A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults

Jacob, Louis; Choi, Jung‐Hyun; Wie, Seong Heon; Choi, Su-Mi; Lee, Mi Suk; Kim, Tae Hyong; Kang, Jin Han

doi:10.3346/jkms.2019.34.e31

Cited by 5 publications

(6 citation statements)

References 14 publications

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“…However, if adults younger than 30 years were regularly booster-immunised at an interval of 10-16 years, then 100% of them were seroprotected. Similar results were documented in other studies focused on booster immunisation of adults [9][10][11].…”

Section: Discussionsupporting

confidence: 91%

Factors Influencing Persistence of Diphtheria Immunity and Immune Response to a Booster Dose in Healthy Slovak Adults

et al. 2019

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We assessed the long-term persistence of humoral immunity against diphtheria in adults with childhood vaccination and the immunogenicity of a booster dose considering demographic, behavioural and vaccinating factors. We conducted a trial in 200 healthy Slovak adults aged 24–65 years, immunised against diphtheria in childhood and against tetanus at regular 10–15 year intervals, and receiving a dose of a tetanus-diphtheria toxoid vaccine. The response was determined by ELISA antibody concentrations of paired sera before and at 4 weeks post-vaccination. A seroprotection rate of 21% (95% confidence interval, CI 15.6–27.3%) was found in adults up to 59 years since the last vaccination with seroprotective levels of antibodies against diphtheria ≥0.1 IU/mL and a geometric mean concentration of 0.05 IU/mL. Conversely, seropositive levels ≥0.01 IU/mL were observed in 98% of adults (95% CI 95–99.5%). Booster-induced seroprotection was achieved in 78% of adults (95% CI 71.6–83.5%) clearly depending on pre-booster antibody levels correlating with age and time since the last vaccination. Moreover, only 54.2% of smokers and 53.3% of patients on statins exhibited seroprotection. Booster vaccination against diphtheria was unable to confer seroprotection in all recipients of only childhood vaccination.

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Section: Discussionsupporting

confidence: 91%

Factors Influencing Persistence of Diphtheria Immunity and Immune Response to a Booster Dose in Healthy Slovak Adults

et al. 2019

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“…Chaparro et al [ 43 ]* Hepatitis B vaccine • Fendrix vaccine group: 17% • Engerix vaccine group: 4.3% • No placebo group reported • No grading system reported Data reported only specified 18 participants presented mild VAEs related to the vaccine 42. Lee et al [ 44 ]* Adult tetanus diphtheria vaccine • GC1107 vaccine: 22/250 (8.80%) • Control group: 21/125 (16.80%) • No grading system reported • Incidence of all reported VAEs in the GC1107 vaccine group: 84.8% • Incidence of reported VAEs in the control group: 88.0% • Headache was grouped with pain, pressure, irritation, swelling, fever, vomiting, nausea diarrhea, fatigue and myalgia and reported as solicited VAEs Headache in the control group was greater than headache in the GC1107 vaccine group 43. Arredondo et al [ 45 ]* Concomitant dengue and HPV vaccine • Concomitant vaccine group: 185/231 (80.1%) • Sequential Concomitant vaccine group: 196/234 (83.8%) • Sequential vaccine group: 129/151 (85.4% • No placebo group reported • No grading system reported Headache was combined with fever, malaise, myalgia, and asthenia to make up solicited systemic reactions category • There was no difference in safety outcomes across vaccine groups 44.…”

Section: Methodsmentioning

confidence: 99%

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Garces

Cocores

Goadsby

et al. 2022

Curr Pain Headache Rep

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Purpose of Review The aim of this review is to characterize headache as a vaccine adverse event (VAE) in clinical trials. Recent Findings Of the recent phase III vaccine RCTs (non-COVID-19), 53 studies reported on headache (13 infectious agents). The median rate (interquartile range) of headache was 15.6% ( IQR : 9.6–37.6%). Of these, 24.5% of the RCTs reported headache greater in the vaccine group compared to the placebo/control group. In the herpes zoster vaccination trials, headache was more common in all active groups: median rate 33.9% ( IQR : 29.7–40.5%) as compared to placebo: median rate 17.7% ( IQR : 15.4–23.8%). Influenza and HPV vaccination trials were the 2nd and 3rd most common to have headache as a VAE. Of the 6 widely distributed COVID-19 vaccinations, median rate of post-vaccination headache was 39% ( IQR : 28–50%). Summary Headache is a common VAE in vaccine trials. Standardized grading methods, predictors of persistence, and treatment regimens are warranted.

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“…Despite a large number of studies on the immunogenicity and safety of Tdap and efforts to develop a new Tdap, 12 13 14 the development of Td has been limited. A new Td, BR-TD-1001, has been developed by a Korean pharmaceutical manufacturer with two purposes: for its supply to countries where Td is used widely and for its use in the initial step of novel Tdap development with the plan of adding acellular pertussis antigens.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2021

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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

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A Phase III Study to Evaluate the Immunogenicity and Safety of GC1107 (Adult Tetanus Diphtheria Vaccine) in Healthy Adults

Cited by 5 publications

References 14 publications

Factors Influencing Persistence of Diphtheria Immunity and Immune Response to a Booster Dose in Healthy Slovak Adults

Factors Influencing Persistence of Diphtheria Immunity and Immune Response to a Booster Dose in Healthy Slovak Adults

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

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

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