Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

NCT ID: NCT02121145

Last Updated: 2014-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vivotif + Typherix primary immunization

Vivotif + Typherix primary immunization

Group Type: EXPERIMENTAL

Vivotif

Intervention Type: BIOLOGICAL

3 oral doses

Typherix

Intervention Type: BIOLOGICAL

one intramuscular dose

Vivotif booster

Volunteers previously immunized with Vivotif, now receiving a Vivotif secondary immunization

Group Type: EXPERIMENTAL

Vivotif

Intervention Type: BIOLOGICAL

3 oral doses

Typherix booster

Volunteers previously immunized with Typherix, now receiving a Typherix secondary immunization

Group Type: EXPERIMENTAL

Typherix

Intervention Type: BIOLOGICAL

one intramuscular dose

Vivotif + Typherix booster

Volunteers previously immunized with Vivotif and Typherix, now receiving Vivotif and Typherix as secondary immunization

Group Type: EXPERIMENTAL

Vivotif

Intervention Type: BIOLOGICAL

3 oral doses

Typherix

Intervention Type: BIOLOGICAL

one intramuscular dose

Interventions

Vivotif

3 oral doses

Intervention Type: BIOLOGICAL

Typherix

one intramuscular dose

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anu Kantele

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anu Kantele, Assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

University of Helsinki, Haartman Institute

Helsinki, , Finland

Site Status: ACTIVE_NOT_RECRUITING

Helsinki University Central Hospital

Helsinki, , Finland

Site Status: ACTIVE_NOT_RECRUITING

Aava Medical Centre

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Anu Kantele, Assoc. prof.

Role: CONTACT

anu.kantele@hus.fi

+358503097640

Sari H Pakkanen, MSc

Role: CONTACT

sari.pakkanen@helsinki.fi

+358405166165

Facility Contacts

Tuija Oksanen, Nurse

Role: primary

tuija.oksanen@aava.fi

References

Pakkanen SH, Kantele JM, Savolainen LE, Rombo L, Kantele A. Specific and cross-reactive immune response to oral Salmonella Typhi Ty21a and parenteral Vi capsular polysaccharide typhoid vaccines administered concomitantly. Vaccine. 2015 Jan 9;33(3):451-8. doi: 10.1016/j.vaccine.2014.11.030. Epub 2014 Nov 26.

Reference Type: DERIVED

PMID: 25433216 (View on PubMed)

Other Identifiers

Ty21a-ASC

Identifier Type: -

Identifier Source: org_study_id