Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)

Summary

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.

Timeline

Start

2017-06-12

Primary completion

2019-04-15

Completion

2019-04-15

Outcome

Missed primary endpoint

release “While not reaching our protective efficacy goal of 70%, we are pleased to see a significant protective efficacy (PE = 56%) against all severe diarrhea, regardless” scandinavianbiopharma.se ↗

Publications

• Mlangeni T, Jian C, Hakkinen HK, de Vos WM, Salonen A, Kantele A. Travel to the tropics: Impact on gut microbiota. Travel Med Infect Dis. 2025 Jul-Aug;66:102869. doi: 10.1016/j.tmaid.2025.102869. Epub 2025 May 21.
• Liu J, Jokiranta TS, Carlin N, Stroup S, Zhang J, Sjostrand B, Svennerholm A-M, Houpt ER, Kantele A. Use of a TaqMan Array Card for identification of enterotoxins and colonization factors directly from stool samples in an enterotoxigenic E. coli vaccine study. Microbiol Spectr. 2025 Mar 4;13(3):e0187024. doi: 10.1128/spectrum.01870-24. Epub 2025 Feb 11.

Drugs

Indications