Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh
BackgroundA live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults MethodsThe study was conducted among adults, by use of a double-blind, randomized, placebo-c...
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| Veröffentlicht in: | The Journal of infectious diseases 2005-08, Vol.192 (4), p.573-579 |
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| creator | Qadri, Firdausi Chowdhury, Mohiul I. Faruque, Shah M. Salam, Mohammed A. Ahmed, Tanvir Begum, Yasmin A. Saha, Amit Alam, Mohammed S. Zaman, K. Seidlein, Lorenz V. Park, Eunsik Killeen, Kevin P. Mekalanos, John J. Clemens, John D. Sack, David A. |
| description | BackgroundA live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults MethodsThe study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (∼2×108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer ResultsStudy treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%–88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to |
| doi_str_mv | 10.1086/432074 |
| format | Article |
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A single dose of Peru-15 (∼2×108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer ResultsStudy treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%–88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected ConclusionsThe safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/432074</identifier><identifier>PMID: 16028125</identifier><identifier>CODEN: JIDIAQ</identifier><language>eng</language><publisher>Chicago, IL: The University of Chicago Press</publisher><subject>Adolescent ; Adult ; Antibodies ; Antibodies, Bacterial - blood ; Applied microbiology ; Bacteria ; Bacterial diseases ; Bacteriology ; Bangladesh ; Biological and medical sciences ; Cholera ; Cholera vaccine ; Cholera Vaccines - adverse effects ; Cholera Vaccines - immunology ; Female ; Fundamental and applied biological sciences. Psychology ; Human bacterial diseases ; Humans ; Immune response ; Immunization ; Immunoglobulin G - blood ; Immunoglobulin M - blood ; Infectious diseases ; Isotypes ; Male ; Medical sciences ; Microbiology ; Middle Aged ; Miscellaneous ; Placebos ; Transponders ; Tropical bacterial diseases ; Vaccination ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Vaccines, Attenuated - adverse effects ; Vaccines, Attenuated - immunology ; Vibrio cholerae ; Vibrio cholerae - immunology</subject><ispartof>The Journal of infectious diseases, 2005-08, Vol.192 (4), p.573-579</ispartof><rights>Copyright 2005 Infectious Diseases Society of America</rights><rights>2005 by the Infectious Diseases Society of America 2005</rights><rights>2005 INIST-CNRS</rights><rights>Copyright University of Chicago Press Aug 15, 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c578t-3d0967232e4e72088bce555367f31a5460afdc5000e6bdb0400460680312ac3e3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/30086259$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/30086259$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,803,27922,27923,58015,58248</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=17021190$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16028125$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Qadri, Firdausi</creatorcontrib><creatorcontrib>Chowdhury, Mohiul I.</creatorcontrib><creatorcontrib>Faruque, Shah M.</creatorcontrib><creatorcontrib>Salam, Mohammed A.</creatorcontrib><creatorcontrib>Ahmed, Tanvir</creatorcontrib><creatorcontrib>Begum, Yasmin A.</creatorcontrib><creatorcontrib>Saha, Amit</creatorcontrib><creatorcontrib>Alam, Mohammed S.</creatorcontrib><creatorcontrib>Zaman, K.</creatorcontrib><creatorcontrib>Seidlein, Lorenz V.</creatorcontrib><creatorcontrib>Park, Eunsik</creatorcontrib><creatorcontrib>Killeen, Kevin P.</creatorcontrib><creatorcontrib>Mekalanos, John J.</creatorcontrib><creatorcontrib>Clemens, John D.</creatorcontrib><creatorcontrib>Sack, David A.</creatorcontrib><creatorcontrib>Peru-15 Study Group</creatorcontrib><creatorcontrib>Peru-15 Study Group</creatorcontrib><creatorcontrib>Peru‐15 Study Group</creatorcontrib><title>Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><addtitle>The Journal of Infectious Diseases</addtitle><description>BackgroundA live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults MethodsThe study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (∼2×108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer ResultsStudy treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%–88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected ConclusionsThe safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antibodies</subject><subject>Antibodies, Bacterial - blood</subject><subject>Applied microbiology</subject><subject>Bacteria</subject><subject>Bacterial diseases</subject><subject>Bacteriology</subject><subject>Bangladesh</subject><subject>Biological and medical sciences</subject><subject>Cholera</subject><subject>Cholera vaccine</subject><subject>Cholera Vaccines - adverse effects</subject><subject>Cholera Vaccines - immunology</subject><subject>Female</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Human bacterial diseases</subject><subject>Humans</subject><subject>Immune response</subject><subject>Immunization</subject><subject>Immunoglobulin G - blood</subject><subject>Immunoglobulin M - blood</subject><subject>Infectious diseases</subject><subject>Isotypes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Placebos</subject><subject>Transponders</subject><subject>Tropical bacterial diseases</subject><subject>Vaccination</subject><subject>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</subject><subject>Vaccines, Attenuated - adverse effects</subject><subject>Vaccines, Attenuated - immunology</subject><subject>Vibrio cholerae</subject><subject>Vibrio cholerae - immunology</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0V-LEzEQAPBFFK9W_QZKFPSpq_mzSXYfa_F6B4WTOz3Fl5BuZq_b201qkhXrt_GbmtpyBUF8Csz8MsnMZNlTgt8QXIq3BaNYFveyEeFM5kIQdj8bYUxpTsqqOskehbDGGBdMyIfZCRGYloTyUfbrUlvj-vYnmAmaORu96zow6CoOZotcg-IK0JVuIG5Rkui87wfrbsC2dRv_gA_gh5zwCdJo0X4HNI0R7KBjKnLhdYeudV23FtAsXW9NiqPGeTRbuQ68nqDWoqkZuoiuXTfYCODDLvZO25tOGwirx9mDRncBnhzOcfbp9P3H2Vm-uJifz6aLvOayjDkzuBKSMgoFSIrLclkD5zz12zCieSGwbkzN0wxALM0SF2kYAosSM0J1zYCNs9f7uhvvvg0QourbUEPXaQtuCCpRzkop_wtJRWWJ01fG2cu_4NoN3qYmFKWswkXF8LFa7V0IHhq18W2v_VYRrHarVfvVJvj8UG1Y9mCO7LDLBF4dgA617hqvbd2Go5OYElLtXnyxd27Y_PuxZ3uzDtH5O8VwMpRXKZ_v822I8OMur_2tEpJJrs6-fFX8s5ifXi4qNWe_AcyAy44</recordid><startdate>20050815</startdate><enddate>20050815</enddate><creator>Qadri, Firdausi</creator><creator>Chowdhury, Mohiul I.</creator><creator>Faruque, Shah M.</creator><creator>Salam, Mohammed A.</creator><creator>Ahmed, Tanvir</creator><creator>Begum, Yasmin A.</creator><creator>Saha, Amit</creator><creator>Alam, Mohammed S.</creator><creator>Zaman, K.</creator><creator>Seidlein, Lorenz V.</creator><creator>Park, Eunsik</creator><creator>Killeen, Kevin P.</creator><creator>Mekalanos, John J.</creator><creator>Clemens, John D.</creator><creator>Sack, David A.</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><general>Oxford University Press</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7QL</scope><scope>C1K</scope><scope>7X8</scope></search><sort><creationdate>20050815</creationdate><title>Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh</title><author>Qadri, Firdausi ; Chowdhury, Mohiul I. ; Faruque, Shah M. ; Salam, Mohammed A. ; Ahmed, Tanvir ; Begum, Yasmin A. ; Saha, Amit ; Alam, Mohammed S. ; Zaman, K. ; Seidlein, Lorenz V. ; Park, Eunsik ; Killeen, Kevin P. ; Mekalanos, John J. ; Clemens, John D. ; Sack, David A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c578t-3d0967232e4e72088bce555367f31a5460afdc5000e6bdb0400460680312ac3e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antibodies</topic><topic>Antibodies, Bacterial - blood</topic><topic>Applied microbiology</topic><topic>Bacteria</topic><topic>Bacterial diseases</topic><topic>Bacteriology</topic><topic>Bangladesh</topic><topic>Biological and medical sciences</topic><topic>Cholera</topic><topic>Cholera vaccine</topic><topic>Cholera Vaccines - adverse effects</topic><topic>Cholera Vaccines - immunology</topic><topic>Female</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Human bacterial diseases</topic><topic>Humans</topic><topic>Immune response</topic><topic>Immunization</topic><topic>Immunoglobulin G - blood</topic><topic>Immunoglobulin M - blood</topic><topic>Infectious diseases</topic><topic>Isotypes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Placebos</topic><topic>Transponders</topic><topic>Tropical bacterial diseases</topic><topic>Vaccination</topic><topic>Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)</topic><topic>Vaccines, Attenuated - adverse effects</topic><topic>Vaccines, Attenuated - immunology</topic><topic>Vibrio cholerae</topic><topic>Vibrio cholerae - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Qadri, Firdausi</creatorcontrib><creatorcontrib>Chowdhury, Mohiul I.</creatorcontrib><creatorcontrib>Faruque, Shah M.</creatorcontrib><creatorcontrib>Salam, Mohammed A.</creatorcontrib><creatorcontrib>Ahmed, Tanvir</creatorcontrib><creatorcontrib>Begum, Yasmin A.</creatorcontrib><creatorcontrib>Saha, Amit</creatorcontrib><creatorcontrib>Alam, Mohammed S.</creatorcontrib><creatorcontrib>Zaman, K.</creatorcontrib><creatorcontrib>Seidlein, Lorenz V.</creatorcontrib><creatorcontrib>Park, Eunsik</creatorcontrib><creatorcontrib>Killeen, Kevin P.</creatorcontrib><creatorcontrib>Mekalanos, John J.</creatorcontrib><creatorcontrib>Clemens, John D.</creatorcontrib><creatorcontrib>Sack, David A.</creatorcontrib><creatorcontrib>Peru-15 Study Group</creatorcontrib><creatorcontrib>Peru-15 Study Group</creatorcontrib><creatorcontrib>Peru‐15 Study Group</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Environmental Sciences and Pollution Management</collection><collection>MEDLINE - Academic</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Qadri, Firdausi</au><au>Chowdhury, Mohiul I.</au><au>Faruque, Shah M.</au><au>Salam, Mohammed A.</au><au>Ahmed, Tanvir</au><au>Begum, Yasmin A.</au><au>Saha, Amit</au><au>Alam, Mohammed S.</au><au>Zaman, K.</au><au>Seidlein, Lorenz V.</au><au>Park, Eunsik</au><au>Killeen, Kevin P.</au><au>Mekalanos, John J.</au><au>Clemens, John D.</au><au>Sack, David A.</au><aucorp>Peru-15 Study Group</aucorp><aucorp>Peru-15 Study Group</aucorp><aucorp>Peru‐15 Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh</atitle><jtitle>The Journal of infectious diseases</jtitle><stitle>The Journal of Infectious Diseases</stitle><addtitle>The Journal of Infectious Diseases</addtitle><date>2005-08-15</date><risdate>2005</risdate><volume>192</volume><issue>4</issue><spage>573</spage><epage>579</epage><pages>573-579</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><coden>JIDIAQ</coden><abstract>BackgroundA live oral Vibrio cholerae O1 El Tor vaccine candidate, Peru-15, was studied for safety, immunogenicity, and excretion in phase 1 (inpatient) and phase 2 (outpatient) studies of Bangladeshi adults MethodsThe study was conducted among adults, by use of a double-blind, randomized, placebo-controlled design. A single dose of Peru-15 (∼2×108 cfu) or placebo (buffer only) was given in standard bicarbonate and ascorbic acid buffer ResultsStudy treatment did not elicit any major adverse events in the volunteers, during either the inpatient or the outpatient phases, and there were no reports of diarrhea. V. cholerae was isolated from the stool of only 1 volunteer and was found to be genetically identical to the vaccine strain. Vibriocidal antibody responses were seen in 30 (75%) of 40 vaccine recipients and in 3 (10%) of 30 placebo recipients. Peripheral blood immunoglobulin (Ig) A and IgM antibody-secreting cell responses to lipopolysaccharide were seen in the majority of vaccine recipients (response rate, 78%–88%). Seroconversion for lipopolysaccharide-specific IgA antibodies was seen in 88% of vaccine recipients. The response in vaccine recipients was significantly higher than that in placebo recipients, in all of the immunological assays (P=.036 to <.001). A lower immunological response against cholera toxin B subunit was detected ConclusionsThe safety and immunogenicity of this Peru-15 vaccine candidate indicates the usefulness of future studies in Bangladesh, where cholera is endemic</abstract><cop>Chicago, IL</cop><pub>The University of Chicago Press</pub><pmid>16028125</pmid><doi>10.1086/432074</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Journal of infectious diseases, 2005-08, Vol.192 (4), p.573-579 |
| issn | 0022-1899 1537-6613 |
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| source | MEDLINE; JSTOR Archive Collection A-Z Listing; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Adolescent Adult Antibodies Antibodies, Bacterial - blood Applied microbiology Bacteria Bacterial diseases Bacteriology Bangladesh Biological and medical sciences Cholera Cholera vaccine Cholera Vaccines - adverse effects Cholera Vaccines - immunology Female Fundamental and applied biological sciences. Psychology Human bacterial diseases Humans Immune response Immunization Immunoglobulin G - blood Immunoglobulin M - blood Infectious diseases Isotypes Male Medical sciences Microbiology Middle Aged Miscellaneous Placebos Transponders Tropical bacterial diseases Vaccination Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Vaccines, Attenuated - adverse effects Vaccines, Attenuated - immunology Vibrio cholerae Vibrio cholerae - immunology |
| title | Randomized, Controlled Study of the Safety and Immunogenicity of Peru-15, a Live Attenuated Oral Vaccine Candidate for Cholera, in Adult Volunteers in Bangladesh |
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