NCT02121145

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_4 healthy

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

6.2 years

First QC Date

December 30, 2013

Last Update Submit

April 19, 2014

Conditions

Healthy

Keywords

VivotifTypherixSalmonella Typhinon-typhoid SalmonellaSalmonella Paratyphienzyme-linked immunospot assayPlasmablast

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Level of serum antibodies specific to various Salmonella strains

    28 days

Other Outcomes (1)

  • Safety

    28 days

Study Arms (4)

Vivotif + Typherix primary immunization

EXPERIMENTAL

Vivotif + Typherix primary immunization

Biological: VivotifBiological: Typherix

Vivotif booster

EXPERIMENTAL

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

Biological: Vivotif

Typherix booster

EXPERIMENTAL

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

Biological: Typherix

Vivotif + Typherix booster

EXPERIMENTAL

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

Biological: VivotifBiological: Typherix

Interventions

VivotifBIOLOGICAL

3 oral doses

Vivotif + Typherix boosterVivotif + Typherix primary immunizationVivotif booster
TypherixBIOLOGICAL

one intramuscular dose

Typherix boosterVivotif + Typherix boosterVivotif + Typherix primary immunization

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Helsinki, Haartman Institute

Helsinki, 00014, Finland

ACTIVE NOT RECRUITING

Helsinki University Central Hospital

Helsinki, 00029, Finland

ACTIVE NOT RECRUITING

Aava Medical Centre

Helsinki, 00100, Finland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25433216DERIVED

MeSH Terms

Interventions

Ty21a typhoid vaccine

Study Officials

  • Anu Kantele, Assoc. prof.

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anu Kantele, Assoc. prof.

CONTACT

+358503097640anu.kantele@hus.fi

Sari H Pakkanen, MSc

CONTACT

+358405166165sari.pakkanen@helsinki.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 30, 2013

First Posted

April 23, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

FI(3)