HealthyPhase 4Ty21a-ASCNCT02121145
Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines
A Phase 4 study testing Vivotif and Typherix in people with Healthy, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vivotif and Typherix
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFinland
- Study dates
- Oct 2013to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Finland3 sites, 1 recruiting
- Active, not recruiting
University of Helsinki, Haartman Institute
Helsinki, 00014
- Active, not recruiting
Helsinki University Central Hospital
Helsinki, 00029
- Recruiting
Aava Medical Centre
Helsinki, 00100
Tuija Oksanen, Nurse, tuija.oksanen@aava.fi
Anu Kantele, Assoc. prof.
About this study
Official title: Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines Against Non-typhoid Salmonellae
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).
Read the 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.
- Conditions
- Healthy
- Being tested
- Vivotif, Typherix
- Keywords
- Vivotif, Typherix, Salmonella Typhi, non-typhoid Salmonella, Salmonella Paratyphi, enzyme-linked immunospot assay, Plasmablast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivotifBiological
3 oral doses
TypherixBiological
one intramuscular dose
| Study group | Role | What they receive |
|---|---|---|
| Vivotif + Typherix primary immunization | Experimental | Vivotif + Typherix primary immunization Receives: Biological: Vivotif; Biological: Typherix |
| Vivotif booster | Experimental | Volunteers previously immunized with Vivotif, now receiving a Vivotif secondary immunization Receives: Biological: Vivotif |
| Typherix booster | Experimental | Volunteers previously immunized with Typherix, now receiving a Typherix secondary immunization Receives: Biological: Typherix |
| Vivotif + Typherix booster | Experimental | Volunteers previously immunized with Vivotif and Typherix, now receiving Vivotif and Typherix as secondary immunization Receives: Biological: Vivotif; Biological: Typherix |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anu Kantele, Helsinki University Central Hospital
- Investigators
- Anu Kantele, Assoc. prof., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121145
- Sponsor's protocol ID
- Ty21a-ASC
- Acronym
- Ty21a-ASC
- Status last verified
- Apr 2014
- First submitted
- 30 Dec 2013
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25433216
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines Against Non-typhoid Salmonellae
- ClinicalTrials.gov ID
- NCT02121145
- Acronym / sponsor ID
- Ty21a-ASC / Ty21a-ASC
- Conditions
- Healthy
- Keywords
- Vivotif, Typherix, Salmonella Typhi, non-typhoid Salmonella, Salmonella Paratyphi, enzyme-linked immunospot assay, Plasmablast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vivotif + Typherix primary immunization | Experimental | Biological: Vivotif, Biological: TypherixVivotif + Typherix primary immunization |
| Vivotif booster | Experimental | Biological: VivotifVolunteers previously immunized with Vivotif, now receiving a Vivotif secondary immunization |
| Typherix booster | Experimental | Biological: TypherixVolunteers previously immunized with Typherix, now receiving a Typherix secondary immunization |
| Vivotif + Typherix booster | Experimental | Biological: Vivotif, Biological: TypherixVolunteers previously immunized with Vivotif and Typherix, now receiving Vivotif and Typherix as secondary immunization |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivotif3 oral doses | Biological | Vivotif + Typherix booster, Vivotif + Typherix primary immunization, Vivotif booster |
| Typherixone intramuscular dose | Biological | Typherix booster, Vivotif + Typherix booster, Vivotif + Typherix primary immunization |
Primary outcome
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
1 secondary outcome
Level of serum antibodies specific to various Salmonella strains
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Derived from this study: PubMed 25433216Pakkanen 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Kantele, Assoc. prof. principal investigator
Helsinki University Central Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vivotif and Typherix in people with Healthy, run by Helsinki University Central Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anu Kantele, Assoc. prof. (+358503097640, anu.kantele@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating plasmablasts specific to various Salmonella strains (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.