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

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

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).

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Anu Kantele, Assoc. prof.; +358503097640; anu.kantele@hus.fi

Contact: Sari H Pakkanen, MSc; +358405166165; sari.pakkanen@helsinki.fi

Locations

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

• Principal Investigator: Anu Kantele, Assoc. prof.; Helsinki University Central Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Anu Kantele, Associate professor, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02121145
• Other Study ID Numbers: Ty21a-ASC
• First Posted: April 23, 2014
• 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:

Typhoid Fever; Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections