Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants (NCT07270796) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants
Sweden60 participantsStarted 2027-01
Plain-language summary
The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®.
The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination.
The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.
Who can participate
Age range
18 Years – 45 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
. Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent.
. Must have a Swedish (or other nationality) identity card
. 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
. 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.
. Must be able to attend all scheduled study visits and comply with all study procedures.
. 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).
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 of each investigational product dose at a specified duration
Timeframe: From enrollment to the end of study, approximately 6 weeks for each participant.
. Not currently pregnant or breastfeeding and not planning to become pregnant for at least 12 weeks after last vaccination.
Exclusion criteria
. 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.
. 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.
. Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc.
. 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.
. 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.
. Participant concomitantly enrolled or scheduled to be enrolled in another trial.
. Participant with previous history of confirmed cholera, salmonella, shigella or ETEC disease.
. 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.