Development and implementation of standardized method for detecting immunogenicity of acellular pertussis vaccines in Korea

Park, Chulmin; Huh, Dong Ho; Han, Seung Beom; Choi, Gi Sub; Kang, Kyu Ri; Kim, Ji Ahn; Kang, Jin Han

doi:10.7774/cevr.2019.8.1.35

Cited by 6 publications

(8 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Thus, evaluation of humoral response after pertussis vaccination is immensely significant. In this study, compared to the positive control, the GC3111 group showed lower anti-FHA antibody level 2 weeks after booster vaccination, which was in line with the observations of a previous study [ 14 ]; however, the antibody response was comparable between the enhanced GC3111 group and the positive control group with respect to all antigens and all time points (Fig. 2 B).…”

Section: Discussionsupporting

confidence: 92%

“…Since 2000, a serological study in Korea has confirmed incidents of pertussis infection with higher certainty than reported earlier, and small-scale pertussis outbreaks have occurred once every 3 years since 2009, leading to the requirement for Tdap vaccination. In 2010, GC Pharma, a national company, started developing Tdap and DTaP vaccines; and our laboratory, the Vaccine Bio Research Institute, conducted animal-based studies [ 15 , 16 ] and performed clinical trials [ 14 ] using the Tdap booster vaccine. In animal studies, GC Pharma’s new Tdap vaccine, GC3111, was compared with Boostrix™, a commercially available product in Korea.…”

Section: Discussionmentioning

confidence: 99%

“…To resolve this issue, Green Cross Pharma (GC Pharma, Yongin, Korea) began developing a Tdap vaccine (GC3111) in 2010 and began Phase I and IIa clinical trials in 2017. During the trials, the antibody titre against PT, filamentous hemagglutinin antigen (FHA), and PRN antigens revealed positive seroconversion and seroprotection after vaccination; however, the vaccine induced a lower titre level of the antibody to FHA compared to the commercially available control vaccine Boostrix™ (GlaxoSmithKlein, Rixensart, Belgium) [ 14 ]. Based on this finding, an enhanced GC3111 Tdap vaccine with increased antigen volume was developed by improving FHA inactivation and purification.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Immunogenicity of a new enhanced tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine against Bordetella pertussis in a murine model

et al. 2021

Self Cite

View full text Add to dashboard Cite

Background The necessity of the tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine in adolescence and adults has been emphasized since the resurgence of small-scale pertussis in Korea and worldwide due to the waning effect of the vaccine and variant pathogenic stains in the late 1990s. GreenCross Pharma (GC Pharma), a Korean company, developed the Tdap vaccine GC3111 in 2010. Recently, they enhanced the vaccine, GC3111, produced previously in 2010 to reinforce the antibody response against filamentous hemagglutinin (FHA). In this study, immunogenicity and efficacy of the enhanced Tdap vaccine compared and evaluated with two Tdap vaccines, GC3111 vaccine produced in 2010 previously and commercially available Tdap vaccine in a murine model. Methods Two tests groups and positive control group of Balb/c mice were primed with two doses of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine followed by a single booster Tdap vaccine at 9 week using the commercially available Tdap vaccine or 2 Tdap vaccines from GC Pharma (GC3111, enhanced GC3111). Humoral response was assessed 1 week before and 2 and 4 weeks after Tdap booster vaccination. The enhanced GC3111 generated similar humoral response compare to the commercial vaccine for filamentous hemagglutinin (FHA). The interferon gamma (IFN-γ) (Th1), interleukin 5 (IL-5) (Th2) and interleukin 17 (IL-17) (Th17) cytokines were assessed 4 weeks after booster vaccination by stimulation with three simulators: heat inactivated Bordetella pertussis (hBp), vaccine antigens, and hBp mixed with antigens (hBp + antigen). A bacterial challenge test was performed 4 weeks after booster vaccination. Results Regarding cell-mediated immunity, cytokine secretion differed among the three simulators. However, no difference was found between two test groups and positive control group. All the vaccinated groups indicated a Th1 or Th1/Th2 response. On Day 5 post-bacterial challenge, B. pertussis colonies were absent in the lungs in two test groups and positive control group. Conclusions Our results confirmed the immunogenicity of GC Pharma’s Tdap vaccine; enhanced GC3111 was equivalent to the presently used commercial vaccine in terms of humoral response as well as cell-mediated cytokine expression.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Immunogenicity of a new enhanced tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine against Bordetella pertussis in a murine model

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

“…Thus, evaluation of humoral response after pertussis vaccination is immensely signi cant. In this study, compared to the positive control, the GC3111 group showed a signi cantly lower anti-FHA antibody level 2 weeks after booster vaccination, which was in line with the observations of a previous study [13]; however, the antibody response was comparable between the enhanced GC3111 group and the positive control group with respect to all antigens and all time points (Fig. 2B).…”

