Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Helsinki University Central Hospital
Updated on 8 November 2020

Summary

In a recent controlled study, the investigators explored cross-reactive immune responses against different Salmonella spp. in healthy volunteers immunized with either the oral (Vivotif ) or parenteral (Typherix) typhoid vaccines (ISRCTN68125331). In the present study immune responses will be studied in a group receiving both of these vaccines and in the previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization).

Description

Many Salmonella spp causing gastroenteritis share O antigen serotypes with Salmonella enteritidis subsp. enterica serovar Typhi (S.typhi) and could therefore be in 'reach' of the protective efficacy of the oral live typhoid fever vaccine Vivotif. Some of these Salmonellae are common causes of diarrhoea in travellers (0-30% of travellers diarrhea depending on the area). In a recent controlled study, the investigators showed that a cross-reactive immune response is elicited against different Salmonella spp. in healthy volunteers immunized with either the oral (Vivotif ) or parenteral (Typherix) typhoid vaccines (ISRCTN68125331).

In the present study immune responses will be studied in a group receiving both of these vaccines and in previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization; groups: Vivotif / Typherix / Vivotif + Typherix). The results are compared to those obtained after primary immunization.

Details
Condition healthy
Treatment Vivotif, Typherix
Clinical Study IdentifierNCT02121145
SponsorHelsinki University Central Hospital
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Primary groups: Vaccination against typhoid fever within 5 years before dosing
History of clinical typhoid fever, clinical paratyphoid A or B fever
Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
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 immune-modifying drugs within 6 months before the first dose of investigational vaccine; oral corticosteroids in dosages of 0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
Acute or chronic clinically significant gastrointestinal disease
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