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Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Primary Purpose

Typhoid Fever

Status

Completed

Phase

Phase 1

Locations

Philippines

Study Type

Interventional

Intervention

EuTCV

Typbar-TCV™

Typhim Vi®

About this trial

This is an interventional treatment trial for Typhoid Fever

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects aged between and including 18 and 45 years at time of Visit 1
Subjects willing to give written informed consent to participate in the trial
Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

Exclusion Criteria:

Subjects unwilling to give his/her consent to participate in the trial
Subjects who have received Typhoid containing vaccines
Subjects who have past history of Typhoid
Subjects already immunized with any licensed vaccine within 4 weeks
Subjects with known hypersensitivity to any component of the study vaccine
Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
Subjects with any abnormality or chronic disease
Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
Subjects who have known history of immune function disorders
Subjects who have known history of administration of blood or blood-derived products
Subjects who have history of alcohol or substance abuse

Sites / Locations

De La Salle Health Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Test group

Comparator group 1

Comparator group 2

Arm Description

Single dose of EuTCV will be administered intramuscularly

Single dose of Typbar-TCV™ will be administered intramuscularly

Single dose of Typhim Vi® will be administered intramuscularly

Outcomes

Primary Outcome Measures

Local and systemic solicited adverse events

Unsolicited adverse events

Serious adverse events

Secondary Outcome Measures

Proportion of subjects with seroconversion

Defined as a 4-fold or more rise in anti-Vi antibody titers

Full Information

NCT ID

NCT03956524

First Posted

May 15, 2019

Last Updated

December 6, 2019

Sponsor

EuBiologics Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03956524

Brief Title

Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Official Title

An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

March 16, 2019 (Actual)

Primary Completion Date

August 31, 2019 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EuBiologics Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.

6. Conditions and Keywords

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

Typhoid Fever

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

Single dose of EuTCV will be administered intramuscularly

Arm Title

Comparator group 1

Arm Type

Active Comparator

Arm Description

Single dose of Typbar-TCV™ will be administered intramuscularly

Arm Title

Comparator group 2

Arm Type

Active Comparator

Arm Description

Single dose of Typhim Vi® will be administered intramuscularly

Intervention Type

Biological

Intervention Name(s)

EuTCV

Intervention Description

Single 0.5 mL dose of TCV of EuBiologics co., Ltd.

Intervention Type

Biological

Intervention Name(s)

Typbar-TCV™

Intervention Description

Single 0.5 mL dose of TCV of Bharat Biotech

Intervention Type

Biological

Intervention Name(s)

Typhim Vi®

Intervention Description

Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

Primary Outcome Measure Information:

Title

Local and systemic solicited adverse events

Time Frame

Day 7

Title

Unsolicited adverse events

Time Frame

up to 6 weeks

Title

Serious adverse events

Time Frame

up to 6 weeks

Secondary Outcome Measure Information:

Title

Proportion of subjects with seroconversion

Description

Defined as a 4-fold or more rise in anti-Vi antibody titers

Time Frame

Baseline to Day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged between and including 18 and 45 years at time of Visit 1 Subjects willing to give written informed consent to participate in the trial Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests Exclusion Criteria: Subjects unwilling to give his/her consent to participate in the trial Subjects who have received Typhoid containing vaccines Subjects who have past history of Typhoid Subjects already immunized with any licensed vaccine within 4 weeks Subjects with known hypersensitivity to any component of the study vaccine Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception Subjects with any abnormality or chronic disease Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid Subjects who have known history of immune function disorders Subjects who have known history of administration of blood or blood-derived products Subjects who have history of alcohol or substance abuse

Facility Information:

Facility Name

De La Salle Health Sciences Institute

City

Dasmariñas

State/Province

Cavite

ZIP/Postal Code

4114

Country

Philippines

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33849723

Citation

Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10.

Results Reference

derived

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Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults

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