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.
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 months.
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Treatment groupsSee each treatment group below.
International Vaccine Institute
Lead sponsor
EuBiologics Co.,Ltd
Collaborator
Massachusetts General Hospital
Collaborator