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Last update 08 May 2025

Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Peda Typh, Vi conjugate typhoid vaccine, Vi-TT

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

Typhoid Fever

Inactive Indication-

Originator Organization

Bio-Med Pvt Ltd.

Active Organization

Bio-Med Pvt Ltd.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

Clinical Trials associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

CTRI/2019/06/019639

/ Not yet recruitingPhase 4IIT

Systems Vaccinology of the Vi Conjugate Typhoid Vaccine in Infants - HIPC- Typbar

Start Date16 Jul 2019

Sponsor / Collaborator

Christian Medical College

CTRI/2010/091/003031

/ CompletedPhase 4IIT

Immunogenicity of conjugated typhoid Vi vaccine in children ? Single dose Vs Two doses

Start Date02 Jan 2011

Sponsor / Collaborator-

100 Clinical Results associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

100 Translational Medicine associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

100 Patents (Medical) associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

Literatures (Medical) associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

01 Mar 2025·eClinicalMedicine

Immunogenicity and reactogenicity of a booster dose of a typhoid conjugate vaccine (TCV) in Malawian pre-school children

Article

Author: Laurens, Matthew B ; Nampota-Nkomba, Nginache ; Lipenga, Bright ; Mapemba, Victoria ; Ndaferankhande, John M ; Neuzil, Kathleen M ; Patel, Priyanka D ; Mwakiseghile, Felistas ; Nyirenda, Osward M ; Pasetti, Marcela F ; Jamka, Leslie P ; Oshinsky, Jennifer ; Gordon, Melita A ; Misiri, Theresa ; Datta, Shrimati

BackgroundWe assessed persistence of typhoid immunity conferred by Vi polysaccharide-tetanus toxoid (Vi-TT) conjugate vaccine (TCV) four years post-vaccination and immunogenicity of a booster dose of Vi-TT given at age five.MethodsIn 2018, a phase 3 trial of Vi-TT in Malawi randomised children 1:1 to receive Vi-TT or meningococcal capsular group A conjugate vaccine (control). Subsequently, TCV was licensed and recommended in the region. In 2023, children vaccinated at 9-11 months in the original trial received a second (Booster- TCV) or first (1st-TCV) Vi-TT dose, at age five. Serum collected at days 0, 28, and 160-180 days after vaccination was tested for anti-Vi immunoglobulin (Ig)G and IgA, reported as enzyme-linked immunosorbent assay units (EU)/mL. Seroconversion was ≥4-fold rise in antibody titers from day 0 to day 28 post-vaccination. Safety outcomes included adverse events during follow-up.FindingsWe enrolled 136 children: 72 Booster-TCV and 64 1st-TCV. At baseline, anti-Vi IgG geometric mean titers (GMT) were higher in Booster-TCV (18.8 EU/mL, 95% CI 15.2-23.2) than 1st-TCV (5.7 EU/mL, 4.6-7.2) arms. GMT increased significantly between days 0 and 28 in both arms, with higher levels in Booster-TCV (6867.9 EU/mL, 5794.1-8140.6) than 1st-TCV (2912.0 EU/mL, 2429.2-3490.7) arms, representing a 375.7 and 492.6 geometric mean fold rise, respectively. On day 28, all Booster-TCV children, and all but one 1st-TCV child, seroconverted. Similar trends were seen for IgA. Vi-TT reactogenicity was similar between vaccine arms.InterpretationThis study demonstrates sustained Vi-TT immunogenicity four years post-vaccination at 9-11 months old, and robust immune response following a booster dose at five years of age, informing policy decisions on TCV use in children.FundingBill & Melinda Gates Foundation (INV-030857).

31 Dec 2024·Human Vaccines & Immunotherapeutics

Single and two-dose typhoid conjugate vaccine safety and immunogenicity in HIV-exposed uninfected and HIV-unexposed uninfected Malawian children

Article

Author: Patel, Pratiksha ; Ndaferankhande, John M. ; Nampota-Nkomba, Nginache ; Patel, Priyanka D. ; Banda, Happy ; Neuzil, Kathleen M. ; Lipenga, Bright ; Mapemba, Victoria ; Pasetti, Marcela F. ; Misiri, Theresa ; Gordon, Melita A. ; Datta, Shrimati ; Masonga, Rhoda ; Laurens, Matthew B. ; Jamka, Leslie P. ; Wachepa, Richard ; Oshinsky, Jennifer ; Hosangadi, Divya ; Mwakiseghile, Felistas ; Heyderman, Robert S. ; Nyirenda, Osward M.

