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Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines (Ty21a-ASC)

Primary Purpose

Healthy

Status

Unknown status

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

Vivotif

Typherix

About this trial

This is an interventional prevention trial for Healthy focused on measuring Vivotif, Typherix, Salmonella Typhi, non-typhoid Salmonella, Salmonella Paratyphi, enzyme-linked immunospot assay, Plasmablast

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Helsinki, Haartman Institute
Helsinki University Central Hospital
Aava Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Vivotif + Typherix primary immunization

Vivotif booster

Typherix booster

Vivotif + Typherix booster

Arm Description

Vivotif + Typherix primary immunization

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02121145

First Posted

December 30, 2013

Last Updated

April 19, 2014

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02121145

Brief Title

Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

Acronym

Ty21a-ASC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2013 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Vivotif, Typherix, Salmonella Typhi, non-typhoid Salmonella, Salmonella Paratyphi, enzyme-linked immunospot assay, Plasmablast

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vivotif + Typherix primary immunization

Arm Type

Experimental

Arm Description

Vivotif + Typherix primary immunization

Arm Title

Vivotif booster

Arm Type

Experimental

Arm Description

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

Arm Title

Typherix booster

Arm Type

Experimental

Arm Description

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

Arm Title

Vivotif + Typherix booster

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Vivotif

Intervention Description

3 oral doses

Intervention Type

Biological

Intervention Name(s)

Typherix

Intervention Description

one intramuscular dose

Primary Outcome Measure Information:

Title

Number of circulating plasmablasts specific to various Salmonella strains

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Level of serum antibodies specific to various Salmonella strains

Description

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

Time Frame

28 days

Other Pre-specified Outcome Measures:

Title

Safety

Description

Record adverse effects of the vaccines used

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anu Kantele, Assoc. prof.

Phone

+358503097640

anu.kantele@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Sari H Pakkanen, MSc

Phone

+358405166165

sari.pakkanen@helsinki.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anu Kantele, Assoc. prof.

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Helsinki, Haartman Institute

City

Helsinki

ZIP/Postal Code

00014

Country

Finland

Individual Site Status

Active, not recruiting

Facility Name

Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Individual Site Status

Active, not recruiting

Facility Name

Aava Medical Centre

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tuija Oksanen, Nurse

tuija.oksanen@aava.fi

First Name & Middle Initial & Last Name & Degree

Anu Kantele, Assoc. prof.

12. IPD Sharing Statement

Citations:

PubMed Identifier

25433216

Citation

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.

Results Reference

derived

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Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

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