Are you healthy and looking to help advance medical science?

You may be eligible to participate in a healthy clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a healthy clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Healthy Clinical Trial

NCT02121145 | Phase 4 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a healthy clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a healthy clinical study, and could be compensated for your time.

Recruiting

Male & Female

18 - 64

Years old

This study is looking to recruit 100 Participants

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).

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Details for the study

Brief Title

Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

Official Title

Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines Against Non-typhoid Salmonellae

Brief 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).

Detailed 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.

Treatments and/or Procedures

Vivotif

3 oral doses

Typherix

one intramuscular dose

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Number of circulating plasmablasts specific to various Salmonella strains

To study whether cross-reactive immune response is similar if the two vaccines are given simultaneously after booster immunization than after primary immunization

7 days

Secondary

Level of serum antibodies specific to various Salmonella strains

To study whether cross-reactive serum immune response is similar if the two vaccines are given simultaneously after booster immunization than after primary immunization

28 days

Other

Safety

Record adverse effects of the vaccines used

28 days

Study 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.

Exclusion Criteria:

  1. Primary groups: 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 investigational
     vaccine; 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