Could a Once-a-Year cholera shot be just as good?
NCT ID NCT07487077
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study in Nairobi, Kenya, is testing whether giving the oral cholera vaccine Euvichol-S at longer intervals (3 months or 12 months) works as well as the standard 2-week schedule. Over 1,000 healthy participants aged 1 year and older will be randomly assigned to one of three dosing schedules. The goal is to see if flexible timing can still protect against cholera, which could make vaccination campaigns easier in areas where outbreaks are common.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Euvichol-S oral cholera vaccine
- What this could lead to
- If successful, this could allow more flexible vaccination schedules, making it easier to protect communities against cholera in outbreak-prone areas.
- What could go wrong
- This is a Phase 4 trial, but it is still early for these specific dosing schedules. The results may not apply to other regions or populations, and the vaccine may not provide the same level of protection with longer intervals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,071 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Residents of Mukuru, Nairobi, Kenya * Individuals aged 1 year and above * Voluntary written informed consent for study participation provided by an individual or his/her legally acceptable representative. Children aged 13 years and above will also provide assent, with parental permission required for all children. * Ability to comply with study requirements and attend follow-up visits during the study period. Participants must be in good health, as determined by medical history, physical examination, and the clinical judgment of the investigators. Clinical judgment will consider factors such as the absence of acute illness or, uncontrolled or severe chronic conditions that may affect participation in the study. * Lactating women may be enrolled following clinical assessment and informed consent. The vaccine contains killed, formalin-inactivated bacteria that are not systemically absorbed and act locally in the gastrointestinal tract. Exclusion Criteria: * Known history of hypersensitivity reactions to other vaccines. * Pregnant women, due to differences in immune response. A pregnancy test will be administered to all female participants who have reached menarche and are under 50 years. * Reported diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation; to avoid confounding the vaccine's effects with pre-existing conditions. * Received a cholera vaccine in the last 24 months: Ensures that the study assesses the vaccine in question without interference from prior vaccinations. * History of cholera disease in the last 24 months: Recent history of cholera infection can interfere with the measurement of vaccine response. * Severely malnourished individuals as determined by mid-upper arm circumference (MUAC) and age-specific body mass index (BMI) measurements: malnutrition can affect immune response and vaccine efficacy. In children below 510 years, severe malnutrition will be defined as MUAC \< 11.5 cm, for older children (age 5 - 17y) severe malnutrition will be defined as BMI-for-age z score \< -3 (WHO Child Growth Standards), for children \<10y, presence of bilateral pitting oedema will be considered indicative of severe malnutrition. For adults (18y and above), severe malnutrition will be while in older children and adults it will be defined as BMI \< 16. * Non-HIV/AIDS immunosuppressive condition or on immunosuppressive therapy: Such conditions can significantly alter vaccine response. * Presence of bleeding disorders or medical contraindication for blood draws: To ensure participant safety during blood collection. * Participation in another clinical trial with investigational product dosing within 6 months prior to study initiation. * An individual thought to have difficulty in participating in the study due to severe chronic diseases, based on the judgment of the investigator. * An individual thought to have difficulty participating in the study due to reasons, such as significant logistical constraints, or communication barriers, or likely to be away for a period of at least 3 consecutive months in the first 6 months of enrollment based on the judgment of the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KEMRI
RECRUITINGNairobi, Kenya
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