Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine … (NCT05559983) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Healthy Adults
South Korea150 participantsStarted 2022-12-05
Plain-language summary
This Phase I, first-in-human study is intended to primarily determine the safety of the dose range with or without Aluminum phosphate adjuvant expected to be needed for later clinical studies, to determine the nature of adverse reactions (i.e., safety profile) and to secondly assess the Aluminum phosphate humoral immune responses in non-endemic population to guide future dose selection.
Who can participate
Age range19 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy Korean participants aged 19 to 45 years at consent
✓. Participants willing to provide written informed consent to participate study voluntarily
✓. Participants who can be followed up during the study period and can comply with the study requirements
✓. Individual in good health as determined by the outcome of medical history, physical examination, laboratory evaluations and the clinical judgment of the investigator
✓. Females of childbearing potential with negative pregnancy test result on the day of screening
✓. Females of childbearing potential who agree to use an effective birth control method\* 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 up to 12 weeks after the second dose vaccination
Exclusion criteria
✕. Known history or allergy to investigational vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial
✕. Individuals with major congenital abnormalities which in the opinion of investigator may 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)
What they're measuring
1
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Timeframe: Entire study participation period (approximately 7 months)
. 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.
✕. 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 a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for intramuscular injections/blood extractions
✕. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months