Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine
|ClinicalTrials.gov Identifier: NCT02645032|
Recruitment Status : Completed
First Posted : January 1, 2016
Last Update Posted : February 14, 2018
This is a Phase I, Randomized, observer-blinded, age de-escalating study.
The study objectives are:
- To evaluate the safety of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- To assess the immunogenicity of 25 μg of Vi-DT typhoid conjugate vaccine administered at 0 and 4 weeks.
- 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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.|
|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|
Experimental: Test group
Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28).
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
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
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.
- 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)
- 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
- 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
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
|Principal Investigator:||Maria Rosario Capeding, MD||Research Institution for Tropical Medicine|