Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

NCT02645032 | Completed Phase 1 DMC

• 1 other identifier: IVI T001
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I, Randomized, observer-blinded, age de-escalating study. The study objectives are:

1. 1.To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
2. 2.To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
3. 3.To compare the safety and immunogenicity of Vi-DT and Vi-Polysaccharide typhoid vaccines.

Conditions

Typhoid

Keywords

Typhoid conjugate vaccine; Vi-DT; Safety; Immunogenicuty

Outcome Measures

Primary Outcomes (1)

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

  Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)

  4 weeks post first and second vaccination

Secondary Outcomes (2)

• Proportion of participants with sero-conversion

  4 weeks post first and second injections of Vi-DT and one injection of Vipolysaccharide

• Geometric Mean Titers (GMT)

  4 weeks post first and second vaccination

Study Arms (2)

Test group

EXPERIMENTAL

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

Biological: Vi-DT

Comparator group

ACTIVE COMPARATOR

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®; Biological: VAXIGRIP®

Interventions

Vi-DT BIOLOGICAL

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

Also known as: Vi-DT typhoid conjugate vaccine

Test group

Typhim Vi® BIOLOGICAL

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

Comparator group

VAXIGRIP® BIOLOGICAL

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.

Comparator group

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy male and female individual 2-45 years of age
• Participants/Parents who have voluntarily given informed consent and/or assent.
• Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of study

You may not qualify if:

• Participants concomitantly enrolled or scheduled to be enrolled in another trial
• Acute illness, in particular infectious diseases or fever (axillary temperature \> 38°C), with in three days prior to enrollment and vaccination.
• Known history of allergy to vaccines or other medications
• Known history of allergy to egg, chiken protein, neomycin and formaldehyde.
• History of uncontrolled coagulopathy or blood disorders
• 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
• 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
• Pregnancy \& Lactation (female adults)
• Female with child-bearing potential during the study period. i.e., sexually active and not practicing effective acceptable contraceptive method
• Individuals who have previously received any vaccines against typhoid fever
• 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
• Individuals who have a previously ascertained or suspected disease caused by S. typhi.
• Individuals who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi
• History of alcohol or substance abuse
• Subject planning to move from the study area before the end of study period

Sponsors & Collaborators

• International Vaccine Institute: lead
• SK Chemicals Co., Ltd.: collaborator

Related Publications (1)

• Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo SK, Chon Y, Kothari S, Yang SY, Ham DS, Ryu JH, Hwang HS, Mun JH, Lynch JA, Kim JH, Kim H, Excler JL, Sahastrabuddhe S. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children. Vaccine. 2018 Jun 18;36(26):3794-3801. doi: 10.1016/j.vaccine.2018.05.038.

  PMID: 29776750 DERIVED

Related Links

• Final Result

MeSH Terms

Conditions

Typhoid Fever

Interventions

Vi polysaccharide vaccine, typhoid; vaxigrip

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 Institution for Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 1, 2016
• Study Start: May 19, 2016
• Primary Completion: February 9, 2017
• Study Completion: February 9, 2017
• Last Updated: April 28, 2020

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share