• Clinical and Experimental Pediatrics
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• v.63 no.7
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• pp.265-271
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• 2020

Background: Pneumococcal diseases among children aged <5 years worldwide are associated with high annual mortality rates. Purpose: This study aimed to evaluate the immunogenicity and safety of GBP411, a 12-valent pneumococcal conjugant vaccine, with a dosing schedule of 2 primary doses plus 1 booster dose (2p+1) in healthy infants. Methods: This randomized active-controlled (Prevnar 13) double-blind phase 2 trial enrolled healthy subjects aged 6-10 weeks. Three serum concentrations of pneumococcal serotype-specific immunoglobulin G (IgG) were evaluated using the pneumococcal serotype-specific pneumonia polysaccharide enzyme-linked immunosorbent assay at 1 month after the primary doses and before and 1 month after the booster dose. The pneumococcal serotype-specific IgG titer was evaluated using a multiplex opsonophagocytic assay in a subset of 15 subjects per group. Results: After administration of the primary doses, the proportion of subjects who achieved pneumococcal serotype-specific IgG concentrations of >0.35 ㎍/mL was lower for some serotypes in the GBP411 group than in the comparator group (6B: 20.83% vs. 39.22%, P=0.047 and 19A: 58.33% vs. 90.20%, P<0.001). However, after administration of the booster dose, >97% of the subjects in each group achieved IgG concentrations of ≥0.35 ㎍/mL for all 12 serotypes. Increased immunogenicity was observed for some serotypes that showed significant intergroup differences after administration of the primary doses but not after the booster dose. We also found no significant intergroup difference in the overall incidence of solicited local adverse events. Furthermore, the overall incidence of solicited systemic adverse events was significantly lower in the GBP411 group than in the comparator vaccine group (79.59% vs. 98.04%; P=0.003). Conclusion: The GBP411 vaccine with a dosing schedule of 2p+1 may be immunogenic and safe for healthy infants.

• Clinical and Experimental Vaccine Research
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• v.13 no.2
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• pp.83-90
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• 2024

The emergence of coronavirus disease 2019 (COVID-19) vaccines has been a remarkable advancement. However, the efficacy, immunogenicity, and safety of these vaccines in individuals with liver cirrhosis require careful evaluation due to their compromised immune status and potential interactions with underlying liver disease. The present study aimed to evaluate the safety and efficacy of COVID-19 vaccines in liver cirrhosis patients. In the present study, we searched international databases, including Google Scholar, PubMed, Scopus, Embase, and Web of Science. The search strategy was carried out by using keywords and MeSH (Medical Subject Headings) terms. STATA ver. 15.0 (Stata Corp., USA) was used to analyze the data statistically. The analysis was performed using the randomeffects model. We also used the chi-square test and I² index to calculate heterogeneity among studies. For evaluating publication bias, Begg's funnel plots and Egger's tests were used. A total of 4,831 liver cirrhosis patients with COVID-19 were examined from 11 studies. The rate of hospitalization in the patients with liver cirrhosis was 17.6% (95% confidence interval [CI], 9%-44%). The rate of fever in the patients with liver cirrhosis was 4.5% (95% CI, 0.9%-8.1%). The rate of positive neutralizing antibodies in the patients with liver cirrhosis was 82.5% (95% CI, 69.8%-95.1%). Also, the rates of seroconversion after the second vaccination in patients with liver cirrhosis and the control group were 96.6% (95% CI, 92.0%-99.0%), and 99.7% (95% CI, 99.0%-100.0%), respectively. COVID-19 vaccines have demonstrated promising efficacy, immunogenicity, and safety profiles in individuals with liver cirrhosis, providing crucial protection against COVID-19-related complications.

• Proceedings of the Korean Society of Fisheries Technology Conference
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• 2003.05a
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• pp.313-314
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• 2003

Antiviral DNA vaccine carrying a gene for a major antigenic viral protein have received considerable attention as a new approach in vaccine development. For fish viruses effects of DNA vaccine encoding viral G gene of infectious hematopoietic necrosis virus(IHNV) and viral hemorrhagic septicemia virus (VHSV)have been demonst.ated previously(Lapatra et al., 2001) Hirame rhabdovirus (HIRRV) causes hemorragic disease on flounder. (omitted)

• Korean Journal of Veterinary Research
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• v.51 no.1
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• pp.21-28
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• 2011

Salmonella Enteritidis (SE) has been a major causative agent of food-borne human disease due to consumption of contaminated eggs and poultry meat. To prevent SE infection in poultry, and therefore minimize human infections, vaccination with either killed or live SE vaccine is suggested. We evaluated a newly developed killed bacterin using a representative SE isolate in Korea. Among pool of SE isolates, two highly virulent isolates (the one isolate from chicken, the other from human) were selected by measuring mortality in mouse and chickens administered. The chickens were injected intramuscularly with killed vaccine and were challenged with highly virulent SE strain 3 week after vaccination. The recovered colony count (cfu/g) of spleen and cecal content in the vaccinated groups was reduced compared with those of the unvaccinated control group. The antibody level in the vaccinated groups was higher at 3 week post vaccination. These results indicate that vaccination with killed vaccine was effective in preventing the infection of virulent SE. Further study for a large number of layers should be needed for the effect of egg production, SE shedding in feces, persistence of antibody level.

• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.1-14
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• 2004

A promising approach to the development of a new single-step vaccine, which would eliminate the requirement for multiple injections, involves the encapsulation of antigens into microspheres. Biodegradable poly(lactide-co-glycolide) (PLGA) microspheres gave us a bright insight for controling antigen release in a pulsatile fashion, thereby mimicking two or tree boosting injections. However, in spite of the above merits, the level of immunization induced by a single-shot vaccination is often lower tan two doses of alum-adsorbed antigen. Therefore, optima modification of the microsphere is essential for the development of single-step vaccines. In the review, we discuss the stability of antigen in microsphere, safety and non-toxic in human and encapsulation technology. Also, we attempted to outline relevant physicochemical properties on the immunogenicity of microsphere vaccine and attainment of pulsatile release pater by combination of different microsphere, as well as to analyze immunological data associated with antigen delivery by microsphere. Although a lot of variables are related to the optimized microsphere formulation, we could conclude that judicious choice of proper polymer type, adjustment of particles size, and appropriate immunization protocol along with a suitable adjuvant might be a crucial factor for the generation of long-lasting immune response from a single-step vaccine formulation employing PLGA microsphere.

• Clinical and Experimental Pediatrics
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• v.50 no.4
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• pp.355-362
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• 2007

Purpose : We conducted the study to evaluate the immunogenicity and safety of three component DTaP vaccine ($Infanrix^{(R)}$) in a group of Korean healthy infants on a three-dose primary vaccination. And we compared the immunogenicity of this DTaP vaccine with two component DTaP vaccine which has been widely used in Korea. Methods : We enrolled one hundred fifty one healthy infants aged 8-9 weeks. These infants were vaccinated at age 2, 4 and 6 months of age with three component DTaP vaccine. Solicited adverse events were actively monitored for 72 hours following each vaccination, and all adverse events after each vaccination were observed for three weeks. Anti-diphtheria toxoid Ab., anti-tetanus toxoid Ab., anti-pertussis toxin Ab., anti-filamentous hemagglutinin Ab., and anti-pertactin Ab. were measured using ELISA for assessing immunogenicity of study vaccine in 60 infants. Immunogenicity analysis of two component DTaP vaccine was performed with same methods in 14 infants as control. Results : The seroconversion rates of anti-diphtheria toxoid Ab, anti-tetanus toxoid Ab. anti-filamentous hemagglutinin Ab. were 100% in both group. Seroconversion rate of anti-pertactin Ab in study group was 100%, but the rate in control group was 50%. However, geometric mean concentration of anti-pertussis toxin Ab. was higher in control group. Mild local and systemic reactions were observed within three days after vaccination, and no serious adverse events related study vaccine were happened during study period. Conclusion : Our study results suggest that three component DTaP vaccine ($Infanrix^{(R)}$) is a well-tolerable and high immunogenic vaccine, especially anti-Pertactin Ab. of the study vaccine is very immunogenic. It can be available as routine DTaP vaccination in our infants.

