Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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Brief Title

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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

Brief 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. To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid

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

      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

      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

Study Phase

Phase 1

Study Type


Primary Outcome

Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events

Secondary Outcome

 Proportion of participants with sero-conversion





Study Arms / Comparison Groups

 Test group
Description:  Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28).


* 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


Estimated Enrollment


Start Date

May 19, 2016

Completion Date

February 9, 2017

Primary Completion Date

February 9, 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy male and female individual 2-45 years of age

          2. Participants/Parents who have voluntarily given informed consent and/or assent.

          3. Participants/Parents willing to commit complying with the study procedures of the
             investigator and available for the entire duration of study

        Exclusion Criteria:

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

          2. Acute illness, in particular infectious diseases or fever (axillary temperature >
             38°C), with in three days prior to enrollment and vaccination.

          3. Known history of allergy to vaccines or other medications

          4. Known history of allergy to egg, chiken protein, neomycin and formaldehyde.

          5. History of uncontrolled coagulopathy or blood disorders

          6. 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

          7. 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

          8. Pregnancy & Lactation (female adults)

          9. Female with child-bearing potential during the study period. i.e., sexually active and
             not practicing effective acceptable contraceptive method

         10. Individuals who have previously received any vaccines against typhoid fever

         11. 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

         12. Individuals who have a previously ascertained or suspected disease caused by S. typhi.

         13. Individuals who have had household contact with/and or intimate exposure to an
             individual with laboratory-confirmed S. typhi

         14. History of alcohol or substance abuse

         15. Subject planning to move from the study area before the end of study period




2 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Maria Rosario Capeding, MD, , 

Administrative Informations



Organization ID

IVI T001

Responsible Party


Study Sponsor

International Vaccine Institute


 SK Chemicals Co., Ltd.

Study Sponsor

Maria Rosario Capeding, MD, Principal Investigator, Research Institution for Tropical Medicine

Verification Date

February 2018