Diarrhea, Infantile Clinical Trial
Official title:
Developing A Human Challenge Model For Evaluating Vaccines Against ST-producing Enterotoxigenic Escherichia Coli
Heat stable toxin (ST) producing ETEC strains are important causes of childhood diarrhea in
many countries. Vaccine candidates targeting ST are in development. A human challenge model
using an epidemiologically relevant enterotoxigenic E.coli (ETEC) strain expressing ST, but
not other diarrhea inducing toxins like heat labile toxin (LT), is necessary to perform an
early and efficient evaluation of an ST-toxoid based vaccine.
In this controlled human infection study the investigators will assess the safety of a
ST-only producing ETEC strain and the dose needed to achieve an attack rate of 70% in healthy
human volunteers.
The investigators have evaluated the ST-only ETEC strain TW10722 in volunteers previously,
and will also evaluate the ETEC strain TW11681, an ETEC family 8, serotype O19:H45,
expressing STh, CFA/I, and CS21. These strains have been selected because it is a good
representative of one of the most important ETEC families commonly associated with childhood
ETEC diarrhea. The TW10722 will also be evaluated at higher dose if TW11681 does not work
well.
After screening including routine blood sampling, intestinal lavage and pre-challenge
sampling will be done. Volunteers will then be admitted three at a time to Haukeland
University Hospital and isolated before receiving the oral bacterial inoculum doses, starting
with 10^6 and increasing one log per round until a safe dose that elicits diarrhoea is found.
Fine adjustment of the dose needed for a diarrhea attack rate of 70% will then be done in the
remaining volunteers. Volunteers will be monitored for a range of symptoms, stool output and
adverse events.
Antibiotic treatment will be administered at certain predetermined severities of diarrheal
disease, or after 5 days to eradicate the ETEC infection in all volunteers before leaving the
hospital. Volunteers will be monitored and sampled again at day 10, 28 and 365 after
infection. Serum, plasma, stool, intestinal lavage and PBMC samples will be obtained before,
during and after the ETEC infection to evaluate immune responses and potential correlates of
protection.
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