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Published on: July 28, 2023
A Phase II/III, Multicenter, Observer-blinded, Randomized, Non-inferiority and Safety, study of typhoid conjugate
Yeong Ok Baik1, Youngjin Lee1, Chankyu Lee2
1EuBiologics Co., Ltd., Seoul, Republic of Korea.
Insights
The typhoid conjugate vaccine (TCV) EuTCV demonstrated high efficacy and safety in a Phase II/III trial. This new TCV offers comparable immunogenicity and safety to existing vaccines, supporting its use in diverse age groups.
Area of Science:
- Vaccinology
- Immunology
- Clinical Trials
Background:
- Typhoid conjugate vaccines (TCVs) offer long-lasting immunity and are suitable for young children.
- Previous Phase I studies indicated EuTCV has good immunogenicity and safety.
- Further evaluation in Phase II/III trials was warranted to confirm efficacy.
Purpose of the Study:
- To evaluate the efficacy and safety of EuTCV in healthy Filipino participants aged 6 months to 45 years.
- To compare the immunogenicity and safety profile of EuTCV against the comparator vaccine Typbar-TCV®.
- To assess batch-to-batch consistency of the EuTCV vaccine.
Main Methods:
- A Phase II/III clinical trial (NCT04830371) involving healthy Filipino participants.
- Administration of EuTCV (Arms A, B, C) or Typbar-TCV® (Arm D).
- Sera sample collection pre- and post-vaccination for immunogenicity assessment; regular monitoring for adverse events.
Main Results:
- EuTCV showed comparable safety with no significant difference in adverse events compared to Typbar-TCV®.
- A single dose of EuTCV achieved 99.4% seroconversion, demonstrating non-inferior immunogenicity to Typbar-TCV®.
- Batch-to-batch consistency for EuTCV was confirmed within equivalence margins.
Conclusions:
- EuTCV exhibits comparable safety and significant immunogenicity to Typbar-TCV® in healthy individuals.
- The results meet the objectives of the pivotal Phase II/III study, supporting EuTCV's potential as an effective typhoid vaccine.
- EuTCV demonstrates batch-to-batch consistency, crucial for vaccine manufacturing and deployment.
Abstract:
The typhoid conjugate vaccine (TCV) ensures a long-lasting protective immune response, requires fewer doses and is fit for children under 2 years of age. From Phase I study, EuTCV displayed considerable immunogenicity and reliable safety, thus endorsing further examination in Phase II/III trials. Therefore, a clinical Phase II/III study (NCT04830371) was conducted to evaluate its efficacy in healthy Filipino participants aged 6 months to 45 years through administration of the test vaccine (Arm A, B, and C) or comparator vaccine Typbar-TCV® (Arm D). Sera samples were collected pre-vaccination (Visit 1) and post-vaccination (Visit 4, Day 28) to assess the immunogenicity of EuTCV and Typbar-TCV®. During the study, participants were regularly monitored through scheduled visits to the clinic to report any adverse events associated with the vaccine. For vaccine safety, the proportion of solicited and unsolicited Treatment-Emergent Adverse Events was all comparable between EuTCV and Typbar-TCV® groups. A single dose of EuTCV produced seroconversion in 99.4% of treated participants, with seroconversion rates non-inferior to that of Typbar-TCV®. Batch-to-batch consistency was concluded based on the 90% Confidence Interval of the geometric mean ratio (EuTCV Arm A, B, and C) at Week 4, lying within the equivalence margin of 0.5 to 2.0 for all batches. Results from this Phase II/III clinical trial of EuTCV in healthy volunteers show comparable safety and considerable immunogenicity, compared to Typbar-TCV®, meeting the objectives of this pivotal study. ClinicalTrials.gov registration number: NCT04830371.
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