Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, Active-Controlled Phase 3 Trial.

Abstract

BACKGROUND:

Although the combination tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) is recommended at adolescence in developed countries, the tetanus and diphtheria toxoid vaccine (Td), which is less costly, is recommended instead in some parts of the world. A new Td, BR-TD-1001, was developed by a Korean manufacturer for distribution to endemic regions and for use in the initial step of novel Tdap development.

METHODS:

This phase 3, randomized, double-blind, multi-center trial, conducted in Korea, aimed to evaluate the immunogenicity and safety of BR-TD-1001. Healthy children aged 10 to 12 years were randomized 1:1 to receive either BR-TD-1001 or the control Td (Td-pur, GlaxoSmithKline). Antibodies were measured using enzyme-linked immunosorbent assay.

RESULTS:

A total of 218 subjects (BR-TD-1001, n = 108; control, n = 110) were enrolled and included in the safety analysis. Vaccine-mediated antibody responses were similar in both groups. We confirmed the non-inferiority of BR-TD-1001 against the control, Td; 100% of both groups achieved seroprotection against diphtheria and tetanus. Furthermore, there was no significant difference between groups in the proportion of participants who demonstrated boost responses against diphtheria and tetanus toxoids. The incidence of solicited local and systemic adverse events (AEs), unsolicited AEs, and serious AEs did not differ significantly between groups.

CONCLUSION:

The BR-TD-1001 satisfied the immunological non-inferiority criterion against diphtheria and tetanus, with a clinically acceptable safety profile.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04618939.

• Authors: Ui Yoon Choi, Ki Hwan Kim, Jin Lee, Byung Wook Eun, Hwang Min Kim, Kyung-Yil Lee, Dong Ho Kim, Sang Hyuk Ma, Jina Lee, Jong-Hyun Kim
• Journal: Journal of Korean medical science (J Korean Med Sci) Vol. 36 Issue 49 Pg. e313 (Dec 20 2021) ISSN: 1598-6357 [Electronic] Korea (South)
• PMID: 34931494 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2021 The Korean Academy of Medical Sciences.

Chemical References

• Antibodies, Bacterial
• Diphtheria-Tetanus Vaccine

Topics

• Antibodies, Bacterial (blood)
• Antibody Formation
• Child
• Diphtheria (immunology, prevention & control)
• Diphtheria-Tetanus Vaccine (administration & dosage, adverse effects, immunology)
• Double-Blind Method
• Enzyme-Linked Immunosorbent Assay
• Erythema (etiology)
• Female
• Humans
• Male
• Pain (etiology, pathology)
• Republic of Korea
• Tetanus (immunology, prevention & control)