New cholera pill tested in sweden – first human study begins

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent. 2. Must have a Swedish (or other nationality) identity card 3. Must be able to understand the information included in the informed consent form and be willing to provide voluntary informed consent to participate in the study 4. Must agree to not take any medication affecting gastric acidity (such as proton pump inhibitor, H2 receptor blocker, or antacid) for 7 days prior to and until 24 hours after each vaccination. 5. Must be able to attend all scheduled study visits and comply with all study procedures. 6. Must be in good general health and without clinically significant medical history, as determined by the study investigator using clinical judgement after review of medical history, physical examination, and laboratory screening tests (hematology, renal function, and liver function tests). 7. Female-Specific Criteria: 1. Not currently pregnant or breastfeeding and not planning to become pregnant for at least 12 weeks after last vaccination. 2. Negative urine pregnancy test at the time of vaccination. 3. Agree to use at least one acceptable an adequate birth control method for at least 4 weeks prior to receipt of vaccine and for at least 12 weeks after receipt of the vaccine. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tub l ligation), condoms, diaphragms, intrauterine device, or abstinence 8. Male-Specific Criteria: 1. Be willing to use an adequate birth control method during study participation and 12 weeks after the last vaccination. 2. For non-vasectomized male participants with female partners of child- bearing potential this includes the use of condoms or abstinence and/or their partner's use of contraceptive medications delivered orally, intramuscularly, vaginally, or implanted underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), diaphragms, or intrauterine device. Exclusion Criteria: 1. Any clinically significant symptom of acute illness (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C) within 72 hours prior to the enrollment. A prospective participant should not be included until 72 hours after the condition has completely resolved. 2. Participant with diarrhea, abdominal pain or vomiting in the past 24 hours or with history of diarrhea lasting for more than 2 weeks in the past 6 months. 3. Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc. 4. Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for period exceeding 2 consecutive weeks), or history of having received chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months. 5. Participant who has ever received previous immunization with cholera vaccine, who has received any vaccine within 4 weeks prior to the first dose of study vaccination, or who plans to receive any other vaccine within 4 weeks following last dose of the investigational product. 6. Participant concomitantly enrolled or scheduled to be enrolled in another trial. 7. Participant with previous history of confirmed cholera, salmonella, shigella or ETEC disease. 8. Known history or allergy to vaccine components, or any other allergies deemed by the investigator to increase risk of an adverse event during trial participation. 9. Individuals with a known bleeding disorder, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for blood sample collection. 10. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months. 11. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant or interfere with the assessment of the study objectives. 12. Any female participant who is lactating\*, pregnant, or planning for pregnancy during study period. 13. Individuals who are involved in DuoChol Clinical trial or family/household members of research staff. 14. Any other condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions etc.).