A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh
Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for end...
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| Veröffentlicht in: | Vaccine 2022-01, Vol.40 (4), p.640-649 |
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| creator | Chowdhury, Fahima Akter, Afroza Bhuiyan, Taufiqur Rahman Tauheed, Imam Teshome, Samuel Sil, Arijit Park, Ju Yeon Chon, Yun Ferdous, Jannatul Basher, Salima Raiyan Ahmed, Faez Karim, Mahbubul Ahasan, Mohammad Mainul Mia, Masudur Rahman Masud, Mir Mohammad Ibna Khan, Abdul Wahab Billah, Masum Nahar, Zebun Khan, Imran Ross, Allen G. Kim, Deok Ryun Ashik, Md. Muktadir Rahman Digilio, Laura Lynch, Julia Excler, Jean-Louis Clemens, John D. Qadri, Firdausi |
| description | Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1–5, 6–17 and 18–45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581. |
| doi_str_mv | 10.1016/j.vaccine.2021.12.015 |
| format | Article |
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Muktadir Rahman ; Digilio, Laura ; Lynch, Julia ; Excler, Jean-Louis ; Clemens, John D. ; Qadri, Firdausi</creator><creatorcontrib>Chowdhury, Fahima ; Akter, Afroza ; Bhuiyan, Taufiqur Rahman ; Tauheed, Imam ; Teshome, Samuel ; Sil, Arijit ; Park, Ju Yeon ; Chon, Yun ; Ferdous, Jannatul ; Basher, Salima Raiyan ; Ahmed, Faez ; Karim, Mahbubul ; Ahasan, Mohammad Mainul ; Mia, Masudur Rahman ; Masud, Mir Mohammad Ibna ; Khan, Abdul Wahab ; Billah, Masum ; Nahar, Zebun ; Khan, Imran ; Ross, Allen G. ; Kim, Deok Ryun ; Ashik, Md. Muktadir Rahman ; Digilio, Laura ; Lynch, Julia ; Excler, Jean-Louis ; Clemens, John D. ; Qadri, Firdausi</creatorcontrib><description>Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1–5, 6–17 and 18–45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2021.12.015</identifier><identifier>PMID: 34969541</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Administration, Oral ; Adverse events ; Age ; Antibodies ; Antibodies, Bacterial ; Bangladesh - epidemiology ; Cholera ; Cholera - epidemiology ; Cholera - prevention & control ; Cholera Vaccines ; Cholvax ; Clinical trial ; Clinical trials ; Disease ; Enrollments ; Health care ; Humans ; Immunization ; Immunogenicity ; Infant ; Non-inferiority ; OCV ; Oral vaccines ; Pathogens ; Pharmacists ; Phlebotomy ; Public private partnerships ; Serotypes ; Vaccines ; Vaccines, Inactivated - adverse effects ; Vibrio cholerae O1 ; Waterborne diseases</subject><ispartof>Vaccine, 2022-01, Vol.40 (4), p.640-649</ispartof><rights>2021 The Author(s)</rights><rights>Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.</rights><rights>2021. The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-b4e964b1b975d5ff74389e5298dde2531acb96144a57b41d5bbe834579b7e17e3</citedby><cites>FETCH-LOGICAL-c440t-b4e964b1b975d5ff74389e5298dde2531acb96144a57b41d5bbe834579b7e17e3</cites><orcidid>0000-0002-6394-9104</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0264410X21016236$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34969541$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chowdhury, Fahima</creatorcontrib><creatorcontrib>Akter, Afroza</creatorcontrib><creatorcontrib>Bhuiyan, Taufiqur Rahman</creatorcontrib><creatorcontrib>Tauheed, Imam</creatorcontrib><creatorcontrib>Teshome, Samuel</creatorcontrib><creatorcontrib>Sil, Arijit</creatorcontrib><creatorcontrib>Park, Ju Yeon</creatorcontrib><creatorcontrib>Chon, Yun</creatorcontrib><creatorcontrib>Ferdous, Jannatul</creatorcontrib><creatorcontrib>Basher, Salima Raiyan</creatorcontrib><creatorcontrib>Ahmed, Faez</creatorcontrib><creatorcontrib>Karim, Mahbubul</creatorcontrib><creatorcontrib>Ahasan, Mohammad Mainul</creatorcontrib><creatorcontrib>Mia, Masudur Rahman</creatorcontrib><creatorcontrib>Masud, Mir Mohammad Ibna</creatorcontrib><creatorcontrib>Khan, Abdul Wahab</creatorcontrib><creatorcontrib>Billah, Masum</creatorcontrib><creatorcontrib>Nahar, Zebun</creatorcontrib><creatorcontrib>Khan, Imran</creatorcontrib><creatorcontrib>Ross, Allen G.