NCT02645032

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 2 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Typhoid

Interventions

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

Timeline

• Start date: 2016-05-19
• Primary completion: 2017-02-09
• Completion: 2017-02-09
• First posted: 2016-01-01
• Last updated: 2020-04-28