A Phase I, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in 19 to 45 Years Old Healthy Korean Participants
Sponsor study identifier
interventional
150
1 country
3
Study Start
December 5, 2022
Actual (reported)Primary Completion
September 8, 2023
Actual (reported)Study Completion
January 23, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 23, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 21, 2022
Actual (reported)September 29, 2022
Actual (reported)December 5, 2022
Actual (reported)September 8, 2023
Actual (reported)January 23, 2024
Actual (reported)Serious adverse events (SAEs) and adverse events of special interest (AESIs)
Occurrence of any SAEs/AESIs from the time of the first dose of study vaccine
Entire study participation period (approximately 7 months)
Immediate adverse events
Occurrence of immediate adverse events within 30 minutes from the time of each study vaccination.
Within 30 minutes post each dose
Solicited adverse events
Occurrence of solicited injection site and solicited systemic adverse events from the time of each study vaccination through 7 days after each study vaccination
Within 7 days post each dose
Unsolicited adverse events
Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.
Within 28 days post each dose
Clinical safety laboratory parameters
Occurrence of clinically significant changes in clinical safety laboratory parameters from the time of each vaccination through 28 days after each study vaccination.
Seroconversion rates of IgG antibody responses to OSP
Baseline and at 28 days post the first and second dose
Geometric Mean Titers (GMTs) of serum anti-OSP IgG
Baseline and at 28 days post the first and second dose
Geometric Mean Fold Rise (GMFR) of serum anti-OSP IgG
At 28 days post the first and second dose
Seroconversion rates of serum vibriocidal antibody titers
Baseline and at 28 days post the first and second dose
GMT of serum vibriocidal antibody titers
Baseline and at 28 days post the first and second dose
Seroconversion of serum anti-TT antibody titer
Baseline and at 28 days post the first and second dose
Memory B Cell responses
Baseline, 28 days, and 6 months
2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
2 doses @0.5 mL of test vaccine administered intramuscularly in deltoid region at 4 weeks apart
OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 5 µg of OSP:rTTHc
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 5 µg of OSP:rTTHc
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591, South Korea
CHA Bundang Medical Center (CBMC) of CHA University
Seoul, 08826, South Korea
Soon Chun Hyang University Hospital
Seoul, 08826, South Korea
Kelly M, Janardhanan J, Wagh C, Verma S, Charles RC, Leung DT, Kamruzzaman M, Pansuriya RK, Chowdhury F, Vann WF, Kaminski RW, Khan AI, Bhuiyan TR, Qadri F, Kovac P, Xu P, Ryan ET. Development of a Shigella conjugate vaccine targeting Shigella flexneri 6 that is immunogenic and provides protection against virulent challenge. Vaccine. 2024 Oct 24;42(24):126263. doi: 10.1016/j.vaccine.2024.126263. Epub 2024 Aug 31.
Kelly M, Jeon S, Yun J, Lee B, Park M, Whang Y, Lee C, Charles RC, Bhuiyan TR, Qadri F, Kamruzzaman M, Cho S, Vann WF, Xu P, Kovac P, Ganapathy R, Lynch J, Ryan ET. Vaccination of Rabbits with a Cholera Conjugate Vaccine Comprising O-Specific Polysaccharide and a Recombinant Fragment of Tetanus Toxin Heavy Chain Induces Protective Immune Responses against Vibrio cholerae O1. Am J Trop Med Hyg. 2023 Oct 2;109(5):1122-1128. doi: 10.4269/ajtmh.23-0259. Print 2023 Nov 1.
Anh Wartel, MD
+82 2 8811 274
150 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2022
Within 28 days post each dose
2 doses @0.5 mL of Sterile 0.9% sodium chloride administered intramuscularly in deltoid region at 4 weeks apart
Sterile 0.9% sodium chloride
OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 10 µg of OSP:rTTHc
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 10 µg of OSP:rTTHc
Sterile 0.9% sodium chloride
OSP:rTTHc Cholera Conjugate Vaccine without Aluminum phosphate with dose formulation 25 µg of OSP:rTTHc
OSP:rTTHc Cholera Conjugate Vaccine with Aluminum phosphate with dose formulation 25 µg of OSP:rTTHc
Sterile 0.9% sodium chloride
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
September 29, 2022
Study Start
December 5, 2022
Actual (reported)Primary Completion
September 8, 2023
Actual (reported)Study Completion
January 23, 2024
Actual (reported)Last Updated
March 25, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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