Vaccine safety and immunogenicity data in human immunodeficiency virus (HIV)-exposed uninfected (HEU) children are important for decision-making in HIV and typhoid co-endemic countries. In an open-label study, we recruited Malawian HEU and HIV unexposed uninfected (HUU) infants aged 9 - 11 months. HEU participants were randomized to receive Vi-tetanus toxoid conjugate vaccine (Vi-TT) at 9 months, Vi-TT at 15 months, or Vi-TT at 9 and 15 months. HUU participants received Vi-TT at 9 and 15 months. Safety outcomes included solicited and unsolicited adverse events (AE) and serious AEs (SAEs) within 7 days, 28 days, and 6 months of vaccination, respectively. Serum was collected before and at day 28 after each vaccination to measure anti-Vi IgG antibodies by enzyme-linked immunosorbent assay (ELISA). Cohort 1 (66 participants) enrollment began 02 December 2019, and follow-up was terminated before completion due to the COVID-19 pandemic. Cohort 2 (100 participants) enrollment began 25 March 2020. Solicited AEs were mostly mild, with no significant differences between HEU and HUU participants or one- and two-dose groups. All six SAEs were unrelated to vaccination. Anti-Vi geometric mean titers (GMT) increased significantly from 4.1 to 4.6 ELISA units (EU)/mL at baseline to 2572.0 - 4117.6 EU/mL on day 28 post-vaccination, and similarly between HEU and HUU participants for both one- and two-dose schedules. All participants seroconverted (>4-fold increase in GMT) by the final study visit. Our findings of comparable safety and immunogenicity of Vi-TT in HUU and HEU children support country introductions with single-dose Vi-TT in HIV-endemic countries.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of conjugate vaccine for typhoid (Vi-DT): Finding from an observer-blind, active-controlled, randomized, non-inferiority, phase III clinical trial among healthy volunteers

Article

Author: Tamrakar, Rajendra ; Gupta, Birendra Prasad ; Khadgi, Amit ; Tamrakar, Dipesh ; Shrestha, Anmol ; Rai, Ganesh Kumar ; Saluja, Tarun ; Thapa, Pragya ; Poudel, Pranodan ; Madhup, Surendra ; Shrestha, Rajeev ; Singh, Srijana ; Sahastrabuddhe, Sushant ; Thapa, Sameera

Typhoid fever is a significant public health concern with most of the sufferers between 15 and 25 y of age in Nepal. We undertook this study to demonstrate Vi polysaccharide conjugated with diphtheria toxoid (Vi-DT) conjugate vaccine which is non-inferior to Typbar typhoid conjugate vaccine, a Vi polysaccharide vaccine conjugated with tetanus toxoid (Vi-TT) with a focus on the adult population from Dhulikhel Hospital which was one of the total four sites in Nepal. In this study, we assigned the eligible participants in 1:1:1:1 ratio by block randomization, and stratified into three age groups (6 months to less than 2 y, 2 y to less than 18 y, and 18 y to 45 y), allotted to Group A, B, C, and D. Group A, B, and C received 25 μg (0.5 mL) of Vi-DT study vaccine and participants in Group D received 25 μg (0.5 mL) Vi-TT vaccine. We descriptively analyzed safety in all the participants receiving one dose of the investigational vaccine. The anti-Vi-IgG seroconversion rate in Vi-DT recipients was 99.71% (97.5% CI 98.04-99.96; 344 of 345 participants) and 99.13% (94.27-99.87; 114 of 115) in Vi-TT recipients which indicates that Vi-DT vaccine is non-inferior to Vi-TT vaccine. In safety aspect, 16.81% of total subject had at least one solicited adverse reaction and 22.61% of the Vi-TT participants experienced at least one solicited adverse reaction with most of them being local adverse reactions. None of the enrolled participants reported serious adverse events. Our study shows that a single dose of the Vi-DT vaccine is immunogenic, safe to administer and non-inferior to the Vi-TT vaccine four weeks after vaccination.

100 Deals associated with Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

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Indication	Country/Location	Organization	Date
Typhoid Fever	India	Bio-Med Pvt Ltd.	-

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Vi conjugate typhoid vaccine(Bio-Med Pvt Ltd.)

Overview

Basic Info

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation