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

NCT03956524 — Phase 1, Completed, 75 participants, EuBiologics Co.,Ltd

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

Registry	NCT03956524
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	75 (Actual)
Sponsor	EuBiologics Co.,Ltd (Industry)
Conditions	Typhoid Fever
Interventions	EuTCV, Typbar-TCV™, Typhim Vi® (Biological)
Dates	start 2019-03-16, primary completion 2019-08-31, completion 2019-08-31, first posted 2019-05-20, last updated 2019-12-09
Locations	1 site in Philippines

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Test group	Experimental	Biological: EuTCV	Single dose of EuTCV will be administered intramuscularly
Comparator group 1	Active comparator	Biological: Typbar-TCV™	Single dose of Typbar-TCV™ will be administered intramuscularly
Comparator group 2	Active comparator	Biological: Typhim Vi®	Single dose of Typhim Vi® will be administered intramuscularly

EuTCV (Biological): Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
Typbar-TCV™ (Biological): Single 0.5 mL dose of TCV of Bharat Biotech
Typhim Vi® (Biological): Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur

+Outcome measures

Primary outcomes

Local and systemic solicited adverse events [Day 7]
Unsolicited adverse events [up to 6 weeks]
Serious adverse events [up to 6 weeks]

Secondary outcomes

Proportion of subjects with seroconversion [Baseline to Day 42]: Defined as a 4-fold or more rise in anti-Vi antibody titers

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
De La Salle Health Sciences Institute	Dasmariñas, Cavite	Philippines

+Publications

Results publication: 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