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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivotif + Typherix primary immunization | Experimental | Vivotif + Typherix primary immunization |
|
| Vivotif booster | Experimental | Volunteers previously immunized with Vivotif, now receiving a Vivotif secondary immunization |
|
| Typherix booster | Experimental | Volunteers previously immunized with Typherix, now receiving a Typherix secondary immunization |
|
| Vivotif + Typherix booster | Experimental | Volunteers previously immunized with Vivotif and Typherix, now receiving Vivotif and Typherix as secondary immunization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivotif | Biological | 3 oral doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of circulating plasmablasts specific to various Salmonella strains | To study whether cross-reactive immune response is similar
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Level of serum antibodies specific to various Salmonella strains | To study whether cross-reactive serum immune response is similar
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Record adverse effects of the vaccines used | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anu Kantele, Assoc. prof. | Contact | +358503097640 | anu.kantele@hus.fi | |
| Sari H Pakkanen, MSc | Contact | +358405166165 | sari.pakkanen@helsinki.fi |
| Name | Affiliation | Role |
|---|---|---|
| Anu Kantele, Assoc. prof. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki, Haartman Institute | Active, not recruiting | Helsinki | 00014 | Finland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25433216 | Derived | 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. |
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| ID | Term |
|---|---|
| C072772 | Ty21a typhoid vaccine |
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| Typherix | Biological | one intramuscular dose |
|
| Helsinki University Central Hospital |
| Active, not recruiting |
| Helsinki |
| 00029 |
| Finland |
| Aava Medical Centre | Recruiting | Helsinki | 00100 | Finland |
|