Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial

Typhoid fever is a major public health problem in low-resource settings. Vaccination can help curb the disease and might reduce transmission. We have previously reported an interim analysis of the efficacy of typhoid conjugate vaccine (TCV) in Nepali children. Here we report the final results after...

Full description

Saved in:
Bibliographic Details
Published in:The Lancet global health 2021-11, Vol.9 (11), p.e1561-e1568
Main Authors: Shakya, Mila, Voysey, Merryn, Theiss-Nyland, Katherine, Colin-Jones, Rachel, Pant, Dikshya, Adhikari, Anup, Tonks, Susan, Mujadidi, Yama F, O’Reilly, Peter, Mazur, Olga, Kelly, Sarah, Liu, Xinxue, Maharjan, Archana, Dahal, Ashata, Haque, Naheeda, Pradhan, Anisha, Shrestha, Suchita, Joshi, Manij, Smith, Nicola, Hill, Jennifer, Clarke, Jenny, Stockdale, Lisa, Jones, Elizabeth, Lubinda, Timothy, Bajracharya, Binod, Dongol, Sabina, Karkey, Abhilasha, Baker, Stephen, Dougan, Gordan, Pitzer, Virginia E, Neuzil, Kathleen M, Shrestha, Shrijana, Basnyat, Buddha, Pollard, Andrew J
Format: Article
Language:English
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3
cites cdi_FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3
container_end_page e1568
container_issue 11
container_start_page e1561
container_title The Lancet global health
container_volume 9
creator Shakya, Mila
Voysey, Merryn
Theiss-Nyland, Katherine
Colin-Jones, Rachel
Pant, Dikshya
Adhikari, Anup
Tonks, Susan
Mujadidi, Yama F
O’Reilly, Peter
Mazur, Olga
Kelly, Sarah
Liu, Xinxue
Maharjan, Archana
Dahal, Ashata
Haque, Naheeda
Pradhan, Anisha
Shrestha, Suchita
Joshi, Manij
Smith, Nicola
Hill, Jennifer
Clarke, Jenny
Stockdale, Lisa
Jones, Elizabeth
Lubinda, Timothy
Bajracharya, Binod
Dongol, Sabina
Karkey, Abhilasha
Baker, Stephen
Dougan, Gordan
Pitzer, Virginia E
Neuzil, Kathleen M
Shrestha, Shrijana
Basnyat, Buddha
Pollard, Andrew J
description Typhoid fever is a major public health problem in low-resource settings. Vaccination can help curb the disease and might reduce transmission. We have previously reported an interim analysis of the efficacy of typhoid conjugate vaccine (TCV) in Nepali children. Here we report the final results after 2 years of follow-up. We did a participant-masked and observer-masked individually randomised trial in Lalitpur, Nepal, in which 20 019 children aged 9 months to younger than 16 years were randomly assigned in a 1:1 ratio to receive a single dose of TCV (Typbar TCV, Bharat Biotech International, India) or capsular group A meningococcal conjugate vaccine (MenA). Participants were followed up until April 9, 2020. The primary outcome was blood culture-confirmed typhoid fever. Cases were captured via passive surveillance and active telephone surveillance followed by medical record review. The trial is registered at ISRCTN registry, ISRCTN43385161 and is ongoing. From Nov 20, 2017, to April 9, 2018, of 20 119 children screened, 20 019 participants were randomly assigned to receive TCV or MenA vaccine. There were 75 cases of blood culture-confirmed typhoid fever included in the analysis (13 in the TCV group and 62 in the MenA group) over the 2-year period. The protective efficacy of TCV against blood culture-confirmed typhoid fever at 2 years was 79·0% (95% CI 61·9–88·5; p
doi_str_mv 10.1016/S2214-109X(21)00346-6
format article
fullrecord <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_89d81813ca594f3a90a0367b40bb5cc3</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S2214109X21003466</els_id><doaj_id>oai_doaj_org_article_89d81813ca594f3a90a0367b40bb5cc3</doaj_id><sourcerecordid>2584802900</sourcerecordid><originalsourceid>FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3</originalsourceid><addsrcrecordid>eNqFkV9rFDEUxYMotqz9CEIeK3Q0yUwyEx8UKbUtFH1QwbeQPze7WbKTNZlZ2G9vdrcU-2ReEk7u-V3uPQi9peQ9JVR8-MEY7RpK5O9LRt8R0naiES_Q-ZP88p_3GbooZU3qkbJlff8andX6fqByOEerG--D1XaPk8fTfrtKwWGbxvW81BPgnbY2jIDDiL_BVseP2IdRR5yhzHEqB5PG25UugNsrnPXo0iYUcFcHxpRTjODwlIOOb9Arr2OBi8d7gX59vfl5fdc8fL-9v_7y0Fgu2NQ4YYi3xvc9EdxL0KQ3FAzXRNB2IMRRxlvHfMep6YTphaTMsK6TnRO-Cu0C3Z-4Lum12uaw0Xmvkg7qKKS8VDpPwUZQg3QDHWhrNZedb7UkmrSiNx0xhlvbVtanE2s7mw04C3UkHZ9Bn_-MYaWWaacGzqmo5AW6fATk9GeGMqm6HQsx6hHSXBTjQzcQJmuCC8RPpTanUjL4pzaUqEPo6hi6OiSqGFXH0JWovs8nH9Sl7gJkVWyA0YILGexUpw7_IfwFqBayeg</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2584802900</pqid></control><display><type>article</type><title>Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial</title><source>ScienceDirect Journals</source><creator>Shakya, Mila ; Voysey, Merryn ; Theiss-Nyland, Katherine ; Colin-Jones, Rachel ; Pant, Dikshya ; Adhikari, Anup ; Tonks, Susan ; Mujadidi, Yama F ; O’Reilly, Peter ; Mazur, Olga ; Kelly, Sarah ; Liu, Xinxue ; Maharjan, Archana ; Dahal, Ashata ; Haque, Naheeda ; Pradhan, Anisha ; Shrestha, Suchita ; Joshi, Manij ; Smith, Nicola ; Hill, Jennifer ; Clarke, Jenny ; Stockdale, Lisa ; Jones, Elizabeth ; Lubinda, Timothy ; Bajracharya, Binod ; Dongol, Sabina ; Karkey, Abhilasha ; Baker, Stephen ; Dougan, Gordan ; Pitzer, Virginia E ; Neuzil, Kathleen M ; Shrestha, Shrijana ; Basnyat, Buddha ; Pollard, Andrew J</creator><creatorcontrib>Shakya, Mila ; Voysey, Merryn ; Theiss-Nyland, Katherine ; Colin-Jones, Rachel ; Pant, Dikshya ; Adhikari, Anup ; Tonks, Susan ; Mujadidi, Yama F ; O’Reilly, Peter ; Mazur, Olga ; Kelly, Sarah ; Liu, Xinxue ; Maharjan, Archana ; Dahal, Ashata ; Haque, Naheeda ; Pradhan, Anisha ; Shrestha, Suchita ; Joshi, Manij ; Smith, Nicola ; Hill, Jennifer ; Clarke, Jenny ; Stockdale, Lisa ; Jones, Elizabeth ; Lubinda, Timothy ; Bajracharya, Binod ; Dongol, Sabina ; Karkey, Abhilasha ; Baker, Stephen ; Dougan, Gordan ; Pitzer, Virginia E ; Neuzil, Kathleen M ; Shrestha, Shrijana ; Basnyat, Buddha ; Pollard, Andrew J ; TyVAC Nepal Team</creatorcontrib><description>Typhoid fever is a major public health problem in low-resource settings. Vaccination can help curb the disease and might reduce transmission. We have previously reported an interim analysis of the efficacy of typhoid conjugate vaccine (TCV) in Nepali children. Here we report the final results after 2 years of follow-up. We did a participant-masked and observer-masked individually randomised trial in Lalitpur, Nepal, in which 20 019 children aged 9 months to younger than 16 years were randomly assigned in a 1:1 ratio to receive a single dose of TCV (Typbar TCV, Bharat Biotech International, India) or capsular group A meningococcal conjugate vaccine (MenA). Participants were followed up until April 9, 2020. The primary outcome was blood culture-confirmed typhoid fever. Cases were captured via passive surveillance and active telephone surveillance followed by medical record review. The trial is registered at ISRCTN registry, ISRCTN43385161 and is ongoing. From Nov 20, 2017, to April 9, 2018, of 20 119 children screened, 20 019 participants were randomly assigned to receive TCV or MenA vaccine. There were 75 cases of blood culture-confirmed typhoid fever included in the analysis (13 in the TCV group and 62 in the MenA group) over the 2-year period. The protective efficacy of TCV against blood culture-confirmed typhoid fever at 2 years was 79·0% (95% CI 61·9–88·5; p&lt;0·0001). The incidence of typhoid fever was 72 (95% CI 38–123) cases per 100 000 person-years in the TCV group and 342 (95% CI 262–438) cases per 100 000 person-years in the MenA group. Adverse events occurring within the first 7 days post-vaccination were reported previously. The final results of this randomised, controlled trial are in keeping with the results of our published interim analysis. There is no evidence of waning protection over a 2-year period. These findings add further support for the WHO recommendations on control of enteric fever. Bill &amp; Melinda Gates Foundation.</description><identifier>ISSN: 2214-109X</identifier><identifier>EISSN: 2214-109X</identifier><identifier>DOI: 10.1016/S2214-109X(21)00346-6</identifier><identifier>PMID: 34678198</identifier><language>eng</language><publisher>Elsevier Ltd</publisher><ispartof>The Lancet global health, 2021-11, Vol.9 (11), p.e1561-e1568</ispartof><rights>2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license</rights><rights>2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3</citedby><cites>FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S2214109X21003466$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,3547,27923,27924,45779</link.rule.ids></links><search><creatorcontrib>Shakya, Mila</creatorcontrib><creatorcontrib>Voysey, Merryn</creatorcontrib><creatorcontrib>Theiss-Nyland, Katherine</creatorcontrib><creatorcontrib>Colin-Jones, Rachel</creatorcontrib><creatorcontrib>Pant, Dikshya</creatorcontrib><creatorcontrib>Adhikari, Anup</creatorcontrib><creatorcontrib>Tonks, Susan</creatorcontrib><creatorcontrib>Mujadidi, Yama F</creatorcontrib><creatorcontrib>O’Reilly, Peter</creatorcontrib><creatorcontrib>Mazur, Olga</creatorcontrib><creatorcontrib>Kelly, Sarah</creatorcontrib><creatorcontrib>Liu, Xinxue</creatorcontrib><creatorcontrib>Maharjan, Archana</creatorcontrib><creatorcontrib>Dahal, Ashata</creatorcontrib><creatorcontrib>Haque, Naheeda</creatorcontrib><creatorcontrib>Pradhan, Anisha</creatorcontrib><creatorcontrib>Shrestha, Suchita</creatorcontrib><creatorcontrib>Joshi, Manij</creatorcontrib><creatorcontrib>Smith, Nicola</creatorcontrib><creatorcontrib>Hill, Jennifer</creatorcontrib><creatorcontrib>Clarke, Jenny</creatorcontrib><creatorcontrib>Stockdale, Lisa</creatorcontrib><creatorcontrib>Jones, Elizabeth</creatorcontrib><creatorcontrib>Lubinda, Timothy</creatorcontrib><creatorcontrib>Bajracharya, Binod</creatorcontrib><creatorcontrib>Dongol, Sabina</creatorcontrib><creatorcontrib>Karkey, Abhilasha</creatorcontrib><creatorcontrib>Baker, Stephen</creatorcontrib><creatorcontrib>Dougan, Gordan</creatorcontrib><creatorcontrib>Pitzer, Virginia E</creatorcontrib><creatorcontrib>Neuzil, Kathleen M</creatorcontrib><creatorcontrib>Shrestha, Shrijana</creatorcontrib><creatorcontrib>Basnyat, Buddha</creatorcontrib><creatorcontrib>Pollard, Andrew J</creatorcontrib><creatorcontrib>TyVAC Nepal Team</creatorcontrib><title>Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial</title><title>The Lancet global health</title><description>Typhoid fever is a major public health problem in low-resource settings. Vaccination can help curb the disease and might reduce transmission. We have previously reported an interim analysis of the efficacy of typhoid conjugate vaccine (TCV) in Nepali children. Here we report the final results after 2 years of follow-up. We did a participant-masked and observer-masked individually randomised trial in Lalitpur, Nepal, in which 20 019 children aged 9 months to younger than 16 years were randomly assigned in a 1:1 ratio to receive a single dose of TCV (Typbar TCV, Bharat Biotech International, India) or capsular group A meningococcal conjugate vaccine (MenA). Participants were followed up until April 9, 2020. The primary outcome was blood culture-confirmed typhoid fever. Cases were captured via passive surveillance and active telephone surveillance followed by medical record review. The trial is registered at ISRCTN registry, ISRCTN43385161 and is ongoing. From Nov 20, 2017, to April 9, 2018, of 20 119 children screened, 20 019 participants were randomly assigned to receive TCV or MenA vaccine. There were 75 cases of blood culture-confirmed typhoid fever included in the analysis (13 in the TCV group and 62 in the MenA group) over the 2-year period. The protective efficacy of TCV against blood culture-confirmed typhoid fever at 2 years was 79·0% (95% CI 61·9–88·5; p&lt;0·0001). The incidence of typhoid fever was 72 (95% CI 38–123) cases per 100 000 person-years in the TCV group and 342 (95% CI 262–438) cases per 100 000 person-years in the MenA group. Adverse events occurring within the first 7 days post-vaccination were reported previously. The final results of this randomised, controlled trial are in keeping with the results of our published interim analysis. There is no evidence of waning protection over a 2-year period. These findings add further support for the WHO recommendations on control of enteric fever. Bill &amp; Melinda Gates Foundation.</description><issn>2214-109X</issn><issn>2214-109X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNqFkV9rFDEUxYMotqz9CEIeK3Q0yUwyEx8UKbUtFH1QwbeQPze7WbKTNZlZ2G9vdrcU-2ReEk7u-V3uPQi9peQ9JVR8-MEY7RpK5O9LRt8R0naiES_Q-ZP88p_3GbooZU3qkbJlff8andX6fqByOEerG--D1XaPk8fTfrtKwWGbxvW81BPgnbY2jIDDiL_BVseP2IdRR5yhzHEqB5PG25UugNsrnPXo0iYUcFcHxpRTjODwlIOOb9Arr2OBi8d7gX59vfl5fdc8fL-9v_7y0Fgu2NQ4YYi3xvc9EdxL0KQ3FAzXRNB2IMRRxlvHfMep6YTphaTMsK6TnRO-Cu0C3Z-4Lum12uaw0Xmvkg7qKKS8VDpPwUZQg3QDHWhrNZedb7UkmrSiNx0xhlvbVtanE2s7mw04C3UkHZ9Bn_-MYaWWaacGzqmo5AW6fATk9GeGMqm6HQsx6hHSXBTjQzcQJmuCC8RPpTanUjL4pzaUqEPo6hi6OiSqGFXH0JWovs8nH9Sl7gJkVWyA0YILGexUpw7_IfwFqBayeg</recordid><startdate>20211101</startdate><enddate>20211101</enddate><creator>Shakya, Mila</creator><creator>Voysey, Merryn</creator><creator>Theiss-Nyland, Katherine</creator><creator>Colin-Jones, Rachel</creator><creator>Pant, Dikshya</creator><creator>Adhikari, Anup</creator><creator>Tonks, Susan</creator><creator>Mujadidi, Yama F</creator><creator>O’Reilly, Peter</creator><creator>Mazur, Olga</creator><creator>Kelly, Sarah</creator><creator>Liu, Xinxue</creator><creator>Maharjan, Archana</creator><creator>Dahal, Ashata</creator><creator>Haque, Naheeda</creator><creator>Pradhan, Anisha</creator><creator>Shrestha, Suchita</creator><creator>Joshi, Manij</creator><creator>Smith, Nicola</creator><creator>Hill, Jennifer</creator><creator>Clarke, Jenny</creator><creator>Stockdale, Lisa</creator><creator>Jones, Elizabeth</creator><creator>Lubinda, Timothy</creator><creator>Bajracharya, Binod</creator><creator>Dongol, Sabina</creator><creator>Karkey, Abhilasha</creator><creator>Baker, Stephen</creator><creator>Dougan, Gordan</creator><creator>Pitzer, Virginia E</creator><creator>Neuzil, Kathleen M</creator><creator>Shrestha, Shrijana</creator><creator>Basnyat, Buddha</creator><creator>Pollard, Andrew J</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20211101</creationdate><title>Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial</title><author>Shakya, Mila ; Voysey, Merryn ; Theiss-Nyland, Katherine ; Colin-Jones, Rachel ; Pant, Dikshya ; Adhikari, Anup ; Tonks, Susan ; Mujadidi, Yama F ; O’Reilly, Peter ; Mazur, Olga ; Kelly, Sarah ; Liu, Xinxue ; Maharjan, Archana ; Dahal, Ashata ; Haque, Naheeda ; Pradhan, Anisha ; Shrestha, Suchita ; Joshi, Manij ; Smith, Nicola ; Hill, Jennifer ; Clarke, Jenny ; Stockdale, Lisa ; Jones, Elizabeth ; Lubinda, Timothy ; Bajracharya, Binod ; Dongol, Sabina ; Karkey, Abhilasha ; Baker, Stephen ; Dougan, Gordan ; Pitzer, Virginia E ; Neuzil, Kathleen M ; Shrestha, Shrijana ; Basnyat, Buddha ; Pollard, Andrew J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shakya, Mila</creatorcontrib><creatorcontrib>Voysey, Merryn</creatorcontrib><creatorcontrib>Theiss-Nyland, Katherine</creatorcontrib><creatorcontrib>Colin-Jones, Rachel</creatorcontrib><creatorcontrib>Pant, Dikshya</creatorcontrib><creatorcontrib>Adhikari, Anup</creatorcontrib><creatorcontrib>Tonks, Susan</creatorcontrib><creatorcontrib>Mujadidi, Yama F</creatorcontrib><creatorcontrib>O’Reilly, Peter</creatorcontrib><creatorcontrib>Mazur, Olga</creatorcontrib><creatorcontrib>Kelly, Sarah</creatorcontrib><creatorcontrib>Liu, Xinxue</creatorcontrib><creatorcontrib>Maharjan, Archana</creatorcontrib><creatorcontrib>Dahal, Ashata</creatorcontrib><creatorcontrib>Haque, Naheeda</creatorcontrib><creatorcontrib>Pradhan, Anisha</creatorcontrib><creatorcontrib>Shrestha, Suchita</creatorcontrib><creatorcontrib>Joshi, Manij</creatorcontrib><creatorcontrib>Smith, Nicola</creatorcontrib><creatorcontrib>Hill, Jennifer</creatorcontrib><creatorcontrib>Clarke, Jenny</creatorcontrib><creatorcontrib>Stockdale, Lisa</creatorcontrib><creatorcontrib>Jones, Elizabeth</creatorcontrib><creatorcontrib>Lubinda, Timothy</creatorcontrib><creatorcontrib>Bajracharya, Binod</creatorcontrib><creatorcontrib>Dongol, Sabina</creatorcontrib><creatorcontrib>Karkey, Abhilasha</creatorcontrib><creatorcontrib>Baker, Stephen</creatorcontrib><creatorcontrib>Dougan, Gordan</creatorcontrib><creatorcontrib>Pitzer, Virginia E</creatorcontrib><creatorcontrib>Neuzil, Kathleen M</creatorcontrib><creatorcontrib>Shrestha, Shrijana</creatorcontrib><creatorcontrib>Basnyat, Buddha</creatorcontrib><creatorcontrib>Pollard, Andrew J</creatorcontrib><creatorcontrib>TyVAC Nepal Team</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>The Lancet global health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shakya, Mila</au><au>Voysey, Merryn</au><au>Theiss-Nyland, Katherine</au><au>Colin-Jones, Rachel</au><au>Pant, Dikshya</au><au>Adhikari, Anup</au><au>Tonks, Susan</au><au>Mujadidi, Yama F</au><au>O’Reilly, Peter</au><au>Mazur, Olga</au><au>Kelly, Sarah</au><au>Liu, Xinxue</au><au>Maharjan, Archana</au><au>Dahal, Ashata</au><au>Haque, Naheeda</au><au>Pradhan, Anisha</au><au>Shrestha, Suchita</au><au>Joshi, Manij</au><au>Smith, Nicola</au><au>Hill, Jennifer</au><au>Clarke, Jenny</au><au>Stockdale, Lisa</au><au>Jones, Elizabeth</au><au>Lubinda, Timothy</au><au>Bajracharya, Binod</au><au>Dongol, Sabina</au><au>Karkey, Abhilasha</au><au>Baker, Stephen</au><au>Dougan, Gordan</au><au>Pitzer, Virginia E</au><au>Neuzil, Kathleen M</au><au>Shrestha, Shrijana</au><au>Basnyat, Buddha</au><au>Pollard, Andrew