Immunity elicited by concomitant administration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines

Phase 1

• Conditions: Healthy volunteers; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-003474-16-FI
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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. Abstinence is acceptable.
5. Available for all visits scheduled in this study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 immune-modifying 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the immune response of concomitant administration of the oral typhoid vaccine Vivotif and oral cholera vaccine Dukoral as compared to dosing separately.;Secondary Objective: Not applicable;Primary end point(s): Measurement of specific IgA -, IgG- and IgM-secreting antibody cells specific to S. Typhi, Cholera (whole cell and CTB-toxin) and ETEC (whole cell) in peripheral blood using ELISPOT;Timepoint(s) of evaluation of this end point: 0, 5 and 7 days after immunization in Vivotif group; <br>0, 5, 7, 12, 14 days after first dose of Dukoral in groups receiving the <br>two Dukoral doses (group Vivotif+ Dukoral and group Dukoral)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Anti-Salmonella and anti-cholera toxin antibodies in serum and ALS (antibodies in lymphocyte supernatant) samples (ELISA).;Timepoint(s) of evaluation of this end point: 0 and 28 days after immunization.