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Safety, Reactogenicity and Immunogenicity of 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03527355
Recruitment Status : Active, not recruiting
First Posted : May 17, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
SK Chemicals Co., Ltd.
Information provided by (Responsible Party):
International Vaccine Institute

Brief Summary:

This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23 months of age at the time of the first vaccine dose.

The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in age group 6-23months of age.

The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6 months apart.


Condition or disease Intervention/treatment Phase
Typhoid Biological: Vi-DT Biological: FluQuadri™ Other: 0.9% sodium chloride isotonic solution Phase 2

Detailed Description:
This study is carried out in healthy children aged 6 to 23 months at a single site. A total of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR) vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR only and to MMR and Vi-DT vaccines are performed to assess the possible immunological interference with MMR vaccine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants age 6-23 months
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer Blinded
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month Old Healthy Filipino Infants and Toddlers
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : July 28, 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A (Single dose)

One dose of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly at first dost (Day 0).

One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Week 24).

One booster dose of Vi-DT 0.5 mL is administrated 2 years apart (Week 96). MMR for age group at 9-12 months.

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

Biological: FluQuadri™

Manufacturer: Sanofi Pasteur Dose: 0.25 ml

*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.


Active Comparator: B (Two dose)

Two doses of Vi-DT (Typhoid conjugate vaccine) 25 µg 0.5 mL is administrated intramuscularly 6 months apart (Day 0 and Day 168 (Week 24)).

MMR for age group at 9-12 months.

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

Placebo Comparator: C (Placebo/Comparator)

One dose of Placebo (0.9% sodium chloride isotonic solution) 0.5 mL is administrated intramuscularly at first dost (Day 0).

One dose of FluQuadri™ 0.25mL is administrated intramuscularly at second dose (Day 168; Week 24).

MMR for age group at 9-12 months.

Biological: FluQuadri™

Manufacturer: Sanofi Pasteur Dose: 0.25 ml

*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.


Other: 0.9% sodium chloride isotonic solution
Manufacture: Euro-Med Inc. Dose: 0.5 mL




Primary Outcome Measures :
  1. Safety endpoints: solicited and unsolicited adverse events and serious adverse events [ Time Frame: Solicited AE: during 7 days after each vaccination. Unsolicited AE: after the first vaccination until 4 weeks after the second vaccination. SAE will be captured after the first vaccination up to week 100 for Group A, week 96 for Group B, week 36 Group C ]
    • Frequency (percentage) of solicited local reactions at the injection site: Pain, tenderness, erythema/redness, swelling/induration and pruritus local
    • Frequency (percentage) of solicited systemic reactions: Fever, lethargy, irritability, vomiting, diarrhea, drowsiness, loss of appetite, persistent crying, rash and nasopharyngitis
    • Frequency (percentage) of unsolicited adverse events
    • Frequency (percentage) of serious adverse events


Secondary Outcome Measures :
  1. Immunogenicity Endpoints [ Time Frame: At week 28, 4 weeks after the second vaccination ]
    Seroconversion rate of anti-Vi IgG by Geometric Mean Titers (GMT) will be measured 4 weeks after the second vaccination using an in-house ELISA assay using standardized reagents and reference serum. The level of the specific anti-Vi IgG in ELISA units for each serum sample is determined by comparison to a reference serum. The number of anti-Vi IgG positive sera will be used to calculate the seroconversion rates.


Other Outcome Measures:
  1. Exploratory Endpoints [ Time Frame: At week 4, 4 week after MMR vaccination ]
    Seroconversion rates of Measles, Mumps and Rubella will be determined 4 week after MMR vaccination. Serum titers will be measured by routinely used commercially available ELISA kits. Kit-specific threshold of positivity will be used to determine specific seroconversion rates.

  2. Exploratory Endpoints [ Time Frame: At week 28, 4 weeks after the second vaccination and at week 96 after the booster dose in selected group. ]
    Serum bactericidal titers will be determined using in-house functional assay assessing the number of survived S. Typhi Ty2 strain colony on Luria-Bertani plate. Serum bactericidal titer is defined as the highest dilution of serum that gives 50% of inhibition of colony formation of S. Typhi.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical jugment of the investigator
  • Birth weight ≥ 2500 g
  • ≥ 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant
  • Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent
  • Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study

Exclusion Criteria:

  • Child with a congenital abnormality
  • Subject with abnormal routine biological values at screening
  • Subject concomitantly enrolled or scheduled to be enrolled in another trial
  • Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination
  • 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
  • Child with a previously ascertained or suspected disease caused by S. typhi
  • Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
  • Known history or allergy to vaccines or other medications
  • Know history of allergy to eggs, chicken protein, neomycin and formaldehyde
  • History of uncontrolled coagulopathy or blood disorders
  • Mother has known HIV infection or other immune function disorders
  • 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
  • Child whose parents or legal guardian 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): NCT03527355


Locations
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Philippines
Research Institute for Tropical Medicine(RITM)
Alabang, Muntinlupa City, Philippines, 1781
Sponsors and Collaborators
International Vaccine Institute
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Maria Rosario Capeding, MD Research Institute for Tropical Medicine(RITM) FCC, Alabang, Muntinlupa city, Philippines, 1781

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Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT03527355     History of Changes
Other Study ID Numbers: IVI T002
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
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
Vi-DT
Conjugate vaccine
First in human
New vaccine

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