Vaccine-Preventable DiseasesPhase 4NCT06104345
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
A Phase 4 study testing Oral typhoid fever vaccine and Oral cholera vaccine in people with Vaccine-Preventable Diseases and Typhoid Fever, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine-Preventable Diseases, Typhoid Fever, Cholera
- What is being tested?
- Oral typhoid fever vaccine and Oral cholera vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFinland
- Study dates
- 25 Oct 2023to 26 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Vaccination against typhoid fever or cholera within 5 years before dosing.
- History of clinical typhoid fever or cholera.
- 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.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Pregnancy or lactation.
- Acute disease at the time of enrolment (defined as the presence of a moderate or severe illness with or without fever (fever defined as body temperature of ≥38 °C).
- Alcohol or drug abuse.
- Suspected non-compliance.
- Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
- Employee at the investigational site or relative or spouse of the investigator.
- Any other criteria which, in the investigator's opinion, would compromise the ability of a subject to participate in the study, a subject's well-being, or the outcome of the study.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Meilahti Vaccine Research Center, Helsinki University Hospital
Helsinki, 00290
About this study
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
Read more
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)
- Conditions
- Vaccine-Preventable Diseases, Typhoid Fever, Cholera
- Being tested
- Oral typhoid fever vaccine, Oral cholera vaccine
- Keywords
- Immunogenicity, Coadministration, ELISPOT, B cells, Oral vaccination, Salmonella Typhi, Vibrio cholerae
- Medical subject headings
- Vaccine-Preventable Diseases, Typhoid Fever, Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral typhoid fever vaccineBiological
Also called Vivotif®
Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
Oral cholera vaccineBiological
Also called Dukoral®
Oral cholera vaccine (Dukoral®) on Days 0 and 7.
| Study group | Role | What they receive |
|---|---|---|
| Vivotif | Active comparator | Three oral doses of typhoid fever vaccine (Vivotif®). Receives: Biological: Oral typhoid fever vaccine |
| Dukoral | Active comparator | Two oral doses of cholera vaccine (Dukoral®). Receives: Biological: Oral cholera vaccine |
| Dukoral+Vivotif | Experimental | Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously. Receives: Biological: Oral typhoid fever vaccine; Biological: Oral cholera vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
Secondary outcomes (1)
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)
Measured: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start25 Oct 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine-Preventable DiseasesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Anu Kantele, Helsinki University Central Hospital
- Investigators
- Anu Kantele, MD, PhD, Principal investigator, Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104345
- Sponsor's protocol ID
- Dukoral+Vivotif
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
- ClinicalTrials.gov ID
- NCT06104345
- Acronym / sponsor ID
- Dukoral+Vivotif
- Conditions
- Vaccine-Preventable Diseases, Typhoid Fever, Cholera
- Keywords
- Immunogenicity, Coadministration, ELISPOT, B cells, Oral vaccination, Salmonella Typhi, Vibrio cholerae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vivotif | Active comparator | Biological: Oral typhoid fever vaccineThree oral doses of typhoid fever vaccine (Vivotif®). |
| Dukoral | Active comparator | Biological: Oral cholera vaccineTwo oral doses of cholera vaccine (Dukoral®). |
| Dukoral+Vivotif | Experimental | Biological: Oral typhoid fever vaccine, Biological: Oral cholera vaccineOral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- Vaccination against typhoid fever or cholera within 5 years before dosing.
- History of clinical typhoid fever or cholera.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral typhoid fever vaccineAlso: Vivotif®Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4. | Biological | Dukoral+Vivotif, Vivotif |
| Oral cholera vaccineAlso: Dukoral®Oral cholera vaccine (Dukoral®) on Days 0 and 7. | Biological | Dukoral, Dukoral+Vivotif |
Primary outcome
Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs)
Time frame: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
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).
1 secondary outcome
Titer of antigen-specific antibodies in lymphocyte supernatants (ALS) to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines.
Time frame: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Kantele, MD, PhD principal investigator
Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral typhoid fever vaccine and Oral cholera vaccine in people with Vaccine-Preventable Diseases and Typhoid Fever, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of antigen-specific plasmablast responses to oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines (ASCs/million PBMCs) (time frame: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.