• Korean Journal of Veterinary Research
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• v.26 no.1
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• pp.103-108
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• 1986

The oil emulsion and alhydrogel pilli vaccines were prepared from a strain(O9: K35, K99, F41) of enterotoxigenic Escherichia coli isolated from calves with diarrhea and their immunogenicity was tested in guinea-pigs, pregnant goats and cows. Serum antibody responses to K99 and F41 antigens in guinea-pigs given experimental oil and gel vaccines peaked at 4 and 6 weeks after vaccinations. At that time, the mean hemagglutination inhibition titers to K99 and F41 antigens in guinea-pigs given oil vaccine were 1:25 and 1:1, 218 and those given gel vaccine were 1:54 and 1:724 respectively. Agglutinin titers in pregnant goats given the oil vaccine were significantly higher(mean 1:2,347) compared to those of control group(mean 1:160). Less than 12.5% of goatlings from vaccinated goats developed scours compared to nearly 100% in control group after oral challenge with enterotoxigenic Escherichia coil within 24 hours after birth. The highest agglutinin titers of cow serum and colostrum and of the serum of calves 48 hours after birth from cows given oil vaccine were 1:256, 1:512 and 1:64 respectively. On the other hand, those titers of serum and colostrum and of the serum of nursing calves from nonvaccinated cows were 1:8, 1:16 and 1:20 respectively. The protective efficacy of the oil emulsion vaccine was 72.1% under field conditions. These results strongly indicated that the vaccine could be applied for protection of diarrhea caused by enterotoxigenic Escherichia coli in calves.

• Proceedings of the Microbiological Society of Korea Conference
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• 2009.05a
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• pp.72-73
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• 2009

• Korean Journal of Veterinary Research
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• v.35 no.4
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• pp.753-758
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• 1995

The study was carried out to investigate the pathogenicity of EHV isolate to hamsters and mice and immunogenicity of experimentally produced. vaccine were evaluated in the horses. Hamsters infected. intranasally with $LC_1$ isolate showed symptoms of nasal discharge, conjunctivitis and body weight loss during the observation period of 12 days after infection, while only slight depression and body weight loss were noticed with mice infected with $LC_1$ indicating that hamsters are more susceptible to the virus. Antibody titer of mice and hamsters were gradually increased to highest level of 1:2560~10240, 1:640~1280, respectively, at 7~12 days post vaccination. Horses immunized against $LC_1$ killed vaccine reached to maximum antibody titer of 1:20480 around 4 weeks after 1st vaccination and declined after 12 weeks post vaccination. No significant antibody increase were detected after 2nd vaccination. Mean body temperature and mean total leukocyte counts remained within normal range and no adverse reaction were noticed after vaccination.

• Clinical and Experimental Vaccine Research
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• v.12 no.2
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• pp.107-115
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• 2023

Purpose: The present study aimed to study the immunogenicity of the ChAdOx1 nCoV-19 vaccine in patients with hematologic malignancies. Materials and Methods: This prospective cohort study of hematology patients aimed to evaluate their antibody levels against the receptor-binding domain of the severe acute respiratory syndrome coronavirus 2 spike protein and seroconversion rates following two doses of the ChAdOx1 nCoV-19 vaccine. Between June and July 2021, we enrolled 61 patients and included 44 patients in our analysis. Antibody levels were assessed 8 and 4 weeks after the first and second injections, respectively, and compared with those of a healthy group. Results: Eight weeks after the first dose, the geometric mean antibody level was 1.02 binding antibody units (BAU)/mL in the patient group and 37.91 BAU/mL in the healthy volunteer group (p<0.01). Four weeks after the second dose, the geometric mean antibody level was 9.44 BAU/mL in patients and 641.6 BAU/mL in healthy volunteers (p<0.01). The seroconversion rates 8 weeks after the first dose were 27.27% and 98.86% in the patient and healthy volunteer groups, respectively (p<0.001). The seroconversion rate 4 weeks after the second dose was 47.73% in patients and 100% in healthy volunteers. Factors leading to lower seroconversion rates were rituximab therapy (p=0.002), steroid therapy (p<0.001), and ongoing chemotherapy (p=0.048). Factors that decreased antibody levels were hematologic cancer (p<0.001), ongoing chemotherapy (p=0.004), rituximab (p<0.001), steroid use (p<0.001), and absolute lymphocyte count <1,000/mm³ (p=0.009). Conclusion: Immune responses were impaired in individuals with hematologic malignancies, particularly patients undergoing ongoing therapy and B-cell-depleting therapy. Additional vaccinations should be considered for these patients, and further investigated.