Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
NCT ID: NCT06104345
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
65 participants
INTERVENTIONAL
2023-10-25
2024-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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)
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vivotif
Three oral doses of typhoid fever vaccine (Vivotif®).
Oral typhoid fever vaccine
Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
Dukoral
Two oral doses of cholera vaccine (Dukoral®).
Oral cholera vaccine
Oral cholera vaccine (Dukoral®) on Days 0 and 7.
Dukoral+Vivotif
Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously.
Oral typhoid fever vaccine
Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
Oral cholera vaccine
Oral cholera vaccine (Dukoral®) on Days 0 and 7.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral typhoid fever vaccine
Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.
Oral cholera vaccine
Oral cholera vaccine (Dukoral®) on Days 0 and 7.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. General good health as established by medical history and physical examination.
3. Written informed consent.
4. 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.
5. Available for all visits scheduled in this study.
Exclusion Criteria
2. History of clinical typhoid fever or cholera.
3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study period or vaccination planned during it.
4. Current intake of antibiotics or end of antibiotic therapy \<8 days before first IMP administration.
5. 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.
6. Acute or chronic clinically significant gastrointestinal disease.
7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
8. Pregnancy or lactation.
9. 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).
10. Alcohol or drug abuse.
11. Suspected non-compliance.
12. Use of any investigational drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
13. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator.
14. Employee at the investigational site or relative or spouse of the investigator.
15. 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Helsinki
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anu Kantele
MD, PhD, Professor of Infectious Diseases
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anu Kantele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Meilahti Vaccine Research Center, Helsinki University Hospital
Helsinki, , Finland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dukoral+Vivotif
Identifier Type: -
Identifier Source: org_study_id