</creatorcontrib><creatorcontrib>Kim, Deok Ryun</creatorcontrib><creatorcontrib>Ashik, Md. Muktadir Rahman</creatorcontrib><creatorcontrib>Digilio, Laura</creatorcontrib><creatorcontrib>Lynch, Julia</creatorcontrib><creatorcontrib>Excler, Jean-Louis</creatorcontrib><creatorcontrib>Clemens, John D.</creatorcontrib><creatorcontrib>Qadri, Firdausi</creatorcontrib><title>A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1–5, 6–17 and 18–45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.</description><subject>Administration, Oral</subject><subject>Adverse events</subject><subject>Age</subject><subject>Antibodies</subject><subject>Antibodies, Bacterial</subject><subject>Bangladesh - epidemiology</subject><subject>Cholera</subject><subject>Cholera - epidemiology</subject><subject>Cholera - prevention & control</subject><subject>Cholera Vaccines</subject><subject>Cholvax</subject><subject>Clinical trial</subject><subject>Clinical trials</subject><subject>Disease</subject><subject>Enrollments</subject><subject>Health care</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunogenicity</subject><subject>Infant</subject><subject>Non-inferiority</subject><subject>OCV</subject><subject>Oral vaccines</subject><subject>Pathogens</subject><subject>Pharmacists</subject><subject>Phlebotomy</subject><subject>Public private partnerships</subject><subject>Serotypes</subject><subject>Vaccines</subject><subject>Vaccines, Inactivated - adverse effects</subject><subject>Vibrio cholerae O1</subject><subject>Waterborne diseases</subject><issn>0264-410X</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkc1uEzEUhS1ERUPgEUCW2BQpM9gee2a8QiWlLVIlFoDEzrI9dxqnEzu1J2krXh6PEliwYXWlq-_-nHMQekNJSQmtP6zLvbbWeSgZYbSkrCRUPEMz2jZVwQRtn6MZYTUvOCU_T9HLlNaEEFFR-QKdVlzWUnA6Q7_OsQ--cL6H6EJ04xMeo9MDtmGz1dH5Wzw-BHznhgG6BX5YhQGwhWFY4BAnbGpEjY_PJHy2zJ29fsT7VOJvK-0n4j12Hl-s9J1e4E_a3w66g7R6hU56PSR4faxz9OPy8_fldXHz9erL8vymsJyTsTAcZM0NNbIRnej7hletBMFk23XAsiJtjawp51o0htNOGANtxUUjTQO0gWqOzg57tzHc7yCNauPSpEF7CLukWE2FZITUbUbf_YOuwy76_N1ESVHVVfZ3jsSBsjGkFKFX2-g2Oj4pStSUjlqroyFqSkdRpnI6ee7tcfvObKD7O_Unjgx8PACQ7dg7iCpZB95C5yLYUXXB_efEbxTMomg</recordid><startdate>20220128</startdate><enddate>20220128</enddate><creator>Chowdhury, Fahima</creator><creator>Akter, Afroza</creator><creator>Bhuiyan, Taufiqur Rahman</creator><creator>Tauheed, Imam</creator><creator>Teshome, Samuel</creator><creator>Sil, Arijit</creator><creator>Park, Ju Yeon</creator><creator>Chon, Yun</creator><creator>Ferdous, Jannatul</creator><creator>Basher, Salima Raiyan</creator><creator>Ahmed, Faez</creator><creator>Karim, Mahbubul</creator><creator>Ahasan, Mohammad Mainul</creator><creator>Mia, Masudur Rahman</creator><creator>Masud, Mir Mohammad Ibna</creator><creator>Khan, Abdul Wahab</creator><creator>Billah, Masum</creator><creator>Nahar, Zebun</creator><creator>Khan, Imran</creator><creator>Ross, Allen G.</creator><creator>Kim, Deok Ryun</creator><creator>Ashik, Md. 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Muktadir Rahman ; Digilio, Laura ; Lynch, Julia ; Excler, Jean-Louis ; Clemens, John D. ; Qadri, Firdausi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-b4e964b1b975d5ff74389e5298dde2531acb96144a57b41d5bbe834579b7e17e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Administration, Oral</topic><topic>Adverse events</topic><topic>Age</topic><topic>Antibodies</topic><topic>Antibodies, Bacterial</topic><topic>Bangladesh - epidemiology</topic><topic>Cholera</topic><topic>Cholera - epidemiology</topic><topic>Cholera - prevention & control</topic><topic>Cholera Vaccines</topic><topic>Cholvax</topic><topic>Clinical trial</topic><topic>Clinical trials</topic><topic>Disease</topic><topic>Enrollments</topic><topic>Health care</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunogenicity</topic><topic>Infant</topic><topic>Non-inferiority</topic><topic>OCV</topic><topic>Oral vaccines</topic><topic>Pathogens</topic><topic>Pharmacists</topic><topic>Phlebotomy</topic><topic>Public private partnerships</topic><topic>Serotypes</topic><topic>Vaccines</topic><topic>Vaccines, Inactivated - adverse effects</topic><topic>Vibrio cholerae O1</topic><topic>Waterborne diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chowdhury, Fahima</creatorcontrib><creatorcontrib>Akter, Afroza</creatorcontrib><creatorcontrib>Bhuiyan, Taufiqur Rahman</creatorcontrib><creatorcontrib>Tauheed, Imam</creatorcontrib><creatorcontrib>Teshome, Samuel</creatorcontrib><creatorcontrib>Sil, Arijit</creatorcontrib><creatorcontrib>Park, Ju Yeon</creatorcontrib><creatorcontrib>Chon, Yun</creatorcontrib><creatorcontrib>Ferdous, Jannatul</creatorcontrib><creatorcontrib>Basher, Salima Raiyan</creatorcontrib><creatorcontrib>Ahmed, Faez</creatorcontrib><creatorcontrib>Karim, Mahbubul</creatorcontrib><creatorcontrib>Ahasan, Mohammad Mainul</creatorcontrib><creatorcontrib>Mia, Masudur Rahman</creatorcontrib><creatorcontrib>Masud, Mir Mohammad Ibna</creatorcontrib><creatorcontrib>Khan, Abdul Wahab</creatorcontrib><creatorcontrib>Billah, Masum</creatorcontrib><creatorcontrib>Nahar, Zebun</creatorcontrib><creatorcontrib>Khan, Imran</creatorcontrib><creatorcontrib>Ross, Allen G.</creatorcontrib><creatorcontrib>Kim, Deok Ryun</creatorcontrib><creatorcontrib>Ashik, Md. Muktadir Rahman</creatorcontrib><creatorcontrib>Digilio, Laura</creatorcontrib><creatorcontrib>Lynch, Julia</creatorcontrib><creatorcontrib>Excler, Jean-Louis</creatorcontrib><creatorcontrib>Clemens, John D.</creatorcontrib><creatorcontrib>Qadri, Firdausi</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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 Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chowdhury, Fahima</au><au>Akter, Afroza</au><au>Bhuiyan, Taufiqur Rahman</au><au>Tauheed, Imam</au><au>Teshome, Samuel</au><au>Sil, Arijit</au><au>Park, Ju Yeon</au><au>Chon, Yun</au><au>Ferdous, Jannatul</au><au>Basher, Salima Raiyan</au><au>Ahmed, Faez</au><au>Karim, Mahbubul</au><au>Ahasan, Mohammad Mainul</au><au>Mia, Masudur Rahman</au><au>Masud, Mir Mohammad Ibna</au><au>Khan, Abdul Wahab</au><au>Billah, Masum</au><au>Nahar, Zebun</au><au>Khan, Imran</au><au>Ross, Allen G.</au><au>Kim, Deok Ryun</au><au>Ashik, Md. Muktadir Rahman</au><au>Digilio, Laura</au><au>Lynch, Julia</au><au>Excler, Jean-Louis</au><au>Clemens, John D.</au><au>Qadri, Firdausi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2022-01-28</date><risdate>2022</risdate><volume>40</volume><issue>4</issue><spage>640</spage><epage>649</epage><pages>640-649</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1–5, 6–17 and 18–45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of −10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>34969541</pmid><doi>10.1016/j.vaccine.2021.12.015</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-6394-9104</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2022-01, Vol.40 (4), p.640-649 |
| issn | 0264-410X 1873-2518 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2615920068 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Administration, Oral Adverse events Age Antibodies Antibodies, Bacterial Bangladesh - epidemiology Cholera Cholera - epidemiology Cholera - prevention & control Cholera Vaccines Cholvax Clinical trial Clinical trials Disease Enrollments Health care Humans Immunization Immunogenicity Infant Non-inferiority OCV Oral vaccines Pathogens Pharmacists Phlebotomy Public private partnerships Serotypes Vaccines Vaccines, Inactivated - adverse effects Vibrio cholerae O1 Waterborne diseases |
| title | A non-inferiority trial comparing two killed, whole cell, oral cholera vaccines (Cholvax vs. Shanchol) in Dhaka, Bangladesh |
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