Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine

NCT03527355 | Completed Phase 2 DMC

• 1 other identifier: IVI T002
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid

Keywords

Typhoid; Vi-DT; Conjugate vaccine; First in human; New vaccine

Outcome Measures

Primary Outcomes (1)

• Safety endpoints: solicited and unsolicited adverse events and serious adverse events

  * 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

  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

Secondary Outcomes (1)

• Immunogenicity Endpoints

  At week 28, 4 weeks after the second vaccination

Other Outcomes (2)

• Exploratory Endpoints

  At week 4, 4 week after MMR vaccination

• Exploratory Endpoints

  At week 28, 4 weeks after the second vaccination and at week 96 after the booster dose in selected group.

Study Arms (3)

A (Single dose)

EXPERIMENTAL

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; Biological: FluQuadri™

B (Two dose)

ACTIVE COMPARATOR

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

C (Placebo/Comparator)

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™; Other: 0.9% sodium chloride isotonic solution

Interventions

Vi-DT BIOLOGICAL

Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial

Also known as: Vi-DT typhoid conjugate vaccine

A (Single dose); B (Two dose)

FluQuadri™ BIOLOGICAL

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.

A (Single dose); C (Placebo/Comparator)

0.9% sodium chloride isotonic solution OTHER

Manufacture: Euro-Med Inc. Dose: 0.5 mL

C (Placebo/Comparator)

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical judgment 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• SK Bioscience Co., Ltd.: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Research Institute for Tropical Medicine(RITM)

Alabang, Muntinlupa City, 1781, Philippines

Location

Related Publications (2)

• Capeding MR, Sil A, Tadesse BT, Saluja T, Teshome S, Alberto E, Kim DR, Park EL, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ryu JH, Cheong I, Shim KY, Lee Y, Kim H, Lynch JA, Kim JH, Excler JL, Wartel TA, Sahastrabuddhe S. Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: Phase II, randomized, dose-scheduling, observer-blind Study. EClinicalMedicine. 2020 Sep 9;27:100540. doi: 10.1016/j.eclinm.2020.100540. eCollection 2020 Oct.

  PMID: 33150320 DERIVED

• Capeding MR, Alberto E, Sil A, Saluja T, Teshome S, Kim DR, Park JY, Yang JS, Chinaworapong S, Park J, Jo SK, Chon Y, Yang SY, Ham DS, Ryu JH, Lynch J, Kim JH, Kim H, Excler JL, Wartel TA, Sahastrabuddhe S. Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report. Vaccine. 2020 Jun 9;38(28):4476-4483. doi: 10.1016/j.vaccine.2019.09.074. Epub 2019 Oct 1.

  PMID: 31585725 DERIVED

Related Links

• A preliminary report

MeSH Terms

Conditions

Typhoid Fever

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Maria Rosario Capeding, MD

  Research Institute for Tropical Medicine, Metro Manila, Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants age 6-23 months

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: May 17, 2018
• Study Start: April 18, 2018
• Primary Completion: July 28, 2018
• Study Completion: January 19, 2021
• Last Updated: August 27, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)