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Trial record 11 of 45 for:    "Typhoid fever"

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT02645032
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
SK Chemicals Co.,Ltd.
Information provided by (Responsible Party):
International Vaccine Institute

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 vaccines.

Condition or disease Intervention/treatment Phase
Typhoid Biological: Vi-DT Biological: Typhim Vi® Biological: VAXIGRIP® Phase 1

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 participants

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 examination

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 administrator.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
Primary Purpose: Prevention
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
Actual Study Start Date : May 19, 2016
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test group
Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28).
Biological: Vi-DT
Manufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
Other Name: Vi-DT typhoid conjugate vaccine

Active Comparator: Comparator group

Biological/Vaccine:

One dose of Typhim Vi® will be administrated intramuscularly at 1st dose (Day 0).

One dose of VAXIGRIP® will be administrated intramuscularly at 2nd dose (Day 28).

Biological: Typhim Vi®
Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial

Biological: VAXIGRIP®

Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose)

*Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort.





Primary Outcome Measures :
  1. Safety endpoints for solicited adverse events (reactogenicity) and serious adverse events [ Time Frame: 4 weeks post first and second vaccination ]
    Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)


Secondary Outcome Measures :
  1. Proportion of participants with sero-conversion [ Time Frame: 4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide ]
    Defined as a four-fold rise in anti-Vi antibody titers compared to baseline measured by anti-Vi IgG ELISA and Serum Bactericidal Assay

  2. Geometric Mean Titers (GMT) [ Time Frame: 4 weeks post first and second vaccination ]
    Measurement of the Geometric Mean Titers (GMT) following 4 weeks post first and second injections of Vi-DT and one injection of Vi-polysaccharide vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02645032


Sponsors and Collaborators
International Vaccine Institute
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Maria Rosario Capeding, MD Research Institution for Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT02645032     History of Changes
Other Study ID Numbers: IVI T001
First Posted: January 1, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Immunogenicuty

Additional relevant MeSH terms:
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs