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 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.

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Publication Details

Journal
Human Vaccines & Immunotherapeutics
Published
2025-08-26
DOI
https://doi.org/10.1080/21645515.2025.2550085
Primary Topic
Salmonella and Campylobacter epidemiology
Type
article
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article

An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants

Monjori Mitra, Kapil Maithal, Ravindra Mittal, Dhruvanshu Parmar et al.
Human Vaccines & Immunotherapeutics
Salmonella and Campylobacter epidemiology
article

An active post-marketing surveillance study to evaluate the safety and immunogenicity of Zyvac TCV in healthy participants

Monjori Mitra, Kapil Maithal, Ravindra Mittal, Dhruvanshu Parmar, Chintan Patel, Trayambak Dutta, Abhishek Chavan, Dillip Kumar Dash, Sunil Bandgar, Samir Desai, Lisa Sarangi, Manish Mahajan, Sanjay Mankar, Reshma Modi, Pavankumar Daultani, Kevinkumar Kansagra, Jai Prakash Narayan, Nakka Ravi Kumar, Munish Kakkar, Virendra Nath Tripathi, V J Gill
article en

Abstract

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.

Human Vaccines & ImmunotherapeuticsVol. 21(1)
Gandhi Medical College & Hospital (IN), Niloufer Hospital (IN), Ahmedabad Civil Hospital (IN), Midas Multispeciality Hospital (IN), Jawaharlal Nehru Medical College (IN), Indian Institute of Information Technology Vadodara (IN), Jawaharlal Nehru Medical College (IN), Deenanath Mangeshkar Hospital and Research Center (IN), Bel-Rea Institute (US), Zydus Lifesciences Limited (India) (IN), Institute of Medical Sciences and Sum Hospital (IN), Institute of Child Health (IN), Hi-Tech Medical College & Hospital (IN), Chandra Shekhar Azad University of Agriculture and Technology (IN), Nethradhama Superspeciality Eye Hospital (IN), Mannar Hospital (LK), Shizuoka Children's Hospital (JP), Hospital of Prato (IT)
Openalex Percentile: Top 73%
Salmonella and Campylobacter epidemiology
DOIOpen Access PDFOpenAlex
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