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

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ClinicalTrials.gov Identifier: NCT02121145
Recruitment Status : Recruiting
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
Anu Kantele, Helsinki University Central Hospital

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).

Condition or disease Intervention/treatment Phase
Healthy Biological: Vivotif Biological: Typherix Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines Against Non-typhoid Salmonellae
Study Start Date : October 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vivotif + Typherix primary immunization
Vivotif + Typherix primary immunization
Biological: Vivotif
3 oral doses

Biological: Typherix
one intramuscular dose

Experimental: Vivotif booster
Volunteers previously immunized with Vivotif, now receiving a Vivotif secondary immunization
Biological: Vivotif
3 oral doses

Experimental: Typherix booster
Volunteers previously immunized with Typherix, now receiving a Typherix secondary immunization
Biological: Typherix
one intramuscular dose

Experimental: Vivotif + Typherix booster
Volunteers previously immunized with Vivotif and Typherix, now receiving Vivotif and Typherix as secondary immunization
Biological: Vivotif
3 oral doses

Biological: Typherix
one intramuscular dose




Primary Outcome Measures :
  1. Number of circulating plasmablasts specific to various Salmonella strains [ Time Frame: 7 days ]

    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 :
  1. Level of serum antibodies specific to various Salmonella strains [ Time Frame: 28 days ]

    To study whether cross-reactive serum immune response is similar

    • if the two vaccines are given simultaneously
    • after booster immunization than after primary immunization


Other Outcome Measures:
  1. Safety [ Time Frame: 28 days ]
    Record adverse effects of the vaccines used



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121145


Contacts
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Contact: Anu Kantele, Assoc. prof. +358503097640 anu.kantele@hus.fi
Contact: Sari H Pakkanen, MSc +358405166165 sari.pakkanen@helsinki.fi

Locations
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Finland
University of Helsinki, Haartman Institute Active, not recruiting
Helsinki, Finland, 00014
Helsinki University Central Hospital Active, not recruiting
Helsinki, Finland, 00029
Aava Medical Centre Recruiting
Helsinki, Finland, 00100
Contact: Tuija Oksanen, Nurse       tuija.oksanen@aava.fi   
Principal Investigator: Anu Kantele, Assoc. prof.         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Anu Kantele, Assoc. prof. Helsinki University Central Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anu Kantele, Associate professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02121145     History of Changes
Other Study ID Numbers: Ty21a-ASC
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Keywords provided by Anu Kantele, Helsinki University Central Hospital:
Vivotif
Typherix
Salmonella Typhi
non-typhoid Salmonella
Salmonella Paratyphi
enzyme-linked immunospot assay
Plasmablast
Additional relevant MeSH terms:
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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs