Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine

Summary

This is a randomized, placebo-controlled dose-escalation study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.

Timeline

Start

2019-10-28

Primary completion

2021-05-07

Completion

2021-05-07

Outcome

Met primary endpoint

paper TSCV was safe and well tolerated, meeting the prespecified safety endpoints PMID 41062830 ↗

paper For each of the three polysaccharides, immune responses, as demonstrated by ≥4-fold increases over baseline, were observed among all (100%) vaccinees PMID 41062830 ↗

paper meeting the prespecified immunogenicity endpoints PMID 41062830 ↗

Publications

• Chen WH, Barnes RS, Sikorski MJ, Datar R, Sukhavasi R, Liang Y, Rapaka RR, Pasetti MF, Sztein MB, Wahid R, Tennant SM, Simon R, Baliban SM, Galen JE, Lees A, Bernshtein B, Alter G, Ella R, Mohan K, Naidu MG, Rao DY, Ella KM, Levine MM. A combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine in healthy adults: a randomized, placebo-controlled phase 1 trial. Nat Med. 2025 Dec;31(12):4256-4264. doi: 10.1038/s41591-025-04003-z. Epub 2025 Oct 8.
• Chen WH, Barnes RS, Sikorski MJ, Datar R, Sukhavasi R, Liang Y, Rapaka RR, Pasetti MF, Sztein MB, Wahid R, Tennant SM, Simon R, Baliban SM, Galen JE, Lees A, Bernshtein B, Alter G, Ella R, Mohan K, Naidu MG, Rao DY, Ella KM, Levine MM. A phase 1 randomized, placebo-controlled trial of a combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine. medRxiv [Preprint]. 2025 Sep 18:2025.09.15.25335795. doi: 10.1101/2025.09.15.25335795.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trivalent Salmonella Conjugate Vaccine	Vaccine	6.25 ug	Intramuscular
Subject	Trivalent Salmonella Conjugate Vaccine	Vaccine	12 ug	Intramuscular
Subject	Trivalent Salmonella Conjugate Vaccine	Vaccine	25 ug	Intramuscular

Indications

No indication recorded.