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New treatment option for Cholera Vaccination
Official title Extended Dosing Intervals Trial for Oral Cholera Vaccine, Kenya
ClinicalTrials.gov ID: NCT07487077
What this study is testing
What is Euvichol-S Oral Cholera Vaccine?
Euvichol-S Oral Cholera Vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cholera vaccination.
Also referred to as cholera: inactivated oral, Euvichol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Despite efforts to control cholera, outbreaks continue to occur in Kenya. Oral cholera vaccines (OCVs) are a critical tool in cholera prevention strategies.
- Phase 4: studies an already-approved treatment
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Ability to comply with study requirements and attend follow-up visits during the study period. Participants must be in good health, as determined by...
- Lactating women may be enrolled following clinical assessment and informed consent. The vaccine contains killed, formalin-inactivated bacteria that...
You likely can't join if
- 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...
- Reported diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation; to avoid confounding the vaccine's effects...
- Received a cholera vaccine in the last 24 months: Ensures that the study assesses the vaccine in question without interference from prior...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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 how well it works. In...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nairobi, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nairobi, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.