Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC) (NCT03729219) | Clinical Trial Compass
CompletedPhase 2
Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)
Finland749 participantsStarted 2017-06-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female age ≥18 and ≤ 65 years
✓. General good health at the time of first vaccination
✓. Female participants of childbearing potential must not be pregnant
✓. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study
✓. Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained
✓. Availability for the study duration, including all planned follow-up visits
✓. Intake of atovaquone + proguanil (Malarone) as anti-malaria prophylax according to prescription guidelines mandatory before, during and after travel to Benin
Exclusion criteria
✕. Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study
✕
What they're measuring
1
Safety: Number of vaccine attributable adverse events
Timeframe: From first vaccination until leave for Benin, approximately 13-50 days
2
Immunogenicity: Fold change of serum titers of IgA and IgG against LTB
Timeframe: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
3
Immunogenicity: Number of subjects responding to heat-labile toxin (LTB)
Timeframe: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
4
Immunogenicity: Fold change of serum titers of Immunoglobulin A (IgA) and Immunoglobulin G (IgG) against O78 lipopolysaccharide (LPS)
Timeframe: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
5
Immunogenicity: Number of subjects responding to O78 lipopolysaccharide (LPS)
Timeframe: Change from baseline (just before first vaccination) to Visit 3 (5-6 days after second vaccination), an average of 20 days
6
Diagnostic Tools:To set the optimal threshold limits of the two quantitativePolymerase chain reaction (PCR ) procedures
Timeframe: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days
. Known or suspected history of drug, chemical or alcohol abuse, as deemed by the investigator/physician; AUDIT \> 13 points
✕. Known recent history of impaired immune function which, according to the judgement of the investigator could influence the immune response
✕. Intends to receive any other investigational vaccine during the study period, or within two weeks prior to study vaccination
✕. Intends to donate blood at any time during the study.
✕. An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases and autoimmune diseases requiring treatment
✕. Any history of psychosis or bipolar disorder or on-going significant mental disorder
✕. Regular (daily) use of laxatives or agents which lower stomach acidity (antacids, proton pump inhibitors) less than one week before visit V1