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Tests treatment safety and results for Cholera Vaccination
Official title Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children
ClinicalTrials.gov ID: NCT07509047
What this study is testing
What is OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate?
OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cholera vaccination.
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
- This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Individuals aged 1 to 45 years at consent
- Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study...
- Participants who can comply with the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
You likely can't join if
- Known history or allergy to investigational vaccine components or other medications, or any other allergies
- Individuals with major congenital abnormalities
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)
- Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy...
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with...
- Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could...
See the full eligibility criteria
- Individuals aged 1 to 45 years at consent
- Participants/ Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily
- Participants who can comply with the study requirements
- Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
- Known history or allergy to investigational vaccine components or other medications, or any other allergies
- Individuals with major congenital abnormalities
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)
- Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6...
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives
- Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial
- Individuals with splenectomy
- Individuals with known bleeding disorders
- Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months
- Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product.
- Individuals with active or known previous Vibrio cholerae infection
- Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more
- Individuals with prior receipt of a cholera vaccine in the last 5 years
- Any female participant who is lactating or pregnant
- Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination.
- Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period
- Individuals who are research staff involved with the clinical trial or family/household members of research staff
- As per Investigator's medical judgement, an individual could also be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above
- Children below 5 years old with Weight for Height Z score and/or Height for Age Z score of less than -2
The study team makes the final eligibility decision.
Where it's taking place
- Nairobi, Kenyatta National Hospital Complex, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nairobi, Kenyatta National Hospital Complex, 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.