Typhoid FeverPhase 1NCT03956524
Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
A Phase 1 study testing EuTCV, Typbar-TCV™ and Typhim Vi® in people with Typhoid Fever, run by EuBiologics Co.,Ltd at 1 site in Philippines.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- EuTCV, Typbar-TCV™ and Typhim Vi®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePhilippines
- Study dates
- 16 Mar 2019to 31 Aug 2019
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged between and including 18 and 45 years at time of Visit 1
- Subjects willing to give written informed consent to participate in the trial
- Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
Who cannot join
- Subjects unwilling to give his/her consent to participate in the trial
- Subjects who have received Typhoid containing vaccines
- Subjects who have past history of Typhoid
- Subjects already immunized with any licensed vaccine within 4 weeks
- Subjects with known hypersensitivity to any component of the study vaccine
- Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
Show all 12Show fewer
- Subjects with any abnormality or chronic disease
- Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
- Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
- Subjects who have known history of immune function disorders
- Subjects who have known history of administration of blood or blood-derived products
- Subjects who have history of alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
Philippines1 site
De La Salle Health Sciences Institute
Dasmariñas, Cavite, 4114
About this study
Official title: An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
- Conditions
- Typhoid Fever
- Being tested
- EuTCV, Typbar-TCV™, Typhim Vi®
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuTCVBiological
Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
Typbar-TCV™Biological
Single 0.5 mL dose of TCV of Bharat Biotech
Typhim Vi®Biological
Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Single dose of EuTCV will be administered intramuscularly Receives: Biological: EuTCV |
| Comparator group 1 | Active comparator | Single dose of Typbar-TCV™ will be administered intramuscularly Receives: Biological: Typbar-TCV™ |
| Comparator group 2 | Active comparator | Single dose of Typhim Vi® will be administered intramuscularly Receives: Biological: Typhim Vi® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic solicited adverse events
Measured: Day 7
Unsolicited adverse events
Measured: up to 6 weeks
Serious adverse events
Measured: up to 6 weeks
Secondary outcomes (1)
Proportion of subjects with seroconversion
Defined as a 4-fold or more rise in anti-Vi antibody titers
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start16 Mar 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
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 Typhoid FeverStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956524
- Sponsor's protocol ID
- UTCV_101
- Status last verified
- Dec 2019
- First submitted
- 15 May 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10.
PubMed 33849723
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
- ClinicalTrials.gov ID
- NCT03956524
- Acronym / sponsor ID
- UTCV_101
- Conditions
- Typhoid Fever
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 20 May 2019 (actual)
- 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.
The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: EuTCVSingle dose of EuTCV will be administered intramuscularly |
| Comparator group 1 | Active comparator | Biological: Typbar-TCV™Single dose of Typbar-TCV™ will be administered intramuscularly |
| Comparator group 2 | Active comparator | Biological: Typhim Vi®Single dose of Typhim Vi® will be administered intramuscularly |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects aged between and including 18 and 45 years at time of Visit 1
- Subjects willing to give written informed consent to participate in the trial
- Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
Key exclusion criteria (12 listed)
- Subjects unwilling to give his/her consent to participate in the trial
- Subjects who have received Typhoid containing vaccines
- Subjects who have past history of Typhoid
- Subjects already immunized with any licensed vaccine within 4 weeks
- Subjects with known hypersensitivity to any component of the study vaccine
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 |
|---|---|---|
| EuTCVSingle 0.5 mL dose of TCV of EuBiologics co., Ltd. | Biological | Test group |
| Typbar-TCV™Single 0.5 mL dose of TCV of Bharat Biotech | Biological | Comparator group 1 |
| Typhim Vi®Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur | Biological | Comparator group 2 |
Primary outcome
Local and systemic solicited adverse events
Time frame: Day 7
Unsolicited adverse events
Time frame: up to 6 weeks
Serious adverse events
Time frame: up to 6 weeks
1 secondary outcome
Proportion of subjects with seroconversion
Time frame: Baseline to Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 33849723Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EuTCV, Typbar-TCV™ and Typhim Vi® in people with Typhoid Fever, run by EuBiologics Co.,Ltd at 1 site in Philippines.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local and systemic solicited adverse events (time frame: Day 7). The study lists 3 primary outcomes in all. 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 NCT03956524, 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 9 Dec 2019.