Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

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Brief Title

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

Official Title

A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......

Brief Summary

      This is a multicenter, randomized, observer-blinded, controlled, immune equivalence study of
      a multi-dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single
      dose (SD) formulation without preservative of SK bioscience Vi-DT in participant (6 months -
      45 years) including safety population.

      The study objectives are as follows:

        -  Primary objective. Demonstrate the immune equivalence as measured by anti-Vi IgG
           Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of
           Vi-DT (18-45 year age stratum), at 4 weeks after a single dose.

        -  Secondary objective 1. Demonstrate the immune equivalence as measured by seroconversion
           rates of anti-Vi IgG antibody titres of multi dose formulation against single dose
           formulation of Vi-DT vaccine (18-45 year age stratum) at 4 weeks after a single dose.

        -  Secondary objective 2. Describe safety profile in all age strata combined (age 6 months
           - 45 years old) and in each age stratum, at 4 weeks after a single dose of SD/MD
           formulation/control (Meningococcal Conjugate Vaccine).

      There are total 5 scheduled visits as follows:

        -  Visit 1(D-7 to 0): Screening

        -  Visit 2(D0): Enrollment, vaccination, safety follow-up and blood collection for
           immunogenicity assessment (only for subjects 18 years old and above)

        -  Visit 3(D7): Safety follow-up

        -  Visit 4(D28): Safety follow-up and blood collection for immunogenicity assessment (only
           for subjects 18 years old and above)

        -  V5(D168): Safety follow-up
    

Detailed Description

      The vaccines will be administered to 1,500 healthy participants of 6 months to 45 years of
      age and followed up for 24 weeks after the injection for safety. Adult participants (N=500)
      will be followed up for immunogenicity at 4 weeks and all participants till 24 weeks for
      safety post single dose of either MD & SD formulations. 300 healthy participants will be
      given control vaccine (locally available licensed Meningococcal conjugate vaccine) to check
      the background safety events. The primary objective is to demonstrate the equivalence of
      immunogenicity as measured by anti-Vi IgG GMT titer at 4 weeks after a single dose of MD/SD
      formulation in adults. The secondary objective is to demonstrate the equivalence of
      immunogenicity in terms of seroconversion rates as measured by anti-Vi IgG ELISA antibody
      titers, at 4 weeks after a single dose of MD/SD formulation in adults. A descriptive
      evaluation of safety at 4 and 24 weeks post single dose of (SD/MD/Meningococcal vaccine),
      will be performed. The Vi-DT vaccine from both MD & SD formulations will be administered as a
      single dose of 25 µg/0.5 mL.

      Eligible participants enrolled into the study will be randomized into one of the three study
      groups within each age stratum of 6 months to less than 2 years, 2 to less than 18 years, and
      18 to 45 years. Participants will be observed at the study site for 30 minutes after
      vaccination for safety assessment. Solicited adverse events will be recorded on a diary card
      during 7 days after vaccination. Unsolicited adverse events will be recorded during the 4
      weeks after vaccination. Serious adverse events will be recorded during the entire study
      period. With the exception of designated study site personnel responsible for vaccine
      administration, site investigators, study nurse, and those assessing clinical outcomes, and
      data analysts will be blinded to vaccine allocation until data base lock for the final
      analysis.

      Blood samples will be collected at baseline prior to vaccination and at 4 weeks post
      vaccination from adults (18-45 years) for immunogenicity assessment
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Geometric Mean Titers (GMT) of anti-Vi IgG

Secondary Outcome

 Seroconversion rates of anti-Vi IgG ELISA antibody titres

Condition

Typhoid

Intervention

Vi-DT (Multi-dose formulation)

Study Arms / Comparison Groups

 Vi-DT Multi-dose
Description:  750 participants (6 mo - 45 yrs)
Dose: 0.5mL, Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein (Vi-DT), manufactured by SK bioscience (Republic of Korea)
Dosage form: Liquid, 25µg Vi polysaccharide/0.5mL, presented in Type I glass vial (multi-dose formulation Vi-DT contains preservative 2 PE)
Mode of Administration: Intramuscular injection
Frequency of administration: Once

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

February 4, 2020

Completion Date

February 28, 2021

Primary Completion Date

September 11, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy participants 6 months to 45 years of age at enrollment

          2. Participants/Parent(s)/LAR who have voluntarily given informed consent/assent

          3. Participants/Parent(s)/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. Participant who has already received meningococcal conjugate vaccine

          3. Participants concomitantly enrolled or scheduled to be enrolled in another trial

          4. Known history of immune function disorders including immunodeficiency diseases (Known
             HIV infection or other immune function disorders)

          5. 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

          6. Receipt of blood or blood-derived products in the past 3 months

          7. Participant with a previously ascertained or suspected disease caused by S. Typhi
             (confirmed either clinically, serologically or microbiologically)

          8. Participant who has had household contact with and/or intimate exposure to an
             individual with laboratory-confirmed S. Typhi

          9. Individual who has previously received a typhoid vaccine

         10. Participant who has received other vaccines from 1 month prior to test vaccination or
             planned to receive any vaccine within 1 month (except a measles containing vaccine as
             per government vaccination campaign)

         11. Known history or allergy to vaccines or other medications

         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 participant 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/Parent(s)/LAR planning to move from the study area before the end of
             study period

         16. As per Investigator's medical judgement individual could be excluded from the study in
             spite of meeting all inclusion/exclusion criteria mentioned above
      

Gender

All

Ages

6 Months - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Josefina C Carlos, MD, +82-10-9804 1348, [email protected]

Location Countries

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT04204096

Organization ID

IVI T004


Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 SK Bioscience Co., Ltd.

Study Sponsor

Josefina C Carlos, MD, Principal Investigator, University of the East-Ramon Magsaysay Memorial Medical Center Inc.


Verification Date

August 2020