VaccinePhase 2/3NCT04741828
Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian
A Phase 2/3 study testing Vi-DT Typhoid Conjugate Vaccine in people with Vaccine, run by PT Bio Farma at 2 sites in Indonesia.
Trial summary
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization. Read more about this study
- Who is it for?
- Ages 6 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine
- What is being tested?
- Vi-DT Typhoid Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 2 sitesIndonesia
- Study dates
- 3 May 2021to 30 Dec 2024
- Phase
- Phase 2/3
- 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 6 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy.
- Subject who completed the phase II Vi-DT study (Typhoid 0218)
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
- Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.
Who cannot join
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
- Known history of allergy to any component of the vaccines.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
Read the detailed description
This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.
- Conditions
- Vaccine
- Being tested
- Vi-DT Typhoid Conjugate Vaccine
- Keywords
- Vi-DT Typhoid Conjugate Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DT Typhoid Conjugate VaccineDrug
Typhoid Conjugate Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vi-DT Typhoid Conjugate Vaccine | Experimental | Participants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly. Receives: Drug: Vi-DT Typhoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
Percentage of adults, adolescent, children and infants with seroconversion defined as >= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.
Measured: 2 years + 2 months after primary dose
Secondary outcomes (4)
To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.
Percentage of subject aged 6-23 months old at primary dose with seroconversion defined as >= 4 fold in antibody titer 28 days after booster dose compared to pre booster dose.
Measured: 28 days (-4/+14D)
To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.
Percentage of subject with at least one adverse event, solicited or unsolicited, within 30 minutes, 72hours, 7 days and 28 days after booster dose.
Measured: 28 days (-4/+14D)
To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.
Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to baseline.
Measured: 5 years
To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.
Percentage of adults, adolescents and children with seroconversion defined as ≥ 4-fold in antibody titer of anti-Vi IgG 3,4 and 5 years after vaccination compared to before booster.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start3 May 2021
- Primary completion28 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Responsible party
- Sponsor
- Investigators
- Bernie E Medise, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741828
- Sponsor's protocol ID
- Typhoid 0220
- Status last verified
- Jun 2025
- First submitted
- 27 Jan 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence and Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines in Indonesian Adults, Adolescent, Children and Infants
- ClinicalTrials.gov ID
- NCT04741828
- Acronym / sponsor ID
- Typhoid 0220
- Conditions
- Vaccine
- Keywords
- Vi-DT Typhoid Conjugate Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia
- Study start
- 3 May 2021 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Feb 2021 (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.
Vi-DT Typhoid vaccine is a novel vaccine. This study will be done to know the long-term protection and persistent antibody by measured the antibody titer after 2,3,4 and 5 years after immunization.
Detailed description
This study will be done to know the long-term protection and persistent antibody, by measured the antibody titer after 2,3,4 and 5 years after immunization.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One dose Vi-DT vaccine in clinical trial subjects which is received primary dose at 6-23 months old.
| Arm | Type | Receives |
|---|---|---|
| Vi-DT Typhoid Conjugate Vaccine | Experimental | Drug: Vi-DT Typhoid Conjugate VaccineParticipants receive 1 dose (0.5ml) Vi-DT Typhoid Conjugate Vaccine, intramuscularly. |
Who may qualify
- Ages
- 6 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy.
- Subject who completed the phase II Vi-DT study (Typhoid 0218)
- Subjects/Parents have been informed properly regarding the study and signed the informed consent form.
- Subject/parents/legal guardians will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (5 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5oC).
- Known history of allergy to any component of the vaccines.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Any abnormality or chronic disease which according to the investigator might be compromised by the vaccination and/or interfere with the assessment of the trial objectives.
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 |
|---|---|---|
| Vi-DT Typhoid Conjugate VaccineTyphoid Conjugate Vaccine | Drug | Vi-DT Typhoid Conjugate Vaccine |
Primary outcome
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants
Time frame: 2 years + 2 months after primary dose
Percentage of adults, adolescent, children and infants with seroconversion defined as >= 4 fold in antibody titer of anti Vi IgG 2 years after vaccination compared to baseline.
4 secondary outcomes
To evaluate immunogenicity one month after booster dose of Vi-DT in subject aged 6-23 months when receiving the primary dose.
Time frame: 28 days (-4/+14D)
To assess the safety following booster vaccination in subject aged 6-23 months when receiving the primary dose.
Time frame: 28 days (-4/+14D)
To evaluate antibody persistence 3, 4 and 5 years after vaccination with one dose of Vi-DT in adults, adolescents, and children groups.
Time frame: 5 years
To evaluate antibody persistence 1, 2 and 3 years after booster vaccination in subject aged 6-23 months when receiving the primary dose.
Time frame: 3 years
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 3 Jun 2025.
- 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.
Bernie E Medise, MD principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vi-DT Typhoid Conjugate Vaccine in people with Vaccine, run by PT Bio Farma at 2 sites in Indonesia.
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 4 inclusion and 5 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 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To evaluate antibody persistence 2 years after vaccination with one dose of Vi-DT in adults, adolescent, children and infants (time frame: 2 years + 2 months after primary dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.