An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants
Typhoid fever remains a significant public health concern in endemic regions, with increasing antimicrobial resistance heightening the need for preventive strategies such as vaccination. Zyvac-TCV, a typhoid conjugate vaccine developed by Zydus Lifesciences Ltd. is licensed for use across all age gr...
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2550085 |
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| author | Sanjay Vasant Mankar Chintan Patel Abhishek Chavan Ravi Modi Lisa Sarangi Virendra Nath Tripathi Dillip Kumar Dash Jai Prakash Narayan Sunil Bandgar N. Ravi Kumar Vinay Kumar Gill Munish Kumar Kakkar Monjori Mitra Pavankumar Daultani Ravindra Mittal Kapil Maithal Kevinkumar Kansagra Deven V. Parmar Trayambak Dutta Manish Mahajan Samir Desai |
| author_facet | Sanjay Vasant Mankar Chintan Patel Abhishek Chavan Ravi Modi Lisa Sarangi Virendra Nath Tripathi Dillip Kumar Dash Jai Prakash Narayan Sunil Bandgar N. Ravi Kumar Vinay Kumar Gill Munish Kumar Kakkar Monjori Mitra Pavankumar Daultani Ravindra Mittal Kapil Maithal Kevinkumar Kansagra Deven V. Parmar Trayambak Dutta Manish Mahajan Samir Desai |
| author_sort | Sanjay Vasant Mankar |
| collection | DOAJ |
| description | Typhoid fever remains a significant public health concern in endemic regions, with increasing antimicrobial resistance heightening the need for preventive strategies such as vaccination. Zyvac-TCV, a typhoid conjugate vaccine developed by Zydus Lifesciences Ltd. is licensed for use across all age groups. This prospective, multicenter, single-arm post-marketing surveillance study evaluated the safety and immunogenicity of Zyvac TCV in 3037 healthy participants aged 6 months to 45 years, enrolled across multiple Indian centers. Each participant received a single 0.5 mL intramuscular dose. Safety was assessed through monitoring of adverse events (AEs) over a 6-month period, while immunogenicity was evaluated in a subset of 300 participants by measuring serum anti-Vi IgG antibody titers at baseline and Day 28 post-vaccination. Overall, 16.7% of participants reported AEs, predominantly mild or moderate in nature, with no serious adverse events. Immunogenicity results demonstrated a seroconversion rate of 94.7% and a significant increase in geometric mean titers from 4.5 U/mL at baseline to 1787.8 U/mL at Day 28. A post-hoc batch analysis showed consistent immunogenicity across three commercial vaccine batches. Zyvac TCV was well tolerated and elicited a strong immune response in all age groups, supporting its integration into national immunization programs in typhoid-endemic regions. |
| format | Article |
| id | doaj-art-0f65a0e5a2e64c6db935f3ec11a28c38 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-0f65a0e5a2e64c6db935f3ec11a28c382025-08-26T07:55:20ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2550085An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participantsSanjay Vasant Mankar0Chintan Patel1Abhishek Chavan2Ravi Modi3Lisa Sarangi4Virendra Nath Tripathi5Dillip Kumar Dash6Jai Prakash Narayan7Sunil Bandgar8N. Ravi Kumar9Vinay Kumar Gill10Munish Kumar Kakkar11Monjori Mitra12Pavankumar Daultani13Ravindra Mittal14Kapil Maithal15Kevinkumar Kansagra16Deven V. Parmar17Trayambak Dutta18Manish Mahajan19Samir Desai20Department of Pediatrics, Mankar Hospital, Pune, IndiaDepartment of Endocrinology, Aatman Hospital, Ahmedabad, IndiaDepartment of Pediatrics, Jeevan Rekha Hospital, Belagavi, IndiaDepartment of Pediatrics, Shivnath Children Hospital, Vadodara, IndiaDepartment of Community Medicine, Hi-Tech Medical College & Hospital, Bhubaneswar, Odisha, IndiaPrakhar Hospital Pvt. Ltd., Kanpur, IndiaDepartment of Pediatrics, Institute of Medical Sciences & SUM Hospital, Bhubaneswar, IndiaDepartment of Pediatrics, Jawahar Lal Nehru Medical College & Hospital, Ajmer, IndiaPulse Multispeciality Hospital, Pune, IndiaDepartment of Pediatrics, Niloufer Hospital, Hyderabad, IndiaMaharaja Agrasen Superspeciality Hospital, Jaipur, IndiaDepartment of Pediatrics, Mahatma Gandhi Medical College and Hospital, Jaipur, IndiaDepartment of Pediatrics, Institute of Child Health, Kolkata, IndiaNew Product Development, Zydus Lifesciences Ltd, Ahmedabad, Gujarat, IndiaNew Product Development, Zydus Lifesciences Ltd, Ahmedabad, Gujarat, IndiaVaccine Technology Centre, Zydus Lifesciences Ltd., Ahmedabad, Gujarat, IndiaClinical R&D, Zydus Lifesciences Ltd., Ahmedabad, IndiaClinical R&D, Zydus Lifesciences Ltd., Ahmedabad, IndiaMedical Affairs, Zydus Lifesciences Ltd., Ahmedabad, IndiaMedical Affairs, Zydus Lifesciences Ltd., Ahmedabad, IndiaBU Biologics & Vaccines, Zydus Lifesciences Ltd., Ahmedabad, IndiaTyphoid fever remains a significant public health concern in endemic regions, with increasing antimicrobial resistance heightening the need for preventive strategies such as vaccination. Zyvac-TCV, a typhoid conjugate vaccine developed by Zydus Lifesciences Ltd. is licensed for use across all age groups. This prospective, multicenter, single-arm post-marketing surveillance study evaluated the safety and immunogenicity of Zyvac TCV in 3037 healthy participants aged 6 months to 45 years, enrolled across multiple Indian centers. Each participant received a single 0.5 mL intramuscular dose. Safety was assessed through monitoring of adverse events (AEs) over a 6-month period, while immunogenicity was evaluated in a subset of 300 participants by measuring serum anti-Vi IgG antibody titers at baseline and Day 28 post-vaccination. Overall, 16.7% of participants reported AEs, predominantly mild or moderate in nature, with no serious adverse events. Immunogenicity results demonstrated a seroconversion rate of 94.7% and a significant increase in geometric mean titers from 4.5 U/mL at baseline to 1787.8 U/mL at Day 28. A post-hoc batch analysis showed consistent immunogenicity across three commercial vaccine batches. Zyvac TCV was well tolerated and elicited a strong immune response in all age groups, supporting its integration into national immunization programs in typhoid-endemic regions.https://www.tandfonline.com/doi/10.1080/21645515.2025.2550085Typhoid conjugate vaccine (TCV)anti-Vi IgG seroconversiongeometric mean titers (GMTs)immunogenicitypost-marketing surveillance |
| spellingShingle | Sanjay Vasant Mankar Chintan Patel Abhishek Chavan Ravi Modi Lisa Sarangi Virendra Nath Tripathi Dillip Kumar Dash Jai Prakash Narayan Sunil Bandgar N. Ravi Kumar Vinay Kumar Gill Munish Kumar Kakkar Monjori Mitra Pavankumar Daultani Ravindra Mittal Kapil Maithal Kevinkumar Kansagra Deven V. Parmar Trayambak Dutta Manish Mahajan Samir Desai An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants Human Vaccines & Immunotherapeutics Typhoid conjugate vaccine (TCV) anti-Vi IgG seroconversion geometric mean titers (GMTs) immunogenicity post-marketing surveillance |
| title | An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants |
| title_full | An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants |
| title_fullStr | An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants |
| title_full_unstemmed | An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants |
| title_short | An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants |
| title_sort | active post marketing surveillance study to evaluate the safety and immunogenicity of zyvac tcv in healthy participants |
| topic | Typhoid conjugate vaccine (TCV) anti-Vi IgG seroconversion geometric mean titers (GMTs) immunogenicity post-marketing surveillance |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2550085 |
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