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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. Presence of a significant medical or psychiatric condition, which in the opinion of the investigator precludes participation in the study
. 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
Timeframe: 12 days in Benin and 30 days post-travel in Finland, approximately 42 days