Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine

Summary

This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.

Timeline

Start

2019-11-15

Primary completion

2020-09

Completion

2021-01

Outcome

Met primary endpoint

paper 0·47% (97·5% CI -0·68 to 1·61), indicating non-inferiority of the Vi-DT vaccine. PMID 34942090 ↗

paper indicating lot-to-lot equivalence according to the predefined, WHO-recommended equivalence margin. PMID 34942090 ↗

Publications

• Kumar Rai G, Saluja T, Chaudhary S, Tamrakar D, Kanodia P, Giri BR, Shrestha R, Uranw S, Kim DR, Yang JS, Park IY, Kyung SE, Vemula S, Reddy E J, Kim B, Gupta BP, Jo SK, Ryu JH, Park HK, Shin JH, Lee Y, Kim H, Kim JH, Mojares ZR, Wartel TA, Sahastrabuddhe S. Safety and immunogenicity of the Vi-DT typhoid conjugate vaccine in healthy volunteers in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial. Lancet Infect Dis. 2022 Apr;22(4):529-540. doi: 10.1016/S1473-3099(21)00455-2. Epub 2021 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Typbar-TCV	Vaccine	25 ug	Intramuscular
Comparator	Typbar-TCV	Vaccine	0.5 ml	Intramuscular
Subject	Vi-DT Typhoid conjugate vaccine	Unknown	25 ug	Intramuscular
Subject	Vi-DT Typhoid conjugate vaccine	Unknown	0.5 ml	Intramuscular

Indications