Comparison of immune responses elicited by oral and parenteral typhoid fever vaccines

Completed

• Conditions: Prophylaxis of typhoid fever; Infections and Infestations; Typhoid and paratyphoid fevers

• Registration Number: ISRCTN68125331
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male or female subjects aged 18 to 65 years
2. Free of obvious health problems
3. Written informed consent

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. Current intake of antibiotics or end of antibiotic therapy less than 8 days before first investigative medicinal product (IMP) administration
4. Standard exclusion criteria (allergic to vaccine components, acute disease, immunosuppressed, serious chronic illness, pregancy or lactation, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of specific IgA- IgG- and IgM-secreting antibody cells in peripheral blood using ELISPOT, measured at day 7.

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the expression of various homing receptors on antigen-specific antibody-secreting cells by separating the PBMCs with immunomagnetic cell sorting according to their HR expressions and by investigating specific ASC in the resulting subpopulations<br>2. Antibody analyses from serum (Widal test/ELISA)<br>3. Cell-mediated immune response<br><br>Measured at week 1 and 4.