TyphoidPhase 1NCT02645032
Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine
A Phase 1 study testing Vi-DT, Typhim Vi® and VAXIGRIP® in people with Typhoid, run by International Vaccine Institute.
Trial summary
This is a Phase I, Randomized, observer-blinded, age de-escalating study. The study objectives are: 1. To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks. 2. To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks. 3. Read more about this study
- Who is it for?
- Ages 2 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid
- What is being tested?
- Vi-DT, Typhim Vi® and VAXIGRIP®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2016to 9 Feb 2017
- 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 2 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy male and female individual 2-45 years of age
- Participants/Parents who have voluntarily given informed consent and/or assent.
- Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study
Who cannot join
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious diseases or fever (axillary temperature > 38°C), with in three days prior to enrollment and vaccination.
- Known history of allergy to vaccines or other medications
- Known history of allergy to egg, chiken protein, neomycin and formaldehyde.
- History of uncontrolled coagulopathy or blood disorders
- Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (> 20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
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- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the trial objectives
- Pregnancy \& Lactation (female adults)
- Female with child-bearing potential during the study period. i.e., sexually active and not practicing effective acceptable contraceptive method
- Individuals who have previously received any vaccines against typhoid fever
- Individuals already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (day 0) and expected to receive other licensed vaccines within 60 days following the first dose (day 0), except for tetanus toxoid vaccine
- Individuals who have a previously ascertained or suspected disease caused by S. typhi.
- Individuals who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
- History of alcohol or substance abuse
- Subject planning to move from the study area before the end of study period
About this study
Official title: A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
- To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.
Read the detailed description
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
- Conditions
- Typhoid
- Being tested
- Vi-DT, Typhim Vi®, VAXIGRIP®
- Keywords
- Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicuty
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vi-DTBiological
Also called Vi-DT typhoid conjugate vaccine
Manufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
Typhim Vi®Biological
Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial
VAXIGRIP®Biological
Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose)
*Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28). Receives: Biological: Vi-DT |
| Comparator group | Active comparator | Biological/Vaccine:
One dose of Typhim Vi® will be administrated intramuscularly at 1st dose (Day 0).
One dose of VAXIGRIP® will be administrated intramuscularly at 2nd dose (Day 28). Receives: Biological: Typhim Vi®; Biological: VAXIGRIP® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events
Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)
Measured: 4 weeks post first and second vaccination
Secondary outcomes (2)
Proportion of participants with sero-conversion
Defined as a four-fold rise in anti-Vi antibody titers compared to baseline measured by anti-Vi IgG ELISA and Serum Bactericidal Assay
Measured: 4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide
Geometric Mean Titers (GMT)
Measurement of the Geometric Mean Titers (GMT) following 4 weeks post first and second injections of Vi-DT and one injection of Vi-polysaccharide vaccine
Measured: 4 weeks post first and second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study start19 May 2016
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
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 TyphoidStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Maria Rosario Capeding, MD, Principal investigator, Research Institution for Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645032
- Sponsor's protocol ID
- IVI T001
- Status last verified
- Feb 2018
- First submitted
- 22 Dec 2015
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo SK, Chon Y, Kothari S, Yang SY, Ham DS, Ryu JH, Hwang HS, Mun JH, Lynch JA, Kim JH, Kim H, Excler JL, Sahastrabuddhe S. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine. 2018 Jun 18;36(26):3794-3801. doi: 10.1016/j.vaccine.2018.05.038.
PubMed 29776750
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blinded, Phase I Study to Assess the Safety and Immunogenicity of Vi-DT Conjugate Vaccine Compared to Vi-Polysaccharide (Typhim Vi®, Sanofi Pasteur) Typhoid Vaccine in Healthy Filipino Adults and Children
- ClinicalTrials.gov ID
- NCT02645032
- Acronym / sponsor ID
- IVI T001
- Conditions
- Typhoid
- Keywords
- Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicuty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- SK Chemicals Co., Ltd.
- Study start
- 19 May 2016 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 1 Jan 2016 (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.
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
- To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.
Detailed description
This study will be carried out in healthy adults and children at a single site. Subjects will be stratified according to age.
The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical history, physical examination and lab investigations. Collect blood for safety and immunogenicity assessments.
Visit 2 (day 0): Enroll, randomize and administer first dose of vaccine to eligible participants
Visit 3 (day 3): Assess participant safety by medical history and physical examination
Visit 4 (day 7): Record solicited adverse reaction 7 days post vaccination, and collect blood for safety lab assessments.
Visit 5 (day 28): Assess participant safety, collect blood for immunogenicity assessments, and administer second vaccine dose
Visit 6 (day 31): Participants safety will be assessed by medical history and physical examination
Visit 7 (day 35): Record solicited adverse reaction 7 days post second vaccination.
Visit 8 (day 56): Collect blood for immunogenicity assessments, assess participant safety, and fill in study completion form in the absence of any safety concern.
This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Biological: Vi-DTTwo doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28). |
| Comparator group | Active comparator | Biological: Typhim Vi®, Biological: VAXIGRIP®Biological/Vaccine: One dose of Typhim Vi® will be administrated intramuscularly at 1st dose (Day 0). One dose of VAXIGRIP® will be administrated intramuscularly at 2nd dose (Day 28). |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy male and female individual 2-45 years of age
- Participants/Parents who have voluntarily given informed consent and/or assent.
- Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study
Key exclusion criteria (15 listed)
- Participants concomitantly enrolled or scheduled to be enrolled in another trial
- Acute illness, in particular infectious diseases or fever (axillary temperature > 38°C), with in three days prior to enrollment and vaccination.
- Known history of allergy to vaccines or other medications
- Known history of allergy to egg, chiken protein, neomycin and formaldehyde.
- History of uncontrolled coagulopathy or blood disorders
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-DTAlso: Vi-DT typhoid conjugate vaccineManufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial | Biological | Test group |
| Typhim Vi®Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial | Biological | Comparator group |
| VAXIGRIP®Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose) *Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort. | Biological | Comparator group |
Primary outcome
Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events
Time frame: 4 weeks post first and second vaccination
Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)
2 secondary outcomes
Proportion of participants with sero-conversion
Time frame: 4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide
Geometric Mean Titers (GMT)
Time frame: 4 weeks post first and second vaccination
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 28 Apr 2020.
- Derived from this study: PubMed 29776750Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo SK, Chon Y, Kothari S, Yang SY, Ham DS, Ryu JH, Hwang HS, Mun JH, Lynch JA, Kim JH, Kim H, Excler JL, Sahastrabuddhe S. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine. 2018 Jun 18;36(26):3794-3801. doi: 10.1016/j.vaccine.2018.05.038.
- Final ResultLink provided by the sponsor.
- 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.
Maria Rosario Capeding, MD principal investigator
Research Institution for Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vi-DT, Typhim Vi® and VAXIGRIP® in people with Typhoid, run by International Vaccine Institute.
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 15 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events (time frame: 4 weeks post first and second vaccination). 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 NCT02645032, 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 28 Apr 2020.