One-year antibody persistence and safety of a 4-dose schedule of MenACWY-CRM in healthy infants from South Korea

이환종,조대선,김윤경,이현주,김경효,이도경,Carlo Curina,Marco Costantini,Silvia Barbi,Yan Miao,Michele Pellegrini 대한백신학회 2019 Clinical and Experimental Vaccine Research Vol.8 No.2

Purpose: Results from a post-marketing study to generate evidence on 1-year antibody persistence and safety following vaccination of infants from South Korea with the quadrivalent meningococcal conjugate vaccine MenACWY-CRM. Materials and Methods: In this phase IV, open-label, multi-center study (NCT02446691), 128 infants received MenACWY-CRM at ages 2, 4, 6, and 12 months. One-year antibody persistence following the full vaccination course was evaluated (primary objective) for the four meningococcal serogroups (Men) by serum bactericidal activity assay using human or rabbit complement (hSBA/rSBA). Immune responses at 1-month post-vaccination and safety were also assessed. Results: The percentage of children with hSBA titers ≥8 ranged between 94% (MenA) and 100% (MenY/W) 1-month post-vaccination, and from 39% (MenA) to 89% (MenY) 1-year post-vaccination. At least 99% and 92% of children had rSBA titers ≥8 and ≥128 against each meningococcal serogroup, 1-month post-vaccination. One-year post-vaccination, the percentage of children with rSBA titers ≥8 and ≥128 ranged from 54% (MenC) to 99% (MenA) and from 30% (MenC) to 98% (MenA). Geometric mean titers declined from 1-month to 1-year post-vaccination, when they varied between 6.8 (MenA) and 53.6 (MenW) by hSBA and between 17.2 (MenC) and 2,269.5 (MenA) by rSBA. At least one solicited and unsolicited adverse event was reported for 79% and 66% of children. Of 36 serious adverse events reported, none were vaccination-related. Conclusion: Antibody persistence (hSBA/rSBA titers ≥8) was determined in 39%-99% of children 1 year after a 4-dose MenACWY-CRM series during infancy, with an acceptable clinical safety profile.

Comparative evaluation of gold nanoparticles and Alum as immune enhancers against rabies vaccine and related immune reactivity, physiological, and histopathological alterations: in vivo study

Sahar Mohamed Mahmoud 대한백신학회 2023 Clinical and Experimental Vaccine Research Vol.12 No.1

Purpose: The present study aimed to compare the immune-enhancing potential of gold nanoparticles (AuNPs) to Alum against rabies vaccine and the related immunological, physiological, and histopathological effects. Materials and Methods: Alum and AuNPs sole and in combination with rabies vaccine were used at 0.35 mg/mL and 40 nM/mL, respectively. Rats used were categorized into six groups (20/each): control rats, rabies vaccine, aluminum phosphate gel, rabies vaccine adsorbed to Alum, AuNPs, and rabies vaccine adjuvant AuNPs. Results: Liver and kidney functions were in the normal range after AuNPs and Alum adjuvanted vaccine compared to control. Interleukin-6 and interferon-γ levels were significantly increased in groups immunized with Alum and AuNPs adjuvanted vaccine, the peak level was in the case of AuNP adjuvanted vaccine on the 14th day. Ninety days post-vaccination, total immunoglobulin G (IgG) against adjuvanted rabies vaccine showed a significantly elevated anti-rabies IgG with AuNPs and Alum adsorbed vaccine compared with unadjuvanted one. The total antioxidant capacity, malondialdehyde (MDA) levels, superoxide dismutase, and glutathione peroxidase activities were significantly increased post-adjuvanted AuNPs adjuvanted vaccine vaccination than in Alum adsorbed vaccine, while MDA was significantly decreased. The histopathological examination revealed detectable alterations post-AuNPs and Alum adjuvanted vaccine immunization compared with liver and kidney profiles post-administration of unadjuvanted and non-immunized groups, meanwhile, splenic tissue revealed hyperplasia of lymphoid follicles indicating increased immune reactivity. Conclusion: The AuNPs are promising enhancers of the immune response as Alum, and the undesirable effects of AuNPs could be managed by using suitable sizes, shapes, and concentrations.

Exploring the experience of developing COVID-19 vaccines in Iran

Kiarash Fartash 대한백신학회 2023 Clinical and Experimental Vaccine Research Vol.12 No.1

Widespread public vaccination is one of the effective mechanisms to ensure the health and prevent deaths in societies. The coronavirus disease 2019 (COVID-19) vaccine is a stark instance in this regard. Vaccine development is a complex process requiring firm-level capabilities, various infrastructures, long-term planning, and stable and efficient policies. Due to the global demand for vaccines during the pandemic, the national capability to produce vaccines is critical. To this end, the current paper investigates influential factors, at the firm- and policy-level, in the COVID-19 vaccine development process in Iran. By adopting a qualitative research method and conducting 17 semi-structured interviews and analyzing policy documents, news, and reports, we extracted internal and external factors affecting the success and failure of a vaccine development project. We also discuss the characteristics of the vaccine ecosystem and the gradual maturity of policies. This paper draws lessons for vaccine development in developing countries at both firm and policy levels.

Challenges of influenza A viruses in humans and animals and current animal vaccines as an effective control measure

Sung J. Yoo,권태용,류영수 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

Influenza A viruses (IAVs) are genetically diverse and variable pathogens that share various hosts including human, swine, and domestic poultry. Interspecies and intercontinental viral spreads make the ecology of IAV more complex. Beside endemic IAV infections, human has been exposed to pandemic and zoonotic threats from avian and swine influenza viruses. Animal health also has been threatened by high pathogenic avian influenza viruses (in domestic poultry) and reverse zoonosis (in swine). Considering its dynamic interplay between species, prevention and control against IAV should be conducted effectively in both humans and animal sectors. Vaccination is one of the most efficient tools against IAV. Numerous vaccines against animal IAVs have been developed by a variety of vaccine technologies and some of them are currently commercially available. We summarize several challenges in control of IAVs faced by human and animals and discuss IAV vaccines for animal use with those application in susceptible populations.

Efficacy of inactivated variant porcine epidemic diarrhea virus vaccines in growing pigs

이승헌,양동근,김하현,조인수 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

Purpose: The first aim of this study was to develop a novel inactivated porcine epidemic diarrhea virus (PEDV) vaccine using the recently isolated Korean PEDV QIAP1401 strain and to evaluate its protective efficacy in growing pigs. The second was to determine the optimum adjuvant formulation of the inactivated PEDV vaccine that induces protection against viral challenge. Materials and Methods: To generate high titers of infectious PEDV, the QIAP1401 isolate was passaged in Vero cells. The experimental vaccines were prepared from a binary ethyleneimine-inactivated QIAP1401 strain passaged sequentially 70 times (QIAP1401-p70), formulated with four commercial adjuvants, and administered twice intramuscularly to growing pigs. Challenge studies using a virulent homologous strain of PEDV QIAP1401-p11, which was passaged 11 times after isolation, were performed to assess protection against disease progression and viral shedding during the 15-day observation period. The vaccine-induced antibody responses were measured in serum samples collected at predetermined time points by indirect enzyme-linked immunosorbent assay and virus neutralization test. Results: The QIAP1401-p70 strain had 42 amino acid (aa) mutations, including a 25 aa deletion, and was selected as the inactivated PEDV vaccine candidate. Although none of the pigs that received the experimental vaccines were completely protected against subsequent viral challenge, they exhibited a significantly higher immune response than did non-vaccinated control pigs. Among the vaccine groups, the highest antibody responses were observed in the pigs that received an oil-based multiphasic water/oil/water (W/O/W) emulsion adjuvanted vaccine, which delayed the onset of clinical symptoms and viral shedding. Conclusion: A novel inactivated PEDV vaccine formulated with a W/O/W emulsion adjuvant was both immunogenic and protective against viral challenge.

Immunogenicity of the nanovaccine containing intimin recombinant protein in the BALB/c mice

Zahra Sadat Hosseini,Jafar Amani,Fahimeh Baghbani Arani,Shahram Nazarian,Mohammad Javad Motamedi,Fatemeh Shafighian 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

Purpose: Escherichia coli O157:H7 is one of the most important pathogens which create hemorrhagic colitis and hemolytic uremic syndrome in human. It is one of the most prevalent causes of diarrhea leading to death of many people every year. The first diagnosed gene in the locus of enterocyte effacement pathogenicity island is eae gene. The product of this gene is a binding protein called intimin belonging to the group of external membrane proteins regarded as a good stimulants of the immune system. Chitosan with its lipophilic property is an environmentally friendly agent able to return to the environment. Materials and Methods: Intimin recombinant protein was expressed in pET28a vector with eae gene and purification was performed using Ni-NTA and finally the recombinant protein was approved through western blotting. This protein was encapsulated using chitosan nanoparticles and the size of nanoparticles was measured by Zetasizer. Intimin encapsulated was prescribed for three sessions among three groups of oral, injection, and oral-injection using Chitosan nanoparticles. Challenge was performed for all three groups with 108E. coli O157:H7 bacteria. Results: Intimin produced by chitosan nanoparticles improves immunological responses through the adjuvant nature of chitosan nanoparticles. Chitosan may be used as a carrier for transportation of the prescribed vaccine. Among the mice, encapsulated intimin could be able to provide suitable titers of IgG and IgA by the aid of chitosan nanoparticles. Results of mice challenge showed that decreased the bacterial shedding significantly. Conclusion: Results showed that the chitosan nanovaccine with intimin protein may be used as a suitable candidate vaccine against E. coli O157:H7.

Evaluation of two different enzyme-linked immunosorbent assay for severe fever with thrombocytopenia syndrome virus diagnosis

유민아,정혜원,박수진,김영일,권혁일,김은하,시영재,유광민,Norbert John Robles,한혜정,최영기 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

To develop the large scale serological assay for severe fever with thrombocytopenia syndrome virus (SFTSV) infection, we evaluated two different enzyme-linked immunosorbent assay (ELISA) methods using nucleocapsid protein (NP) and Gn proteins of CB1 (genotype B) SFTSV strains. The NP-based ELISA tests showed more sensitive with broad cross-reactivity between two different genotype A and B strains compared with those of Gn-based ELISA tests. However, Gn-based ELISA showed more genotype specificity and specificity. These result suggested that NP-based ELISA test could be applicable for general sero-prevalence studies of SFTSV infections, while Gn-based ELISA could be applicable for a certain specific genotype sero-prevalence study.

Outbreak investigation of pertussis in an elementary school: a case-control study among vaccinated students

유석현,김준재,Meng-Yu Chen,진현주,이현경,천병철 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

Purpose: A pertussis patient from an elementary school, in Gyeonggi Province, Korea, was notified to public health authority on July 25, 2017. Epidemiologic investigation was conducted to identify the magnitude, possible source of infection and risk factors for this outbreak on August 17, 2017. Materials and Methods: A case was defined as the school student experiencing cough for more than two weeks with or without paroxysmal, whoop, or post-tussive vomiting. Control was defined as the student polymerase chain reaction-negative at the school. School based surveillance was implemented to identify additional cases. Results: From June 29 to August 27, 2017, nine patients of pertussis were identified from an elementary school. Among nine cases, eight were confirmed by polymerase chain reaction positive. All cases had cough, one (11%) had post-tussive vomiting, and one (11%) had fever. Eight cases had macrolide for 7 days in outpatient clinic, and one case admitted in a hospital. There was no significant difference of demographic factors including gender (p=0.49), age group (p=0.97), number of series of vaccination of pertussis (p=0.52), the number of participation of after school activity (p=0.28), and the time elapsed since last vaccination (p=0.42). However, we found the history of contact within the classroom or after-school activity was only the independent risk factor among all the demographic factors collected (odds ratio, 63.61; 95% confidence interval, 4.35 to 930.79). Conclusion: The contributing factor for transmission is associated with the case-contact. Immediate identification of pertussis with use of appropriate diagnostic test may help to avoid a large number of cases.

Distinct features of dendritic cell-based immunotherapy as cancer vaccines

이채린,이명미,이인무 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.1

Dendritic cells (DCs) are the most professional antigen presenting cells that play important roles in connection between innate and adaptive immune responses. Numerous studies revealed that the functions of DCs are related with the capture and processing of antigen as well as the migration to lymphoid tissues for the presenting antigens to T cells. These unique features of DCs allow them to be considered as therapeutic vaccines that can induce immune responses and anti-tumor activity. Here, we discuss and understand the immunological basis of DCs and presume the possibilities of DC-based vaccines for the promising cancer therapy.

Purification and characterization of monoclonal IgG antibodies recognizing Ebola virus glycoprotein

한백상,장호영,Trina Racine,Xiangguo Qiu,신정임 대한백신학회 2018 Clinical and Experimental Vaccine Research Vol.7 No.2

Purpose: The goal of this study was to purify and characterize Ebola virus glycoprotein (GP)-specific IgG antibodies from hybridoma clones. Materials and Methods: For hybridoma production, mice were injected by intramuscular-electroporation with GP DNA vaccines, and boosted with GP vaccines. The spleen cells were used for producing GP-specific hybridoma. Enzyme-linked immunosorbent assay, Western blot assay, flow cytometry, and virus-neutralizing assay were used to test the ability of monoclonal IgG antibodies to recognize GP and neutralize Ebola virus. Results: Twelve hybridomas, the cell supernatants of which displayed GP-binding activity by enzyme-linked immunosorbent assay and the presence of both IgG heavy and light chains by Western blot assay, were chosen as a possible IgG producer. Among these, five clones (C36-1, D11-3, D12-1, D34-2, and E140-2) were identified to secrete monoclonal IgG antibodies. When the monoclonal IgG antibodies from the 5 clones were tested for their antigen specificity, they recognized GP in an antigen-specific and IgG dose-dependent manner. They remained reactive to GP at the lowest tested concentrations (1.953-7.8 ng/mL). In particular, IgG antibodies from clones D11-3, D12-1, and E140-2 recognized the native forms of GP expressed on the cell surface. These antibodies were identified as IgG1, IgG2a, or IgG2b kappa types and appeared to recognize the native forms of GP, but not the denatured forms of GP, as determined by Western blot assay. Despite their GP-binding activity, none of the IgG antibodies neutralized Ebola virus infection in vitro, suggesting that these antibodies are unable to neutralize Ebola virus infection. Conclusion: This study shows that the purified IgG antibodies from 5 clones (C36-1, D11-3, D12-1, D34-2, and E140-2) possess GP-binding activity but not Ebola virus-neutralizing activity.