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

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Brief Title

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

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.

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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Seroconversion rate1

Secondary Outcome

 Geometric Mean Titers (GMT) 2

Condition

Typhoid

Intervention

Test Vaccine Vi-DT Typhoid conjugate

Study Arms / Comparison Groups

 Test group A: Lot 1 Vi-DT (typhoid conjugate vaccine)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1800

Start Date

November 15, 2019

Completion Date

January 2021

Primary Completion Date

September 2020

Eligibility 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. History of uncontrolled coagulopathy or blood disorders

         12. 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

         13. Any female participant who is lactating, pregnant* or planning for pregnancy during
             the course of study period

         14. Participants/Parents/LAR planning to move from the study area before the end of study
             period

         15. As per Investigator's medical judgement individuals could be excluded from the study
             inspite of meeting all inclusion/exclusion criteria mentioned above

             Temporary Contraindication

         16. 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
      

Gender

All

Ages

6 Months - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ganesh Kumar Rai, MD, , 

Location Countries

Nepal

Location Countries

Nepal

Administrative Informations


NCT ID

NCT03933098

Organization ID

IVI T003


Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 SK Bioscience Co., Ltd.

Study Sponsor

Ganesh Kumar Rai, MD, Principal Investigator, Kanti Children's Hospital


Verification Date

April 2020