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

NCT06104345 | Completed Phase 4

• 1 other identifier: Dukoral+Vivotif
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Vaccine-Preventable Diseases; Typhoid Fever; Cholera

Keywords

Immunogenicity; Coadministration; ELISPOT; B cells; Oral vaccination; Salmonella Typhi; Vibrio cholerae

Outcome Measures

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).

  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.

  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.

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

Study Arms (3)

Vivotif

ACTIVE COMPARATOR

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

Biological: Oral typhoid fever vaccine

Dukoral

ACTIVE COMPARATOR

Two oral doses of cholera vaccine (Dukoral®).

Biological: Oral cholera vaccine

Dukoral+Vivotif

EXPERIMENTAL

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

Biological: Oral typhoid fever vaccine; Biological: Oral cholera vaccine

Interventions

Oral typhoid fever vaccine BIOLOGICAL

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

Also known as: Vivotif®

Dukoral+Vivotif; Vivotif

Oral cholera vaccine BIOLOGICAL

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

Also known as: Dukoral®

Dukoral; Dukoral+Vivotif

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Meilahti Vaccine Research Center, Helsinki University Hospital

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases; Typhoid Fever; Cholera

Interventions

Ty21a typhoid vaccine; Cholera Vaccines; Dukoral

Condition Hierarchy (Ancestors)

Infections; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vibrio Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Anu Kantele, MD, PhD

  Meilahti Vaccine Research Center, MeVac, Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of Infectious Diseases

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: October 25, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)