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Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

Primary Purpose

Typhoid

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Vi-DT

Typhim Vi®

VAXIGRIP®

About this trial

This is an interventional prevention trial for Typhoid focused on measuring Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicuty

Eligibility Criteria

2 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Comparator group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Proportion of participants with sero-conversion

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)

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

Full Information

NCT ID

NCT02645032

First Posted

December 22, 2015

Last Updated

April 26, 2020

Sponsor

International Vaccine Institute

Collaborators

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02645032

Brief Title

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

May 19, 2016 (Actual)

Primary Completion Date

February 9, 2017 (Actual)

Study Completion Date

February 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Vaccine Institute

Collaborators

SK Chemicals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Typhoid

Keywords

Typhoid conjugate vaccine, Vi-DT, Safety, Immunogenicuty

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Laboratory personnel who analyzes immunogenicity at sponsor is also blinded.

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator group

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

Vi-DT

Other Intervention Name(s)

Vi-DT typhoid conjugate vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Typhim Vi®

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

VAXIGRIP®

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 weeks post first and second vaccination

Secondary Outcome Measure Information:

Title

Proportion of participants with sero-conversion

Description

Defined as a four-fold rise in anti-Vi antibody titers compared to baseline measured by anti-Vi IgG ELISA and Serum Bactericidal Assay

Time Frame

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

Title

Geometric Mean Titers (GMT)

Description

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

Time Frame

4 weeks post first and second vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Rosario Capeding, MD

Organizational Affiliation

Research Institution for Tropical Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29776750

Citation

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.

Results Reference

derived

Links:

URL

https://doi.org/10.1016/j.vaccine.2018.05.038

Description

Final Result

Learn more about this trial

Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine

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