Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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 two doses of ETVAX. Study participants will be recruited among students, and
      personnel at the University of Helsinki and Helsinki University Hospital and among those
      responding to recruitment advertisements. To be eligible, the participants have to commit
      themselves to comply with the study protocol which involves in addition to vaccination, study
      visits and sampling, and commitment to travel to Grand Popo, Benin and stay there for 12
      days. After providing written informed consent, eligible participants will be randomized
      (ratio 1:1, and block randomization in groups of 6) and immunized with two doses of vaccine
      or placebo, given 14±7 days apart while in Finland. The last dose of vaccine will be
      administered at least one week before departure (and no more than 30 days prior to travel) to
      Benin. Eligible participants will pay four pre-travel visits (V0 + V 1-3) to Aava Travel
      Clinic / University of Helsinki prior to travel. They will be asked to fill in pre-travel
      questionnaire latest at visit 1 (Q1) and fill in an Adverse Event Form (AEF1 and AEF2) after
      each dose, and give blood and fecal samples and saliva before travel. The participants will
      go together to Benin in groups of 25-35 individuals at a time.

      In Benin, the participants will be seen within 48 hours of arrival to the study site in Grand
      Popo. Once the participants arrive at the study site in Grand Popo, they will be provided
      with practical information and contact details of the study personnel. They will receive the
      health card (HC1) and a stool collection kit with instructions.

      Diarrhea reporting, stool collection, and stool submission procedures will be reviewed with
      the study participants. One routine visit at day 4 is planned for review of the participant's
      health status and collection of a routine stool sample. Other visits will take place when and
      if the participant gets Travelers Diarrhea (TD) episodes for collection of study specific
      stool samples and health related information and assessments. If more than one diarrhea
      episode occurs, 48 diarrhea and symptom (TD defined symptoms) free hours must have passed
      between the episodes for the new episode to be counted as a separate one. One or two days
      prior to departure from the Grand Popo site, all participants will have a final review of
      their HC1s. Health Card ( HC2) will be given. After 1-6 days back in Finland the participant
      has to give blood and a routine stool sample and they fill in Questionnaire 2 (Q2), HC2 will
      be reviewed. Approx. 30 days after return to Finland the last stool and blood sample will be
      collected and the post-travel questionnaire (Q3) filled and HC2 reviewed. Participants who
      get urinary tract infection will fill in Urinary questionnaire 4 (QU4) form at the time of
      infection. This follow-up is valid until V5.
    

Intervention name(s): E. coli ETVAX; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.; Oral suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, placebo-controlled phase IIb
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention