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.
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
Must be able to understand the information included in the informed consent form and be willing to provide voluntary informed consent to participate in the study
Must agree to not take any medication affecting gastric acidity (such as proton pump inhibitor, H2 receptor blocker, or antacid) for 7 days prior to and until 24 hours after each vaccination.
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.
Parallel
DuoChol
Biological/VaccineA 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).
Dukoral®
Biological/Vaccine3 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.
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
Proportion of participants achieving seroconversion of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
seroconversion of serum vibriocidal antibody titers defined as at least 4-fold increase
Geometric Mean Titer (GMT) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Geometric Mean Fold Rise (GMFR) of serum vibriocidal antibody titers against V. cholerae O1 Inaba and V. cholerae O1 Ogawa.
Proportion of participants achieving seroconversion of serum IgG anti-CTB antibodies.
seroconversion of serum IgG anti-CTB antibodies defined as at least 2-fold increase
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