjzrdJ_d0f56Az-8XN_Pz6vLqw8X87LIyNaG5ErxGpaBtkdWaN5pbiRxtbWs01lxaZikTpV5juOBN11FidUvKRTJmO8LpCTjd5W5i-DG5lNXgk3F9r0cXpqS45KSh5a3_gZgR0SDECvjiH3AdpjiWEooQKnGDa_wnzcSQUnSd2kQ_6LhVGKn74dRuuAI-36dN7eDsAdsvVfyXe18no_su6tH4dMAI5rUkf8WsUw7xYFOEEZP0_tPVzvcpu7uDr-N3xTjljTr_-k0JgT-9W7KlWtJfXC23HQ</recordid><startdate>19980301</startdate><enddate>19980301</enddate><creator>Savarino, Stephen J.</creator><creator>Brown, F. 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Matthew ; Hall, Eric ; Bassily, Samir ; Youssef, Fouad ; Wierzba, Thomas ; Peruski, Leonard ; El-Masry, Nabil A. ; Safwat, Mohammed ; Rao, Malla ; Jertborn, Marianne ; Svennerholm, Ann-Mari ; Lee, Young J. ; Clemens, John D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c423t-8740781db0daa75a7d90e3bdbca1a79d6d3680045c7875ff32dab2c78966df273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Adult</topic><topic>Age groups</topic><topic>Antibodies, Bacterial - blood</topic><topic>Antigens</topic><topic>Bacterial Vaccines - immunology</topic><topic>Bacteriology</topic><topic>Biological and medical sciences</topic><topic>Blood</topic><topic>Concise Communications</topic><topic>Diarrhea</topic><topic>Dosage</topic><topic>Egypt</topic><topic>Escherichia coli</topic><topic>Escherichia coli - immunology</topic><topic>Experimentation</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunoglobulin A - blood</topic><topic>Male</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Placebos</topic><topic>Vaccination</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies</topic><topic>Vaccines, Synthetic - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Savarino, Stephen J.</creatorcontrib><creatorcontrib>Brown, F. 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Matthew</au><au>Hall, Eric</au><au>Bassily, Samir</au><au>Youssef, Fouad</au><au>Wierzba, Thomas</au><au>Peruski, Leonard</au><au>El-Masry, Nabil A.</au><au>Safwat, Mohammed</au><au>Rao, Malla</au><au>Jertborn, Marianne</au><au>Svennerholm, Ann-Mari</au><au>Lee, Young J.</au><au>Clemens, John D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults</atitle><jtitle>The Journal of infectious diseases</jtitle><addtitle>The Journal of Infectious Diseases</addtitle><date>1998-03-01</date><risdate>1998</risdate><volume>177</volume><issue>3</issue><spage>796</spage><epage>799</epage><pages>796-799</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>Enterotoxigenic Escherichia coli (ETEC) is the leading cause of bacterial diarrhea in young children in developing countries. The safety and immunogenicity of a killed, oral ETEC vaccine consisting of whole cells plus recombinantly produced cholera toxin B subunit (rCTB) was evaluated in Egypt, which is endemic for ETEC diarrhea. Seventy-four healthy Egyptian adults (21–45 years old) were randomized and received two doses of the ETEC/rCTB vaccine (E003) or placebo 2 weeks apart. The frequency of adverse events after either dose did not differ by treatment group, and no severe adverse events were reported. After vaccination, peripheral blood IgA B cell responses to CTB (100%) and to vaccine colonization factor antigens CFA/I (94%), CS4 (100%), CS2 (81%), and CS1 (69%) were significantly higher than response rates for the placebo group. These favorable results in Egyptian adults indicate that the ETEC/rCTB vaccine is a promising candidate for evaluation in younger age groups in this setting.</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>9498468</pmid><doi>10.1086/517812</doi><tpages>4</tpages></addata></record> |
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| source | MEDLINE; JSTOR Archive Collection A-Z Listing; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adult Age groups Antibodies, Bacterial - blood Antigens Bacterial Vaccines - immunology Bacteriology Biological and medical sciences Blood Concise Communications Diarrhea Dosage Egypt Escherichia coli Escherichia coli - immunology Experimentation Female Fundamental and applied biological sciences. Psychology Humans Immune response Immunoglobulin A - blood Male Microbiology Middle Aged Placebos Vaccination Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies Vaccines, Synthetic - immunology |
| title | Safety and Immunogenicity of an Oral, Killed Enterotoxigenic Escherichia coli-Cholera Toxin B Subunit Vaccine in Egyptian Adults |
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