Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07487077 for Cholera Vaccination is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Extended Dosing Intervals Trial for Oral Cholera Vaccine, Kenya Phase 4 1,071 Vaccine Study Randomized Pregnancy Open-Label
Clinical Trial NCT07487077 is designed to study Health Services Research for Cholera Vaccination. It is a Phase 4 interventional study that is recruiting, having started on 31 October 2025, with plans to enroll 1,071 participants. Led by Albert B. Sabin Vaccine Institute, it is expected to complete by 1 June 2028. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
Brief Summary
Background: Despite efforts to control cholera, outbreaks continue to occur in Kenya. Oral cholera vaccines (OCVs) are a critical tool in cholera prevention strategies. This study evaluates the immunogenicity of extended dosing intervals for Euvichol-S, a WHO-prequalified OCV, in a Phase IV non-inferiority trial.
Overview Design: This trial is a parallel-group, open-label, randomized, non-inferiority study. It aims ...
Show MoreDetailed Description
Study Rationale Between October 2022 and February 2024, Kenya has experienced a cholera outbreak with over 10,000 reported cases and 166 deaths across 23 counties. Alarmingly, children under 10 years of age account for one-third of the documented cases, indicating their heightened vulnerability to the disease. In February 2023, Kenya vaccinated more than 2.2 million people with a single dose of oral cholera vaccine (...Show More
Official Title
A Phase IV Parallel-Group, Open-Label, Randomized Non-Inferiority Trial Evaluating Immunogenicity of Extended Dosing Intervals for Euvichol-S Oral Cholera Vaccine, Nairobi, Kenya
Conditions
Cholera VaccinationOther Study IDs
- Sabin-OCV-24
- Wellcome Grant Number: 228242/ (Other Identifier) (Wellcome Trust)
NCT ID Number
Start Date (Actual)
2025-10-31
Last Update Posted
2026-03-23
Completion Date (Estimated)
2028-06
Enrollment (Estimated)
1,071
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Cholera
extended dosing
Euvichol-S
OCV
vaccination
immunization
extended dosing
Euvichol-S
OCV
vaccination
immunization
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard Dosing Arm (Two Weeks Interval) Participants received the second OCV dose per the recommended dosing schedule 2 weeks after the initial dose. | Euvichol-S Oral Cholera Vaccine Parallel-group, phase IV, open-label, randomized, non-inferiority trial
Arms:
Three distinct arms, each balanced in a 1:1:1 ratio:
Standard Dosing Arm (Two Weeks Interval) Extended Interval Dosing Arm (Three Months Interval) Annual Booster Dosing Arm (Twelve Months Interval)
Each dosing arm will have the following three age strata:
Children aged 1-4 years Children aged 5-14 years Adults aged 15 years and older |
ExperimentalExtended Interval Dosing Arm (Three Months Interval) Participants received the second OCV dose 3 months after the initial dose. | Euvichol-S Oral Cholera Vaccine Parallel-group, phase IV, open-label, randomized, non-inferiority trial
Arms:
Three distinct arms, each balanced in a 1:1:1 ratio:
Standard Dosing Arm (Two Weeks Interval) Extended Interval Dosing Arm (Three Months Interval) Annual Booster Dosing Arm (Twelve Months Interval)
Each dosing arm will have the following three age strata:
Children aged 1-4 years Children aged 5-14 years Adults aged 15 years and older |
ExperimentalAnnual Booster Dosing Arm (Twelve Months Interval) Participants received the second OCV dose 12 months after the initial dose. | Euvichol-S Oral Cholera Vaccine Parallel-group, phase IV, open-label, randomized, non-inferiority trial
Arms:
Three distinct arms, each balanced in a 1:1:1 ratio:
Standard Dosing Arm (Two Weeks Interval) Extended Interval Dosing Arm (Three Months Interval) Annual Booster Dosing Arm (Twelve Months Interval)
Each dosing arm will have the following three age strata:
Children aged 1-4 years Children aged 5-14 years Adults aged 15 years and older |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To assess and compare the immune response to Euvichol-S, measured by plasma vibriocidal geometric mean titer (GMT) two weeks after the second vaccine dose, across different dosing intervals in participants aged 1 year and older. | Plasma Vibriocidal GMT Measurement: Measurement of the concentration of plasma vibriocidal GMT two weeks after administering the second dose of Euvichol-S. Vibriocidal antibodies are the best-established immune correlate of protection against cholera. The GMT, a statistical representation of the antibody levels in the study population, is an objective and quantifiable measure of the vaccine's immunogenicity. By comparing GMT values across different dosing intervals, we aim to validate the immunogenicity of extended dosing schedules, assessing if they are as effective at eliciting a protective immune response as the standard two-week interval. This assessment will be crucial in guiding future vaccination strategies, particularly in resource-limited settings where scheduling flexibility can significantly impact public health outcomes. | Plasma vibriocidal GMT measurement 2-weeks after the 2nd vaccine dose of Euvichol-S in participants 1+ years for the Comparator Arm (2nd dose at 2 weeks), Intervention Arm 1 (2nd dose at 3-months), and Intervention Arm 2 (2nd dose at 1-year) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Plasma Vibriocidal GMT | Plasma Vibriocidal GMT Comparison: Compare the concentration of plasma vibriocidal geometric mean titer (GMT) across various dosing intervals within distinct age groups to determine whether the average antibody levels within each age strata varies by the vaccine dosing schedule.
Vibriocidal Antibody Seroconversion Evaluation: Assess the proportion of vaccinees who had a 4-fold or greater rise in vibriocidal titers after vaccination, indicating the development of an immune response to the vaccine.
Longitudinal GMT Changes Monitoring: Describe plasma vibriocidal GMT over an 18-month period: two weeks post-vaccination and also at 6, 12, and 18 months post-enrollment; this outcome tracks the persistence and variation of GMT by dosing interval and age to understand the duration and stability of the immune response elicited by the vaccine.
Cholera Disease Incidence Comparison: Compare the incidence of cholera over 18 months across different age groups and dosing intervals. | Plasma vibriocidal GMT over an 18-month period: two weeks post-vaccination and also at 6, 12, and 18 months post-enrollment. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
1 Year
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Albert B. Sabin Vaccine InstituteStudy Central Contact
Contact: Samuel Kariuki, BVM, PhD, +254 722232467, [email protected]
Contact: Cecilia Mbae, PhD, +254 722485819, [email protected]
1 Study Locations in 1 Countries
KEMRI, Nairobi, Kenya
Samuel Kariuki, Contact
Recruiting