Prophylaxis for healthy adult volunteers. Phase IV comparison study of typhoid fever vaccines.
Conditions
Interventions
Trade Name: Vivotif
Product Name: Vivotif
Pharmaceutical Form: Capsule*
INN or Proposed INN: Vaccinum febris typhoidis vivum perorale (stirpe Ty21a)
Concentration type: not less then
Concentration num
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Vaccination against typhoid fever within 5 years before dosing. 2. History of clinical typhoid fever, clinical paratyphoid A or B fever. 3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study 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 are 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 enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C). 10. Alcohol or drug abuse 11. Suspected non-compliance 12. Use of any investigational drug or any investigational 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, relative or spouse of the investigator 15. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of cross-reactive antibodies against O9 and/or O12 somatic antigen containing Salmonella spp after immunisation with Vivotif (in comparison to Typherix®) ;Primary end point(s): • Measurement of specific IgA -, IgG- and IgM-secreting antibody cells specific to / cross-reactive with the different Salmonella serovars in peripheral blood using ELISPOT;Secondary Objective: - To evaluate the homing potentials of circulating vaccine antigen-specific antibody- secreting cells towards gut mucosa, systemic immune system and cutaneous sites after immunisation with Vivotif® (in comparison to Typherix®) - To evaluate the immunogenicity of the typhoid fever vaccine Vivotif® (in comparison to Typherix®) in terms of the agglutination (Widal) and Salmonella-specific antibody response in serum, saliva and tears (ELISA) - To analyse the cell-mediated immune response to S.typhi and selected Salmonella spp (prolifieration assay and IFN-gamma production) | — |
Countries
Finland
Outcome results
None listed