Phase
Condition
N/ATreatment
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort B
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate adjuvant Cohort A
Placebo Cohort B
Clinical Study ID
Ages 19-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy Korean participants aged 19 to 45 years at consent
Participants willing to provide written informed consent to participate studyvoluntarily
Participants who can be followed up during the study period and can comply with thestudy requirements
Individual in good health as determined by the outcome of medical history, physicalexamination, laboratory evaluations and the clinical judgment of the investigator
Females of childbearing potential with negative pregnancy test result on the day ofscreening
Females of childbearing potential who agree to use an effective birth controlmethod* from the screening and p to 12 weeks after the second dose vaccination.
Males who agree to use an effective birth control method* from the screening and upto 12 weeks after the second dose vaccination
Exclusion
Exclusion Criteria:
Known history or allergy to investigational vaccine components and/or excipients orother medications, or any other allergies deemed by the investigator to increase therisk of an adverse event if they were to participate in the trial
Individuals with major congenital abnormalities which in the opinion of investigatormay affect the participant's participation in the study
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 forperiods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapyor other immunosuppressive drugs within the past 6 months.
Individuals with behavioral or cognitive impairment or psychiatric disease or neuraldisorders that, in the opinion of the investigator, could interfere with theparticipant's ability to participate in the trial
Individuals with splenectomy
Individuals with a known bleeding diathesis, or any condition that may be associatedwith a prolonged bleeding time resulting in contraindication for intramuscularinjections/blood extractions
Receipt of blood, blood-derived products, or immunoglobulin products in the past 3months
Individuals who have received other vaccines from 4 weeks prior to the first dose oftest vaccination or planned to receive any vaccine within 4 weeks of the last doseof the investigational product
Body mass index (BMI) ≥ 35 kg/m2
Individuals with active or previous Vibrio cholerae infection
Individuals with history of severe diarrhea requiring hospitalization or emergencyroom visit for the last 5 years
Individuals with receipt of a cholera vaccine
Individuals who lived in cholera endemic areas for more than 6 months for the past 10 years
As per Investigator's medical judgement, an individual could be excluded from thestudy despite meeting all inclusion/exclusion criteria mentioned above
Any female participant who is lactating*, pregnant or planning for pregnancy**during study period
Individuals enrolled in another clinical trial or bioequivalence test during 6months prior to enrollment, concomitantly enrolled or scheduled to be enrolled inanother trial
Individuals who are research staff involved with the clinical study orfamily/household members of research staff
Study Design
Study Description
Connect with a study center
CHA Bundang Medical Center (CBMC) of CHA University
Seoul, 08826
Korea, Republic ofSite Not Available
Soon Chun Hyang University Hospital
Seoul, 08826
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available

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