J</au><aucorp>TyVAC Nepal Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial</atitle><jtitle>The Lancet global health</jtitle><date>2021-11-01</date><risdate>2021</risdate><volume>9</volume><issue>11</issue><spage>e1561</spage><epage>e1568</epage><pages>e1561-e1568</pages><issn>2214-109X</issn><eissn>2214-109X</eissn><abstract>Typhoid fever is a major public health problem in low-resource settings. Vaccination can help curb the disease and might reduce transmission. We have previously reported an interim analysis of the efficacy of typhoid conjugate vaccine (TCV) in Nepali children. Here we report the final results after 2 years of follow-up. We did a participant-masked and observer-masked individually randomised trial in Lalitpur, Nepal, in which 20 019 children aged 9 months to younger than 16 years were randomly assigned in a 1:1 ratio to receive a single dose of TCV (Typbar TCV, Bharat Biotech International, India) or capsular group A meningococcal conjugate vaccine (MenA). Participants were followed up until April 9, 2020. The primary outcome was blood culture-confirmed typhoid fever. Cases were captured via passive surveillance and active telephone surveillance followed by medical record review. The trial is registered at ISRCTN registry, ISRCTN43385161 and is ongoing. From Nov 20, 2017, to April 9, 2018, of 20 119 children screened, 20 019 participants were randomly assigned to receive TCV or MenA vaccine. There were 75 cases of blood culture-confirmed typhoid fever included in the analysis (13 in the TCV group and 62 in the MenA group) over the 2-year period. The protective efficacy of TCV against blood culture-confirmed typhoid fever at 2 years was 79·0% (95% CI 61·9–88·5; p&lt;0·0001). The incidence of typhoid fever was 72 (95% CI 38–123) cases per 100 000 person-years in the TCV group and 342 (95% CI 262–438) cases per 100 000 person-years in the MenA group. Adverse events occurring within the first 7 days post-vaccination were reported previously. The final results of this randomised, controlled trial are in keeping with the results of our published interim analysis. There is no evidence of waning protection over a 2-year period. These findings add further support for the WHO recommendations on control of enteric fever. Bill &amp; Melinda Gates Foundation.</abstract><pub>Elsevier Ltd</pub><pmid>34678198</pmid><doi>10.1016/S2214-109X(21)00346-6</doi><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 2214-109X
ispartof The Lancet global health, 2021-11, Vol.9 (11), p.e1561-e1568
issn 2214-109X
2214-109X
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_89d81813ca594f3a90a0367b40bb5cc3
source ScienceDirect Journals
title Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-11T17%3A52%3A19IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20of%20typhoid%20conjugate%20vaccine%20in%20Nepal:%20final%20results%20of%20a%20phase%203,%20randomised,%20controlled%20trial&rft.jtitle=The%20Lancet%20global%20health&rft.au=Shakya,%20Mila&rft.aucorp=TyVAC%20Nepal%20Team&rft.date=2021-11-01&rft.volume=9&rft.issue=11&rft.spage=e1561&rft.epage=e1568&rft.pages=e1561-e1568&rft.issn=2214-109X&rft.eissn=2214-109X&rft_id=info:doi/10.1016/S2214-109X(21)00346-6&rft_dat=%3Cproquest_doaj_%3E2584802900%3C/proquest_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c562t-d6b0fcbf77065f9ea07b1eb5a0613800d1253d2f451b46b76912b24494d6f46b3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2584802900&rft_id=info:pmid/34678198&rfr_iscdi=true