Trials Sponsors Conditions Drugs Pricing

Conditions

Cholera Vaccination Reaction

Keywords

Oral Cholera VaccineDuoCholPhase 1 TrialV. cholerae O1 InabaV. cholerae O1 Ogawarecombinant cholera toxin B-subunit

Outcome Measures

Primary Outcomes (1)

Safety of each investigational product dose at a specified duration
1. Occurrence of any SAEs from the first dose vaccination until 28 days after the second dose vaccination. 2. Occurrence of immediate adverse events within 2 hours after the first dose of vaccination for the sentinel cohort of participants, and within 1 hour for the rest of the participants 3. Occurrence of solicited gastrointestinal and systemic adverse events within 7 days after each vaccination 4. Occurrence of unsolicited adverse events within 14 days after each vaccination 5. Occurrence of clinically significant changes in safety laboratory parameters after each vaccination
From enrollment to the end of study, approximately 6 weeks for each participant.

Secondary Outcomes (6)

Proportion of participants achieving seroconversion of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Fold Rise (GMFR) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Proportion of participants achieving seroconversion of serum IgG anti-CTB antibodies.
Baseline (prior to first vaccination) to 14 days after the first and second vaccination.
Geometric Mean Titer (GMT) of serum IgG anti-CTB antibodies.
Baseline (prior to first vaccination) to 14 days after the first and second vaccination.

Study Arms (2)

DuoChol

EXPERIMENTAL

2 doses of DuoChol capsule administered orally 14 days apart (Day 0 and Day 14).

Biological: DuoChol

Dukoral®

ACTIVE COMPARATOR

2 doses of Dukoral® administered orally 14 days apart (Day 0 and Day 14). Vaccine suspension is mixed with the buffer (sodium hydrogen carbonate) solution, supplied as effervescent powder.

Biological: Dukoral®

Interventions

DuoCholBiological

A lyophilized formulation in capsule form (approximately 150mg) contains: - 0.9 mg in 1:1 ratio of formalin inactivated bacteria of two isogenic V. cholerae O1 El Tor strains: serotype Inaba (MS1955) and serotype Ogawa (MS1987) - 0.9 mg of recombinant cholera toxin B subunit (rCTB).

DuoChol

Dukoral®Biological

3 ml of suspension in a vial contains: * 31.25x10\^9 bacteria\* (approximately) of each of the following V. cholerae O1 strains: Inaba classical biotype (heat inactivated), Inaba El Tor biotype (formalin inactivated), Ogawa classical biotype (heat inactivated), Ogawa classical biotype (formalin inactivated) * 1 mg Recombinant cholera toxin B subunit (rCTB) 5.6 g of effervescent powder (buffer) in a sachet contains Sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavor.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or female participants aged 18 to 45 years, inclusive, at the time of signing the informed consent.
Must have a Swedish (or other nationality) identity card

Sponsors & Collaborators

International Vaccine Institute
Otherlead

Study Sites (1)

Studieenheten Akademiskt Specialistcentrum

Stockholm, Sweden

Helena H Askling, MD, PhDCONTACThelena.hervius.askling@ki.se

Helena H Askling, MD, PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Interventions

Dukoral

Study Officials

Jessica Cowden, MD
International Vaccine Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Cowden, MD

CONTACT

+46732377579 jessica.cowden@ivi.int

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 8, 2025

Study Start

January 2027

You may not qualify if:

Any clinically significant symptom of acute illness (e.g., cough, sore throat), febrile illness (tympanic temperature \>38°C) within 72 hours prior to the enrollment. A prospective participant should not be included until 72 hours after the condition has completely resolved.
Participant with diarrhea, abdominal pain or vomiting in the past 24 hours or with history of diarrhea lasting for more than 2 weeks in the past 6 months.
Known history of any immunocompromised condition, including immunodeficiency disease, renal function disorder, malignancy, chronic inflammatory disease, etc.
Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for period exceeding 2 consecutive weeks), or history of having received chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.
Participant who has ever received previous immunization with cholera vaccine, who has received any vaccine within 4 weeks prior to the first dose of study vaccination, or who plans to receive any other vaccine within 4 weeks following last dose of the investigational product.
Participant concomitantly enrolled or scheduled to be enrolled in another trial.
Participant with previous history of confirmed cholera, salmonella, shigella or ETEC disease.
Known history or allergy to vaccine components, or any other allergies deemed by the investigator to increase risk of an adverse event during trial participation.
Individuals with a known bleeding disorder, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for blood sample collection.
Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.
Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant or interfere with the assessment of the study objectives.
Any female participant who is lactating\*, pregnant, or planning for pregnancy during study period.
Individuals who are involved in DuoChol Clinical trial or family/household members of research staff.
Any other condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or psychiatric conditions etc.).

Safety and Immunogenicity Study of the DuoChol Oral Cholera Vaccine in Healthy Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

DuoChol

Dukoral®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

DuoChol

Dukoral®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations