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Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children

ConditionCholera Vaccination
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-45
SponsorInternational Vaccine Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate

    Biological/Vaccine

    OSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10

  • OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate

    Biological/Vaccine

    OSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4

  • Euvichol®-Plus

    Biological/Vaccine

    V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6

  • Placebo

    Other intervention

    Sterile 0.9% sodium chloride cohort Arms A5, B5, C5

  • CCV with Aluminum, Euvichol®-Plus

    Biological/Vaccine

    1. OSP:rTTHc CCV 25 # with Aluminum phosphate OSP:rTTHc Cholera Conjugate with Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C7, C9

  • CCV without Aluminum, Euvichol®-Plus

    Biological/Vaccine

    1. OSP:rTTHc CCV 25 # without Aluminum phosphate OSP:rTTHc Cholera Conjugate without Aluminum phosphate 2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine Cohort Arms C8, C10

Treatment groups

390 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphateExperimental treatment 1 intervention
Group B: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphateExperimental treatment 1 intervention
Group C: Euvichol®-PlusActive comparator 1 intervention
Group D: Isotonic Sodium Chloride injectionPlacebo comparator 1 intervention
Group E: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate and Euvichol®-PlusExperimental treatment 1 intervention
Group F: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-PlusExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seroconversion of Serum vibriocidal antibody titers responses to V. cholerae O1 Inaba and O1 Ogawa at 28 days after one dose vaccination of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years).

\- Proportion of participants achieving seroconversion (defined as at least 4-fold increase from baseline) of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo

Time frame
Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
2

GMT of Serum vibriocidal antibody titers to V. cholerae O1 Inaba and O1 Ogawa after one dose of CCV 25 μg (with or without alum) in adults (aged 18 to 45 years) and in children (aged 1 to 17 years)

\- GMT of serum vibriocidal antibody titers at 28 days after one dose vaccination of CCV (with or without alum) 25 μg / placebo

Time frame
Baseline and at 28 days post the first dose of either CCV with alum, CCV without alum or placebo
3

Seroconversion of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years

Proportion of participants achieving seroconversion of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus

Time frame
Baseline and at 14 days post two doses of Euvichol®-Plus
4

GMT of vibriocidal titers against V. cholerae O1 Inaba and O1 Ogawa after two doses of Euvichol®-Plus in children aged 1 to 4 years

GMT of serum vibriocidal antibody titers at 14 days after two doses of Euvichol®-Plus compared to baseline

Time frame
Baseline and at 14 days after two doses of Euvichol®-Plus

Secondary outcomes

1

Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE)

Occurrence of any SAE / AESI / MAAE from the first dose vaccination throughout the final study visit

Time frame
through study completion, an average of 6 months
2

Immediate adverse events

Occurrence of immediate adverse events within 30 minutes after each dose vaccination

Time frame
Within 30 minutes post each dose
3

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

Time frame
Within 7 days post each dose
4

Unsolicited adverse events

Occurrence of unsolicited adverse events from the time of each study vaccination through 28 days after each study vaccination.

Time frame
Within 28 days post each dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Vaccine Institute

Lead sponsor

EuBiologics Co.,Ltd

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov
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