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CompletedNCT06104345Updated Dec 5, 2024

Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines

A Phase 4 interventional study of Oral typhoid fever vaccine and Oral cholera vaccine in Vaccine-Preventable Diseases, Typhoid Fever and Cholera, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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)
02

Conditions studied

  • Vaccine-Preventable Diseases
  • Typhoid Fever
  • Cholera

Keywords

  • Immunogenicity
  • Coadministration
  • ELISPOT
  • B cells
  • Oral vaccination
  • Salmonella Typhi
  • Vibrio cholerae
03

In context

Vaccine-Preventable Diseases

54 studies on the registry are indexed under Vaccine-Preventable Diseases; 14 are open to participants now.

This study's enrollment of 65 is below the median of 180 across 41 interventional studies indexed under Vaccine-Preventable Diseases.

Browse Vaccine-Preventable Diseases studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Browse Helsinki University Central Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects aged ≥18 to ≤65 years.
  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

Exclusion Criteria:

  1. Vaccination against typhoid fever or cholera within 5 years before dosing.
  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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    Vivotif

    Three oral doses of typhoid fever vaccine (Vivotif®).

    Biological: Oral typhoid fever vaccine

  • Active comparator
    Dukoral

    Two oral doses of cholera vaccine (Dukoral®).

    Biological: Oral cholera vaccine

  • Experimental
    Dukoral+Vivotif

    Oral typhoid fever and cholera vaccines (Vivotif® and Dukoral®) administered simultaneously.

    Biological: Oral typhoid fever vaccine · Biological: Oral cholera vaccine

Interventions

  • BiologicalOral typhoid fever vaccine

    Oral typhoid fever vaccine (Vivotif®) on Days 0, 2 and 4.

    Also known as: Vivotif®

  • BiologicalOral cholera vaccine

    Oral cholera vaccine (Dukoral®) on Days 0 and 7.

    Also known as: Dukoral®

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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)

    Time frame: Blood samples on Days 0-7 for all participants and Days 12-14 for participants in Dukoral and Dukoral+Vivotif arms.

Other outcomes

  1. 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)

    Time frame: Blood samples on Days 0 and 28 ± 3 for all participants.

07

Study locations

1 site
  • Meilahti Vaccine Research Center, Helsinki University Hospital
    Helsinki, 00290, Finland
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06104345
Lead sponsor
Helsinki University Central Hospital
Collaborators
University of Helsinki
Responsible party
Anu Kantele (MD, PhD, Professor of Infectious Diseases, Helsinki University Central Hospital) — Principal investigator
First posted
Oct 27, 2023
Start date
Oct 25, 2023
Primary completion
Jun 26, 2024
Completion
Jun 26, 2024
Last update
Dec 5, 2024

Study contacts

Anu Kantele, MD, PhD
principal investigator · Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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