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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivotif | Active Comparator | Three oral doses of typhoid fever vaccine (Vivotif®). |
|
| Dukoral | Active Comparator | Two oral doses of cholera vaccine (Dukoral®). |
|
| Dukoral+Vivotif | Experimental | Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral typhoid fever vaccine | Biological | Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs) | Measurement of IgA -, IgG- and IgM-secreting antibody cells (ASC ELISPOT) specific to Salmonella typhi (whole cell), Vibrio cholerae (whole cell and CTB-toxin) and Enterotoxigenic Escherichia coli (ETEC whole cell and LTB-toxin). | Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Titer of antigen-specific antibodies in lymphocyte supernatants (ALS) to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines. | Measurement of anti-salmonella, anti-cholera and anti-ETEC antibodies in ALS samples (ELISA) | Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Titer of antigen-specific serum antibodies to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines. | Measurement of anti-salmonella, anti-cholera and anti-ETEC antibodies in serum (ELISA) | Blood samples on Days 0 and 28 ± 3 for all participants. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anu Kantele, MD, PhD | Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meilahti Vaccine Research Center, Helsinki University Hospital | Helsinki | 00290 | Finland |
The decision to share IPD will be done when the study is completed. IPD can be shared only if it does not compromise the anonymity of the study participants.
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| Oral cholera vaccine | Biological | Oral cholera vaccine (Dukoral®) on Days 0 and 7. |
|
|
| ID | Term |
|---|---|
| D000079263 | Vaccine-Preventable Diseases |
| D014435 | Typhoid Fever |
| D002771 | Cholera |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014735 | Vibrio Infections |
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| ID | Term |
|---|---|
| C072772 | Ty21a typhoid vaccine |
| D022121 | Cholera Vaccines |
| C586175 | Dukoral |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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