NCT07270796

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

A Phase I, Open-label, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 Years Old Healthy Participants in Sweden

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this phase I, open-label, randomized, active-controlled Trial is to evaluate the safety and immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old healthy participants in Sweden. This first-in-human study is intended to obtain initial data on the DuoChol oral cholera vaccine safety and its effect on immune responses in a cholera non-endemic setting to guide future studies in cholera endemic population. The Investigators will evaluate the safety and immunogenicity after each dose vaccination of DuoChol Oral Cholera Vaccine/Dukoral®. The participants will be randomly assigned to receive 2 vaccinations at 14-day intervals of DuoChol or Dukoral® in a 2:1 ratio. Participants in the DuoChol arm will receive one capsule of DuoChol on days 0 and 14. Participants in the Dukoral® arm will receive the standard dose as indicated in the Dukoral® package insert. The Investigators will follow-up the participants for 4 weeks after the second vaccination. The study is funded by Wellcome Trust, grant number : 226726/Z/22/Z.

Detailed description

A total of 60 healthy participants aged 18-45 in Sweden will be recruited and randomly assigned in a 2:1 ratio: 40 participants will receive DuoChol, 20 participants will receive Dukoral®. Each person will receive two doses of DuoChol or Dukoral® orally. There participants will have 6 scheduled study visits, including blood sampling for immunogenicity testing and safety assessment. Blood samples will be taken at screening, and then during the study, to check immune response and overall health status. Baseline tests include HIV, hepatitis, complete blood counts, and liver function test. Women of childbearing age will undergo pregnancy testing during screening and prior to each vaccination. All participants will be observed after vaccination for immediate reactions. Serious adverse events will be reported, and followed up till resolution, and participants are instructed to contact the Investigator team if they experience any serious adverse event. Study Objectives: * Primary: To evaluate the safety after each dose vaccination of DuoChol Oral Cholera Vaccine. * Secondary: To compare the immune response of DuoChol with the existing vaccine Dukoral® to assess whether DuoChol can generate a response in the immune system to protect against the disease. Key Endpoints: * Monitor for any serious adverse events like hospitalization, death, or significant disability that happen during the study that may or may not be related to the vaccines. * Track immediate reactions within 1-2 hours after vaccination to detect allergic or other immediate responses. * Record mild to moderate side effects such as nausea, fever, or diarrhea for up to 14 days after each dose. * Measure immune response in the blood 14 days after each dose.

Conditions

• Cholera Vaccination Reaction

Interventions

Type	Name	Description
BIOLOGICAL	DuoChol	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).
BIOLOGICAL	Dukoral®	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.

Timeline

• Start date: 2027-01-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-12-08
• Last updated: 2026-04-01

Locations

1 site across 1 country: Sweden