Section: Discussionsupporting

confidence: 92%

“…Since 2000, a serological study in Korea has con rmed incidents of pertussis infection with higher certainty than reported earlier, and small-scale pertussis outbreaks have occurred once every 3 years since 2009, leading to the requirement for Tdap vaccination. In 2010, GC Pharma, a national company, started developing Tdap and DTaP vaccines; and our laboratory, the Vaccine Bio Research Institute, conducted animal-based studies [11,12] and performed clinical trials [13] using the Tdap booster vaccine. In animal studies, GC Pharma's new Tdap vaccine, GC3111, was compared with Boostrix™, a commercially available product in Korea.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of a New Enhanced Tetanus-reduced Dose Diphtheria-acellular Pertussis (Tdap) Vaccine Against Bordetella Pertussis in a Murine Model

Kang

Huh

Kim

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

BackgroundThe necessity of the tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine in adolescence and adults has been emphasized since the resurgence of small-scale pertussis in Korea and worldwide due to the waning effect of the vaccine and variant pathogenic stains in the late 1990s. GreenCross Pharma (GC Pharma), a Korean company, developed the Tdap vaccine GC3111 in 2010. Recently, they enhanced the former vaccine GC3111 to reinforce the antibody response against filamentous hemagglutinin (FHA). In this study, the immunogenicity and efficacy of the enhanced Tdap vaccine were compared and evaluated between the former Tdap vaccine GC3111 and the commercially available Tdap vaccine in a murine model.MethodsBalb/C mice were primed with two doses of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine followed by a single booster Tdap vaccine at 6 weeks using the commercially available Tdap vaccine or 2 Tdap vaccines from GC Pharma (GC3111, enhanced GC3111). Humoral response was assessed 1 week before and 2 and 4 weeks after Tdap booster vaccination. The INF-γ (Th1), IL-5 (Th2), and IL-17 (Th17) cytokines were assessed 4 weeks after booster vaccination by stimulation with three simulators: heat inactivated Bordetella pertussis (hBp), vaccine antigens, and hBp mixed with antigens. An intranasal challenge test was performed 4 weeks after booster vaccination.ResultsThe enhanced GC3111 generated a humoral response to filamentous hemagglutinin (FHA) that was comparable to that of the commercial vaccine. Regarding cell-mediated immunity, cytokine secretion differed among the three simulators. However, no difference was found between the groups. All the vaccinated groups indicated a Th1/Th2 response. The mean value of INF-γ in the control and study groups (simulated with hBp mixed with antigens) was 12,551.69, and the mean value of IL-5 (simulated with antigens) was 1,782.47 pg/mL. On Day 5 post-intranasal challenge, B. pertussis colonies were absent in the lungs in all groups.ConclusionsOur results confirmed the immunogenicity of GC Pharma’s Tdap vaccine; enhanced GC3111 was equivalent to the presently used commercial vaccine in terms of humoral response as well as cell-mediated cytokine expression.

show abstract

Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the ‘D-Kids’ study protocol

Binks,

Bleakley,

Pizzutto

et al. 2023

BMJ Open Resp Res

View full text Add to dashboard Cite

IntroductionGlobally, acute respiratory infections (ARIs) are a leading cause of childhood morbidity and mortality. While ARI-related mortality is low in Australia, First Nations infants are hospitalised with ARIs up to nine times more often than their non-First Nations counterparts. The gap is widest in the Northern Territory (NT) where rates of both acute and chronic respiratory infection are among the highest reported in the world. Vitamin D deficiency is common among NT First Nations neonates and associated with an increased risk of ARI hospitalisation. We hypothesise that perinatal vitamin D supplementation will reduce the risk of ARI in the first year of life.Methods and analysis‘D-Kids’ is a parallel (1:1), double-blind (allocation concealed), randomised placebo-controlled trial conducted among NT First Nations mother–infant pairs. Pregnant women and their babies (n=314) receive either vitamin D or placebo. Women receive 14 000 IU/week or placebo from 28 to 34 weeks gestation until birth and babies receive 4200 IU/week or placebo from birth until age 4 months. The primary outcome is the incidence of ARI episodes receiving medical attention in the first year of life. Secondary outcomes include circulating vitamin D level and nasal pathogen prevalence. Tertiary outcomes include infant immune cell phenotypes and challenge responses. Blood, nasal swabs, breast milk and saliva are collected longitudinally across four study visits: enrolment, birth, infant age 4 and 12 months. The sample size provides 90% power to detect a 27.5% relative reduction in new ARI episodes between groups.Ethics and disseminationThis trial is approved by the NT Human Research Ethics Committee (2018-3160). Study outcomes will be disseminated to participant families, communities, local policy-makers, the broader research and clinical community via written and oral reports, education workshops, peer-reviewed journals, national and international conferences.Trial registration numberACTRN12618001174279.

show abstract

Development and implementation of standardized method for detecting immunogenicity of acellular pertussis vaccines in Korea

Cited by 6 publications

References 23 publications

Immunogenicity of a new enhanced tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine against Bordetella pertussis in a murine model

Immunogenicity of a new enhanced tetanus-reduced dose diphtheria-acellular pertussis (Tdap) vaccine against Bordetella pertussis in a murine model

Immunogenicity of a New Enhanced Tetanus-reduced Dose Diphtheria-acellular Pertussis (Tdap) Vaccine Against Bordetella Pertussis in a Murine Model

Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the ‘D-Kids’ study protocol

Contact Info

Product

Resources

About