Cholera Vaccination Reaction Clinical Trial
Official title:
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
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | January 31, 2024 |
| Est. primary completion date | July 31, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 45 Years |
| Eligibility | Inclusion Criteria: 1. Healthy Korean participants aged 19 to 45 years at consent 2. Participants willing to provide written informed consent to participate study voluntarily 3. Participants who can be followed up during the study period and can comply with the study requirements 4. Individual in good health as determined by the outcome of medical history, physical examination, laboratory evaluations and the clinical judgment of the investigator 5. Females of childbearing potential with negative pregnancy test result on the day of screening 6. 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. 7. 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: 1. 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 2. Individuals with major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study 3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) 4. 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. 5. 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 6. Individuals with splenectomy 7. 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 8. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months 9. 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 10. Body mass index (BMI) = 35 kg/m2 11. Individuals with active or previous Vibrio cholerae infection 12. Individuals with history of severe diarrhea requiring hospitalization or emergency room visit for the last 5 years 13. Individuals with receipt of a cholera vaccine 14. Individuals who lived in cholera endemic areas for more than 6 months for the past 10 years 15. As per Investigator's medical judgement, an individual could be excluded from the study despite meeting all inclusion/exclusion criteria mentioned above 16. Any female participant who is lactating*, pregnant or planning for pregnancy** during study period 17. Individuals enrolled in another clinical trial or bioequivalence test during 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial 18. Individuals who are research staff involved with the clinical study or family/household members of research staff |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | CHA Bundang Medical Center (CBMC) of CHA University | Seoul | |
| Korea, Republic of | Soon Chun Hyang University Hospital | Seoul | |
| Korea, Republic of | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| International Vaccine Institute | EuBiologics Co.,Ltd, Massachusetts General Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Seroconversion of serum anti-TT antibody titer | Proportion of participants achieving seroconversion (defined as at least 4-fold increase) of serum anti-TT antibody titer at 28 days after first and second dose vaccination compared to baseline | Baseline and at 28 days post the first and second dose | |
| Other | Memory B Cell responses | Memory B Cell responses measured by Elispot assay at 28 days after the first dose vaccination and 6 months after second dose vaccination compared to baseline. | Baseline, 28 days, and 6 months | |
| Primary | 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) | |
| Primary | Immediate adverse events | Occurrence of immediate adverse events within 30 minutes from the time of each study vaccination. | Within 30 minutes post each dose | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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. | Within 28 days post each dose | |
| Secondary | Seroconversion rates of IgG antibody responses to OSP | Proportion of participants achieving seroconversion (defined as a 4-fold increase of serum anti-OSP IgG antibody titer at approximately 28 days after the first and second dose of investigational product compared to baseline | Baseline and at 28 days post the first and second dose | |
| Secondary | Geometric Mean Titers (GMTs) of serum anti-OSP IgG | GMTs of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product compared to baseline | Baseline and at 28 days post the first and second dose | |
| Secondary | Geometric Mean Fold Rise (GMFR) of serum anti-OSP IgG | GMFR of serum anti-OSP IgG antibodies at 28 days after the first and second dose of investigational product | At 28 days post the first and second dose | |
| Secondary | Seroconversion rates of serum vibriocidal antibody titers | Proportion of participants with a 4-fold or greater rises in serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa, relative to baseline, 28 days after the first and second dose of investigational product compared to baseline | Baseline and at 28 days post the first and second dose | |
| Secondary | GMT of serum vibriocidal antibody titers | Geometric Mean Titers (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa at 28 days after the first and second dose of investigational product compared to baseline
. |
Baseline and at 28 days post the first and second dose | |
| Secondary | GMFR of serum vibriocidal antibody titers | GMFR of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa at 28 days after the first and second dose of investigational product | At 28 days post the first and second dose |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03719066 -
Extended Dose Intervals With Oral Cholera Vaccine in Cameroon
|
Phase 2 |