Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Chole… (NCT06104345) | Clinical Trial Compass
CompletedPhase 4
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
Finland65 participantsStarted 2023-10-25
Plain-language summary
The goal of this clinical trial is to explore the coadministration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines in healthy volunteers aged 18-65 years. The main question it aims to answer is:
• Does coadministration impact the immune responses to Vivotif® and Dukoral® vaccines
Participants will:
* receive either oral typhoid fever (Vivotif®) or oral cholera (Dukoral®) vaccines or both simultaneously
* give blood samples for immunogenicity analyses
* participate in adverse event follow up
Researchers will compare those receiving only one of the vaccines to those receiving both simultaneously to see if coadministration has an impact on antigen-specific responses measured with:
* ELISPOT (plasmablast responses specific to Salmonella typhi, Vibrio Cholerae and Enterotoxigenic Escherichia coli)
* ELISA (antibodies in lymphocyte supernatants (ALS) and serum antibodies specific to vaccine antigens)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged ≥18 to ≤65 years.
. General good health as established by medical history and physical examination.
. Written informed consent.
. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study (14 days before immunization to day 28 ± 3). Abstinence is acceptable.
. Available for all visits scheduled in this study.
Exclusion criteria
. Vaccination against typhoid fever or cholera within 5 years before dosing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs)
Timeframe: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
. Current intake of antibiotics or end of antibiotic therapy \<8 days before first IMP administration.
. Chronic (longer than 14 days) administration of immunosuppressants or other immunemodifying drugs within 6 months before the first dose of IMP; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids allowed.
. Acute or chronic clinically significant gastrointestinal disease.
. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.