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Homogeneous Glycoconjugate Produced by Combined Unnatural Amino Acid Incorporation and Click-Chemistry for Vaccine Purposes
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A combination typhoid and non-typhoidal Salmonella polysaccharide conjugate vaccine in healthy adults: a randomized,

Wilbur H Chen1, Robin S Barnes2, Michael J Sikorski2

  • 1Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA. wilbur.chen@som.umaryland.edu.

Nature Medicine
|October 8, 2025
PubMed

Insights

A new Trivalent Salmonella conjugate vaccine (TSCV) is safe and effective in adults. The vaccine successfully generated immune responses against key Salmonella components, supporting further trials for invasive Salmonella disease prevention.

Area of Science:

  • Vaccinology
  • Infectious Diseases
  • Clinical Trials

Background:

  • Salmonella infections, including typhoidal and non-typhoidal Salmonella (NTS), are a major cause of invasive disease in young children in sub-Saharan Africa.
  • Current prevention strategies are limited, highlighting the need for effective vaccines.

Purpose of the Study:

  • To evaluate the safety and immunogenicity of the Trivalent Salmonella conjugate vaccine (TSCV) in a first-in-human clinical trial.
  • To assess the immune response against vaccine components, including polysaccharides and flagellin carrier proteins.

Main Methods:

  • A randomized, placebo-controlled, phase 1 trial involving 22 healthy adults aged 18-45 years.
  • Participants received either 6.25-µg TSCV, 12.5-µg TSCV, or a placebo.
  • Safety was assessed through solicited adverse events, and immunogenicity was measured by serum IgG responses.

Main Results:

  • TSCV was found to be safe and well-tolerated, with injection site pain being the most common side effect.
  • All vaccine recipients (100%) showed significant immune responses (≥4-fold increase) to the three vaccine polysaccharides.
  • Flagellin components elicited strong immune responses in 88-100% of vaccine recipients.

Conclusions:

  • The Trivalent Salmonella conjugate vaccine (TSCV) demonstrates a favorable safety profile and robust immunogenicity in adults.
  • These findings support further investigation of TSCV for the prevention of invasive Salmonella disease, particularly in at-risk populations.
  • The study met its primary safety and co-primary immunogenicity endpoints, paving the way for future efficacy trials.

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