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

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

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.

Study Overview

• Status: Completed
• Conditions: Typhoid Fever
• Intervention / Treatment: Biological: EuTCV; Biological: Typbar-TCV™; Biological: Typhim Vi®

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Philippines
  • Cavite
    • Dasmariñas, Cavite, Philippines, 4114
      • De La Salle Health Sciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; Single dose of EuTCV will be administered intramuscularly	Biological: EuTCV; Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
Active Comparator: Comparator group 1; Single dose of Typbar-TCV™ will be administered intramuscularly	Biological: Typbar-TCV™; Single 0.5 mL dose of TCV of Bharat Biotech
Active Comparator: Comparator group 2; Single dose of Typhim Vi® will be administered intramuscularly	Biological: Typhim Vi®; Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local and systemic solicited adverse events	Day 7
Unsolicited adverse events	up to 6 weeks
Serious adverse events	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with seroconversion	Defined as a 4-fold or more rise in anti-Vi antibody titers	Baseline to Day 42

Collaborators and Investigators

• Sponsor: EuBiologics Co.,Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever
• Other Study ID Numbers: UTCV_101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No