| Eligibility |
Inclusion Criteria:
- Male or female aged 18-50 years, inclusive at the time of signing the informed
consent.
- Healthy constitution as established by medical history and physical examination.
- Willing and able to give written informed consent for participation in the study.
- Able to comply with study activities, as judged by the Investigator.
- Female Participants:
- Women of child-bearing potential (for definition see Section 9.3.6 in the protocol):
- Have to agree to use an acceptable birth control method during participation in the
investigation (see Section 9.3.6).
- A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine)
at Visit 2/Day 1 will be required.
- Male Participants:
- Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a
condom, and agreement to refrain from donating sperm, as defined in Section 9.3.6
Exclusion criteria
- 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.
- Current malignancy or history of malignancy during the last five years, based on
anamnesis.
- Gastroenteritis within two weeks prior to vaccination.
- Regular use of laxatives, antacids or other agents that lower stomach acidity.
- Any planned major surgery during the duration of the study.
- After 10 minutes supine rest, any vital signs outside the following ranges:
- Systolic BP > 160 mm Hg
- Diastolic BP > 100 mm Hg
- Heart rate < 40 or >85 beats per minute
- Antibiotic therapy within two weeks prior to the vaccination.
- Known Hepatitis A, B, C, and/or HIV infection.
- Concomitant intake of immunomodulating drugs during the study period or less than 3
months prior to the first immunization. Local anti-histamine treatment is however
allowed.
- Any other significant medical conditions (e.g. poorly controlled psychiatric
condition) judged by the Investigator to preclude entry.
- Intends to receive any other vaccine during the study period, or within two weeks
prior to trial vaccination.
- Has previously received Dukoral or any type of ETEC or cholera vaccines.
- Brought up in ETEC-endemic areas (e.g., urban and rural areas of Central and South
America, Caribbean, most countries in Asia, Africa, etc.).
- Has travelled to ETEC-endemic areas within the last 3 years OR spent > two months in
ETEC endemic areas during the last 10 years.
- Intends to travel to ETEC endemic countries during the study period.
- Known or suspected history of drug, chemical or alcohol abuse, as deemed by the
investigator/physician.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
judged by the Investigator, or history of hypersensitivity to drugs with a similar
chemical structure or class to ETVAX®.
- Participation in any other clinical study that included drug treatment with the last
administration within the past 3 months prior to administration of study treatment in
this study. Patients consented and screened but not dosed in previous clinical studies
are not excluded.
- Concomitant participation in any other clinical study.
- Females who are pregnant as determined by urine test at inclusion and prior to each
vaccination.
- Females who are nursing.
- Unable to participate in all study visits.
- Any condition or circumstance which would make the subject unsuitable for
participation in the study in the opinion of the investigator/physician.
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