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 range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female subjects aged ≥18 to ≤65 years.
âś“. General good health as established by medical history and physical examination.
âś“. 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.
âś“. Available for all visits scheduled in this study.
Exclusion criteria
âś•. Vaccination against typhoid fever or cholera within 5 years before dosing.
âś•. History of clinical typhoid fever or cholera.
âś•. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
âś•. Current intake of antibiotics or end of antibiotic therapy \<8 days before first IMP administration.
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.
. 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.
âś•. Acute or chronic clinically significant gastrointestinal disease.
âś•. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.