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Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933098
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
SK Bioscience Co., Ltd.
Information provided by (Responsible Party):
International Vaccine Institute

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.


Condition or disease Intervention/treatment Phase
Typhoid Biological: Test Vaccine Vi-DT Typhoid conjugate Biological: Control Vaccine Typbar TCV® Phase 3

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 : 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:

  1. Vaccine administrator and vaccine safety evaluator at site will be two distinct persons.
  2. Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
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.
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


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).

MMR for age group at 9-15 months.

Biological: Test Vaccine Vi-DT Typhoid conjugate
  • Manufacturer: SK Bioscience Co., Ltd.
  • Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid
  • Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Other Name: Vi-DT Typhoid conjugate vaccine

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).

MMR for age group at 9-15 months.

Biological: Test Vaccine Vi-DT Typhoid conjugate
  • Manufacturer: SK Bioscience Co., Ltd.
  • Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid
  • Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Other Name: Vi-DT Typhoid conjugate vaccine

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).

MMR for age group at 9-15 months.

Biological: Test Vaccine Vi-DT Typhoid conjugate
  • Manufacturer: SK Bioscience Co., Ltd.
  • Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid
  • Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial
Other Name: Vi-DT Typhoid conjugate vaccine

Active Comparator: Test group D: Typbar TCV

One dose of Typbar TCV will be administrated intramuscularly at Enrollment visit (Day 0).

MMR for age group at 9-15 months.

Biological: Control Vaccine Typbar TCV®
  • Manufacturer: Bharat Biotech
  • Ingredient: Purified Vi capsular polysaccharide of Salmonella Ty2 conjugated to tetanus toxoid protein
  • Dose: 0.5 ml
Other Name: Typbar TCV®




Primary Outcome Measures :
  1. 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

  2. Geometric Mean Titers (GMT)1 [ Time Frame: 4 weeks after vaccination of Vi-DT(pooled)/ Typbar TCV® ]
    Measurement of the Geometric Mean Titers (GMT) following 4 weeks after vaccination of three lots of Vi-DT(pooled)


Secondary Outcome Measures :
  1. 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®

  2. 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

  3. 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.

  4. 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

  5. Seroconversion rate 5 [ Time Frame: 4 weeks (28 days) after vaccination of MMR compared to baseline (D0) ]
    Definded as IgG ELISA antibody titers for Measles (M), Mumps (M) and Rubella (R) following single dose of MMR a vaccine at baseline D0 and 4 weeks

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy participants 6 months to 45 years of age at enrollment
  2. Participants/Parents/LAR who have voluntarily given informed consent/assent
  3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study

Exclusion Criteria:

  1. Child with a congenital abnormality
  2. Subject concomitantly enrolled or scheduled to be enrolled in another trial
  3. Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
  4. 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
  5. Receipt of blood or blood-derived products in the past 3 months
  6. Subject with a previously ascertained or suspected disease caused by S. Typhi
  7. Subject who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. Typhi
  8. Individual who has previously received a typhoid vaccine
  9. 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
  10. Known history or allergy to vaccines or other medications
  11. Known history of allergy to eggs, chicken protein, neomycin and formaldehyde
  12. History of uncontrolled coagulopathy or blood disorders
  13. 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
  14. Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period
  15. Participants/Parents/LAR planning to move from the study area before the end of study period
  16. As per Investigator's medical judgement individuals could be excluded from the study inspite of meeting all inclusion/exclusion criteria mentioned above

    Temporary Contraindication

  17. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933098


Contacts
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Contact: Bomi Kim, Bachelor 82-2-881-1279 ext 279 BoMi.Kim@ivi.int
Contact: Tarun Saluja, MD 82-2-881-1236 ext 236 Tarun.Saluja@ivi.int

Locations
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Nepal
Nepalgunj medical college Not yet recruiting
Banke, City- Nepalgunj, Nepal
Contact: Piush Kanodia, MD    00977-9858024990    piushkanodia@yahoomail.com   
B.P.Koirala Institute of Health Sciences Not yet recruiting
Rautahat, Dharan, Nepal
Contact: Shipra Chaudhary, MD    977 984 2054313    nowshipra@gmail.com   
Dhulikhel Hospital Not yet recruiting
Kavre, Dhulikhel, Nepal
Contact: Dipesh Tamrakar    977-980-1002404    bob.dipesh@gmail.com   
Kanti Children's Hospital Not yet recruiting
Kathmandu, Sukedhara, Nepal, 44600
Contact: Ganesh Kumar Ra, MD    977-9851044163    drganeshrai@gmail.com   
Contact: Bishnu Rath Giri, MD    977-9851133466    giribishnurath@gmail.com   
Sponsors and Collaborators
International Vaccine Institute
SK Bioscience Co., Ltd.
Investigators
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Principal Investigator: Ganesh Kumar Rai, MD Kanti Children's Hospital

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Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT03933098     History of Changes
Other Study ID Numbers: IVI T003
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Vaccine Institute:
Typhoid conjugate vaccine
Vi-DT
Safety
Immunogenicity
Additional relevant MeSH terms:
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Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs