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Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine
This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose.
The study objectives are:
I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT)
II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Typhoid | Biological: Test Vaccine Vi-DT Typhoid conjugate Biological: Control Vaccine Typbar TCV® | Phase 3 |
Subjects will be stratified according to age. The study procedure is as follows:
Visit 1 (day-1 to -7): Screen participants by medical/medications history, physical examination, Vital signs, Urine pregnancy test (UPT)
Visit 2 (day 0): Enroll, randomize and administer vaccine to eligible participants and assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments.
Visit 3 (day 7): Check solicited adverse reaction 7 days post vaccination and Assess participant safety by physical examination and Vital signs
Visit 4 (day 28): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments
Visit 5 (day 84): Assess participant safety by physical examination and Vital signs
Visit 6 (day 168): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments, 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.
For retention: After vaccination, field health worker/designee will contact participant every day till Day 7 by physical visit or by phone call. Follow-up reminder calls will be done very frequently as per discretion of study staff until 24 weeks for all participant to assess participant safety.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants age 6 months to 45 years |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | This study is observer blind:
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| Primary Purpose: | Prevention |
| Official Title: | A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants. |
| Actual Study Start Date : | November 15, 2019 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | January 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Test group A: Lot 1 Vi-DT (typhoid conjugate vaccine)
One dose of Vi-DT (typhoid conjugate vaccine) Lot 1 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months. |
Biological: Test Vaccine Vi-DT Typhoid conjugate
Other Name: Vi-DT Typhoid conjugate vaccine
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Experimental: Test group B: Lot 2 Vi-DT (typhoid conjugate vaccine)
One dose of Vi-DT (typhoid conjugate vaccine) Lot 2 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months. |
Biological: Test Vaccine Vi-DT Typhoid conjugate
Other Name: Vi-DT Typhoid conjugate vaccine
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Experimental: Test group C: Lot 3 Vi-DT (typhoid conjugate vaccine)
One dose of Vi-DT (typhoid conjugate vaccine) Lot 3 will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months. |
Biological: Test Vaccine Vi-DT Typhoid conjugate
Other Name: Vi-DT Typhoid conjugate vaccine
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Active Comparator: Test group D: Typbar TCV
One dose of Typbar TCV will be administrated intramuscularly at Enrollment visit (Day 0). MR for age group at 9-15 months. |
Biological: Control Vaccine Typbar TCV®
Other Name: Typbar TCV®
|
- Seroconversion rate1 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0) ]Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
- Geometric Mean Titers (GMT)1 [ Time Frame: 4 weeks after vaccination of Vi-DT ]Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT
- Geometric Mean Titers (GMT) 2 [ Time Frame: 4 weeks and 24 weeks after vaccination of Vi-DT(pooled)/ Typbar TCV® ]Measurement of the Geometric Mean Titers (GMT) following 4 weeks (28 days) and 24 weeks(168 days) after vaccination of Vi-DT (pooled)/ Typbar TCV®
- Seroconversion rate 2 [ Time Frame: 24 weeks (168 days) after vaccination of Vi-DT(pooled)/ Typbar TCV® compared to baseline (D0). ]Defined as a 4-fold increase of serum anti-Vi IgG antibody titer
- Seroconversion rate 3 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled) ]Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers after vaccination of three lots of Vi-DT.
- Seroconversion rate 4 [ Time Frame: 4 weeks (28 days) after vaccination of Vi-DT(pooled) ]Definded as a Seroconversion rates of anti-Vi IgG ELISA antibody titers at 4 weeks (28 days) after vaccination of three lots of Vi-DT in each age strata
- Seroconversion rate 5 [ Time Frame: 4 weeks (28 days) after vaccination of MR compared to baseline (D0) ]Definded as IgG ELISA antibody titers for Measles (M), and Rubella (R) following single dose of MR a vaccine at baseline D0 and 4 weeks
- Safety endpoints for solicited adverse events (reactogenicity) [ Time Frame: 7days after vaccination of Vi-DT(pooled)/ Typbar TCV® ]Proportion of participants with local and systemic solicited adverse events
| Ages Eligible for Study: | 6 Months to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy participants 6 months to 45 years of age at enrollment
- Participants/Parents/LAR who have voluntarily given informed consent/assent
- Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
Exclusion Criteria:
- Child with a congenital abnormality
- Subject concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
- Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
- Receipt of blood or blood-derived products in the past 3 months
- Subject with a previously ascertained or suspected disease caused by S. Typhi
- Subject who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. Typhi
- Individual who has previously received a typhoid vaccine
- Subject who has received or is expected to receive other vaccines from 1 month prior to IP vaccination to Visit 4 (approx.1 month post IP) except PVC booster as per EPI schedule
- Known history or allergy to vaccines or other medications
- History of uncontrolled coagulopathy or blood disorders
- Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives
- Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period
- Participants/Parents/LAR planning to move from the study area before the end of study period
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As per Investigator's medical judgement individuals could be excluded from the study inspite of meeting all inclusion/exclusion criteria mentioned above
Temporary Contraindication
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Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination.
- Urine pregnancy test (UPT) will be performed in all married females prior to injection
| Nepal | |
| Nepalgunj medical college | |
| Banke, City- Nepalgunj, Nepal | |
| B.P.Koirala Institute of Health Sciences | |
| Rautahat, Dharan, Nepal | |
| Dhulikhel Hospital | |
| Kavre, Dhulikhel, Nepal | |
| Kanti Children's Hospital | |
| Kathmandu, Sukedhara, Nepal, 44600 | |
| Principal Investigator: | Ganesh Kumar Rai, MD | Kanti Children's Hospital |
| Tracking Information | |||||
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| First Submitted Date ICMJE | April 26, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | April 22, 2020 | ||||
| Actual Study Start Date ICMJE | November 15, 2019 | ||||
| Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine | ||||
| Official Title ICMJE | A Phase III Multicenter, Observer-Blinded, Randomized, Active Controlled, Immune Non-inferiority and Safety Study of Vi-DT Vaccine Compared to Typbar TCV® in Healthy 6 Months-45 Years Aged Nepalese Participants. | ||||
| Brief Summary |
This is a Multicenter, observer-blinded, randomized, Active controlled, Phase 3 study in healthy 6 months to 45 years aged Nepalese at the time of the first vaccine dose. The study objectives are: I. Demonstrate non-inferiority of Vi-DT compared to Typbar TCV® as measured by seroconversion rates of anti-Vi IgG ELISA antibody titers, 4 weeks after single dose (pooled immunogenicity of three lots of Vi-DT) II. Demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT of three lots of Vi-DT vaccine 4 weeks after single dose. |
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| Detailed Description |
Subjects will be stratified according to age. The study procedure is as follows: Visit 1 (day-1 to -7): Screen participants by medical/medications history, physical examination, Vital signs, Urine pregnancy test (UPT) Visit 2 (day 0): Enroll, randomize and administer vaccine to eligible participants and assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments. Visit 3 (day 7): Check solicited adverse reaction 7 days post vaccination and Assess participant safety by physical examination and Vital signs Visit 4 (day 28): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments Visit 5 (day 84): Assess participant safety by physical examination and Vital signs Visit 6 (day 168): Assess participant safety by physical examination and Vital signs, Collect blood for immunogenicity assessments, 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. For retention: After vaccination, field health worker/designee will contact participant every day till Day 7 by physical visit or by phone call. Follow-up reminder calls will be done very frequently as per discretion of study staff until 24 weeks for all participant to assess participant safety. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants age 6 months to 45 years Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: This study is observer blind:
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| Condition ICMJE | Typhoid | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
1800 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | January 2021 | ||||
| Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 6 Months to 45 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Nepal | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03933098 | ||||
| Other Study ID Numbers ICMJE | IVI T003 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | International Vaccine Institute | ||||
| Study Sponsor ICMJE | International Vaccine Institute | ||||
| Collaborators ICMJE | SK Bioscience Co., Ltd. | ||||
| Investigators ICMJE |
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| PRS Account | International Vaccine Institute | ||||
| Verification Date | April 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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