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

NCT03956524 | Completed Phase 1

• 1 other identifier: UTCV_101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (3)

• Local and systemic solicited adverse events

  Day 7

• Unsolicited adverse events

  up to 6 weeks

• Serious adverse events

  up to 6 weeks

Secondary Outcomes (1)

• Proportion of subjects with seroconversion

  Baseline to Day 42

Study Arms (3)

Test group

EXPERIMENTAL

Single dose of EuTCV will be administered intramuscularly

Biological: EuTCV

Comparator group 1

ACTIVE COMPARATOR

Single dose of Typbar-TCV™ will be administered intramuscularly

Biological: Typbar-TCV™

Comparator group 2

ACTIVE COMPARATOR

Single dose of Typhim Vi® will be administered intramuscularly

Biological: Typhim Vi®

Interventions

EuTCV BIOLOGICAL

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

Test group

Typbar-TCV™ BIOLOGICAL

Single 0.5 mL dose of TCV of Bharat Biotech

Comparator group 1

Typhim Vi® BIOLOGICAL

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

Comparator group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EuBiologics Co.,Ltd: lead

Study Sites (1)

De La Salle Health Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

Location

Related Publications (1)

• 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.

  PMID: 33849723 DERIVED

MeSH Terms

Conditions

Typhoid Fever

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 20, 2019
• Study Start: March 16, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)