Cross-reactive immunity elicited by oral and parenteral typhoid vaccines against non-typhoid Salmonellae

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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