The need &amp; the issues related to new-generation typhoid conjugate vaccines in India

Vashishtha, Vipin M; Kalra, Ajay

doi:10.4103/ijmr.ijmr_1890_17

Cited by 15 publications

(19 citation statements)

References 53 publications

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“…Among new-generation vaccines against typhoid, ViPS-protein conjugate vaccines have been most promising, owing to their ability to elicit robust immune responses in infants and young children and their capacity to elicit T-cell-mediated immune memory responses, offering the potential for long-term protection. 10 …”

Section: Introductionmentioning

confidence: 99%

“…8,9 Among new-generation vaccines against typhoid, ViPSprotein conjugate vaccines have been most promising, owing to their ability to elicit robust immune responses in infants and young children and their capacity to elicit T-cell-mediated immune memory responses, offering the potential for long-term protection. 10 One such vaccine, consisting of ViPS conjugated to tetanus toxoid (Vi-TT; Typbar TCV, Bharat Biotech International, Hyderabad, India), has been licensed as a single-dose vaccine for people younger than 12 months in multiple countries (India, Nepal, Cambodia, and Nigeria), 11 and has been prequalified by WHO for purchase by UN agencies. 12 The WHO Strategic Advisory Group of Experts on Immunization has recommended that, for programmatic and epi demio logical reasons, the vaccine should be started at 9 months of age, coincident with the 9 month Expanded Programme on Immunization visit in many countries.…”

Section: Introductionmentioning

confidence: 99%

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Protection by vaccination of children against typhoid fever with a Vi-tetanus toxoid conjugate vaccine in urban Bangladesh: a cluster-randomised trial

et al. 2021

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Summary Background Typhoid fever remains a major cause of morbidity and mortality in low-income and middle-income countries. Vi-tetanus toxoid conjugate vaccine (Vi-TT) is recommended by WHO for implementation in high-burden countries, but there is little evidence about its ability to protect against clinical typhoid in such settings. Methods We did a participant-masked and observer-masked cluster-randomised trial preceded by a safety pilot phase in an urban endemic setting in Dhaka, Bangladesh. 150 clusters, each with approximately 1350 residents, were randomly assigned (1:1) to either Vi-TT or SA 14-14-2 Japanese encephalitis (JE) vaccine. Children aged 9 months to less than 16 years were invited via parent or guardian to receive a single, parenteral dose of vaccine according to their cluster of residence. The study population was followed for an average of 17·1 months. Total and overall protection by Vi-TT against blood culture-confirmed typhoid were the primary endpoints assessed in the intention-to-treat population of vaccinees or all residents in the clusters. A subset of approximately 4800 participants was assessed with active surveillance for adverse events. The trial is registered at www.isrctn.com , ISRCTN11643110. Findings 41 344 children were vaccinated in April–May, 2018, with another 20 412 children vaccinated at catch-up vaccination campaigns between September and December, 2018, and April and May, 2019. The incidence of typhoid fever (cases per 100 000 person-years) was 635 in JE vaccinees and 96 in Vi-TT vaccinees (total Vi-TT protection 85%; 97·5% CI 76 to 91, p<0·0001). Total vaccine protection was consistent in different age groups, including children vaccinated at ages under 2 years (81%; 95% CI 39 to 94, p=0·0052). The incidence was 213 among all residents in the JE clusters and 93 in the Vi-TT clusters (overall Vi-TT protection 57%; 97·5% CI 43 to 68, p<0·0001). We did not observe significant indirect vaccine protection by Vi-TT (19%; 95% CI −12 to 41, p=0·20). The vaccines were well tolerated, and no serious adverse events judged to be vaccine-related were observed. Interpretation Vi-TT provided protection against typhoid fever to children vaccinated between 9 months and less than 16 years. Longer-term follow-up will be needed to assess the duration of protection and the need for booster doses. Funding The study was funded by the Bill & Melinda Gates Foundation.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Protection by vaccination of children against typhoid fever with a Vi-tetanus toxoid conjugate vaccine in urban Bangladesh: a cluster-randomised trial

et al. 2021

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“…The new generation vaccine, typhoid conjugate vaccines (Typbar-TCV™), exhibited significant impacts on typhoid endemic areas. However, despite the presence of a new vaccine (Typbar-TCV™), we should remain vigilant and continue to evaluate the most effective antimicrobial treatments (Vashishtha and Kalra, 2020).…”

Section: Typhoid Vaccinationmentioning

confidence: 99%

Irrational use of azithromycin in typhoid endemic areas: A challenge on multidrug-resistant typhoid treatment

Ullah

Khan

Mehmood

et al. 2021

Trends Infect Global Health

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Typhoid is a food-borne fatal disease caused by Salmonella typhi. It causes inflammation of the intestine, resulting in diarrhoea, fever, headache, cough, and muscle pain. Improved hygiene has resulted in a marked decline in typhoid fever cases in many developed countries. However, significant typhoid cases emerge in low and middle-income countries annually, including Pakistan. Typhoid fever accounts for a larger percentage of acute febrile illnesses in Pakistan. Azithromycin is the only effective drug used in multidrug-resistant typhoid. The emergence of drug resistance typhoid has been of more significant concern in recent years due to its irrational use of azithromycin. It is considered the last antibiotic to eradicate multidrug-resistant typhoid fever from Pakistan. In this article, we express our concern of the irrational use of azithromycin in Pakistan and its effect on typhoid in the country.

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“…TCV is recommended to be administered as a .5 mL single dose intramuscularly for infants and children from 6 months of age and in adults up to 45 years in typhoid endemic regions. 24 Peda-Typh™ and Typbar-TCV are reported to provide protection anywhere between 2 and 5 years respectively 26 , 27 …”

Section: Introductionmentioning

confidence: 99%

“…The conjugate Vi vaccine, where the Vi-PS is covalently linked to a carrier protein, is safe and immunogenic in infants and younger children and induces protective antiVi antibodies, stimulates memory cells, and produces an immune response. 26 , 28 An injectable subunit Vi-capsular polysaccharide vaccine is a second-generation typhoid vaccine. 28 Vi—CRM 197 conjugate vaccine contains the Vi—CRM 197 conjugate in which Vi-PS from Citrobacter freundii WR7011 is conjugated to CRM 197 , a nontoxic mutant of diphtheria toxoid.…”

Section: Introductionmentioning

confidence: 99%

A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E’s Vi-capsular polysaccharide-CRM ₁₉₇ conjugate typhoid vaccine (TyphiBEV ^TM ) in healthy infants, children, and adults in comparison with a licensed comparator

Thuluva

Paradkar

Matur

et al. 2022

Human Vaccines & Immunotherapeutics

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The current scenario of typhoid fever warrants early prevention with typhoid conjugate vaccines in susceptible populations to provide lifelong protection. We conducted a multicenter, single-blind, randomized, Phase 2/3 study to assess the immunogenicity and safety of Biological E’s Typhoid Vi-CRM 197 conjugate vaccine (TyphiBEV TM ) compared to Vi-TT conjugate vaccine manufactured by Bharat Biotech International Limited (Typbar-TCV; licensed comparator) in healthy infants, children, and adults from India. The study’s primary objective was to assess the non-inferiority of TyphiBEV TM in terms of the difference in the proportion of subjects seroconverted with a seroconversion threshold value of ≥2.0 µg/mL against Typbar-TCV. A total of 622 healthy subjects (311 each in both vaccine groups) were randomized and received the single dose of the study vaccine. The TyphiBEV TM group demonstrated noninferiority compared to the Typbar-TCV group at Day 42. The lower 2-sided 95% confidence interval limit of the group difference was −.34%, which met the non-inferiority criteria of ≥10.0%. The geometric mean concentration (24.79 µg/mL vs. 26.58 µg/mL) and proportion of subjects who achieved ≥4-fold increase in antiVi IgG antibody concentrations (96.95% vs. 97.64%) at Day 42 were comparable between the TyphiBEV TM and Typbar-TCV vaccine groups. No apparent difference was observed in the safety profile between both vaccine groups. All adverse events reported were mild or moderate in intensity in all age subsets. This data demonstrates that TyphiBEV TM is non-inferior to TypbarTCV in terms of immunogenicity, and the overall safety and reactogenicity in healthy infants, children, and adults studied from India was comparable.

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The need & the issues related to new-generation typhoid conjugate vaccines in India

Cited by 15 publications

References 53 publications

Protection by vaccination of children against typhoid fever with a Vi-tetanus toxoid conjugate vaccine in urban Bangladesh: a cluster-randomised trial

Protection by vaccination of children against typhoid fever with a Vi-tetanus toxoid conjugate vaccine in urban Bangladesh: a cluster-randomised trial

Irrational use of azithromycin in typhoid endemic areas: A challenge on multidrug-resistant typhoid treatment

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