Vaccine using tiny bacterial outer membrane particles to protect children from E. coli diarrhea

Development of an ETEC multivalent subunit vaccine using outer membrane vesicles

['FUNDING_R21'] · TULANE UNIVERSITY OF LOUISIANA · NIH-11291874

A new multivalent vaccine aims to protect young children from enterotoxigenic E. coli (ETEC) diarrhea by generating antibodies in the gut that block toxins and bacterial attachment.

Quick facts

Phase['FUNDING_R21']
Study typeNih_funding
SexAll
SponsorTULANE UNIVERSITY OF LOUISIANA (nih funded)
Locations1 site (NEW ORLEANS, UNITED STATES)
Trial IDNIH-11291874 on ClinicalTrials.gov

What this research studies

This project is developing a multivalent vaccine that uses outer membrane vesicles (OMVs) to deliver toxoid and colonization-factor components so the immune system makes protective gut antibodies. The team will combine antigens that target the heat-stable (ST) and heat-labile (LT) toxins plus colonization factors to broaden protection. Early lab and preclinical work will test whether immunization with OMV-adjuvanted antigens produces antibodies that neutralize toxins and prevent bacterial attachment to the intestine. If promising, the approach could move toward human testing focused on children in low-resource settings who suffer the most severe ETEC diarrhea.

Who could benefit from this research

Good fit: The eventual target population would be young children, especially those under five years old in low-resource settings who are at high risk for ETEC diarrhea.

Not a fit: People with diarrheal illness caused by other pathogens or individuals with certain severe immune deficiencies may not benefit from this vaccine approach.

Why it matters

Potential benefit: If successful, this vaccine could reduce severe, toxin-driven diarrheal illness in young children and lower hospitalizations and deaths from ETEC.

How similar studies have performed: Previous ETEC vaccine work targeting colonization factors and LT showed some promise, but broad protection including ST is an unmet need and OMV-based multivalent vaccines are a newer strategy.

Where this research is happening

NEW ORLEANS, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.

View on NIH RePORTER →

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.