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 ; Singh, Srijana ; Shrestha, Rajeev ; 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.

01 Feb 2023·Vaccine

Comparative frequency of specified adverse events following Vero cell culture-derived Japanese encephalitis and Vi capsular polysaccharide typhoid vaccines in U.S. military personnel, July 2011–August 2019

Article

Author: Hills, Susan L ; Seshadri, Srihari ; Martin, Stacey W ; Collins, Limone C

Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and neurologic adverse events (AE). Studies and AE surveillance have supported JE-VC's safety, but one evaluation among military personnel found elevated hypersensitivity and neurologic AE rates. However, co-administration of multiple vaccines to some personnel might have affected results. We retrospectively compared rates of hypersensitivity and neurologic AEs within 28 days following vaccination of military personnel with JE-VC or parenteral Vi capsular polysaccharide typhoid vaccine administered without other vaccines from July 1, 2011, through August 31, 2019. Rates of most events were similar between the vaccines. Only delayed hypersensitivity reactions occurred more frequently following JE-VC (rate ratio: 4.2, 95 % CI 1.2-15.3; p = 0.03), but rates were low for both vaccines. These results support JE-VC's safety.

01 Feb 2011·Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi

[Design of field studies on vaccines which involves capturing indirect effect].

Article

Author: Huang, Zheng-qiang ; Chen, Kun ; Pan, Jin-ren

For most variety of vaccines, two types of effects-direct and indirect, can result from immunization programs. Unimmunized individuals in the population that receive immunization program can benefit from the vaccines in addition to the protection from immunization. The classical vaccine trails allocate individuals into study and control arms with individual randomization, so the programs' cost-benefit is underestimated due to the impossible measurement on indirect effect. The objectives of the present work are to introduce the conceptual framework, developed by Halloran et al, for four types of study designs that differentiate and account for direct, indirect, total and overall effects of intervention programs, and to explain the relationships of these effects as well. With the examples of field trails of oral cholera vaccines in Bangladesh and Vi typhoid vaccine in India, further issues refer to the identification of indirect effect. The application in practice is also discussed.

100 Deals associated with Vi polysaccharide typhoid vaccine(Chengdu Institute of Biological Products)

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KEGG	Wiki	ATC	Drug Bank
-	-	J07AP03	-

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Indication	Country/Location	Organization	Date
Typhoid Fever	CN	Chengdu Institute of Biological Products	31 Dec 1996

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Vi polysaccharide typhoid vaccine(Chengdu Institute of Biological Products)

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