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
| Title: | 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 |
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| Authors: | Dipesh Tamrakar, Pranodan Poudel, Pragya Thapa, Srijana Singh, Amit Khadgi, Sameera Thapa, Rajendra Tamrakar, Anmol Shrestha, Surendra Madhup, Ganesh Kumar Rai, Birendra Prasad Gupta, Tarun Saluja, Sushant Sahastrabuddhe, Rajeev Shrestha |
| Source: | Human Vaccines & Immunotherapeutics, Vol 20, Iss 1 (2024) |
| Publisher Information: | Taylor & Francis Group, 2024. |
| Publication Year: | 2024 |
| Collection: | LCC:Immunologic diseases. Allergy LCC:Therapeutics. Pharmacology |
| Subject Terms: | Typhoid, conjugate vaccine, observer-blind, randomized, phase III clinical trial, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950 |
| More Details: | 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. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 21645515 2164-554X 2164-5515 |
| Relation: | https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X |
| DOI: | 10.1080/21645515.2023.2301631 |
| Access URL: | https://doaj.org/article/028ffd7dcc0941d38c9bd4388f3e04de |
| Accession Number: | edsdoj.028ffd7dcc0941d38c9bd4388f3e04de |
| Database: | Directory of Open Access Journals |
| ISSN: | 21645515 2164554X |
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| DOI: | 10.1080/21645515.2023.2301631 |
| Published in: | Human Vaccines & Immunotherapeutics |
| Language: | English |