This research and development of MenB meningococcal vaccines includes two technical routes: outer membrane vesicle (OMV) vaccines and recombinant protein vaccines. This article intends to review the development, production and application of MenB meningococcal OMV vaccines in order to provide a reference for the development of MenB meningococcal OMV vaccine in China.
Antigens, Bacterial ; Humans ; Meningococcal Infections/prevention & control* ; Meningococcal Vaccines ; Neisseria meningitidis, Serogroup B ; Serogroup ; Vaccines, Synthetic

Objective: To evaluate the immunogenicity of group A+C meningococcal polysaccharide conjugate vaccine in infants under 2 years old. Methods: From March 2017 to June 2018, 1 932 healthy infants in Biyang County, Henan Province, who were not vaccinated with meningococcal meningitis vaccine and whose axillary temperature was ≤37.0 ℃, were recruited as participants. The 3 months and 6-11 months old infants were allocated to the experiment group and the control group in a ratio of 1∶1. Infants aged 12-23 months were allocated to the 1-dose group, the 2-dose group and the control group in a ratio of 1∶1∶1, with 276 infants in each group. The infants in the experiment group were intramuscularly injected with freeze-dried group A+C meningococcal polysaccharide conjugate vaccine to be evaluated, and infants in the control group received intramuscular injection of commercially available freeze-dried group A+C meningococcal conjugate vaccine. The venous blood of infants was collected 30 days before the first dose and after the last dose of inoculation, and the antibody seroconversion of each group was determined and compared. Results: The completion rate of immunogenicity study was 95.2% (1 839/1 932). Before inoculation, there was no statistical difference in the geometric mean titer and positive rate of group A+C antibodies between the experiment group and the control group in 3 months and 6-11 months old infants (all P values >0.05). The geometric mean titers and positive rate of group A antibodies in the 1-dose group were higher than those in the control group (all P values <0.05), but there was no statistical difference between the 2-dose group and the control group (all P values >0.05) in infants aged 12-23 months. After inoculation, the differences (95%CI) in the positive conversion rate of group A+C antibodies between the experiment group and the control group were -0.12% (-6.01%-5.77%) and 0.82% (-4.23%-5.86%) in the 3 months old infants. At the age of 6-11 months, the differences were 6.75% (1.71%-11.79%) and -4.32% (-8.73%-0.08%), respectively. At the age of 12-23 months, the differences were 1.02% (-3.80%-5.83%) and -4.40% (-7.79%- -1.01%) in the 2-dose group and -7.22% (-12.90%- -1.54%) and -18.61% (-23.75%- -13.46%) in the 1-dose group, respectively. The geometric mean titers of group A+C antibodies in the 3 months old infants were 48.50 and 63.12, respectively, which had no significant difference from the control group (43.02 and 57.99, respectively) (both P values <0.05). The geometric mean titers of group A+C antibodies in the 6-11 months and 12-23 months old infants were 84.09 and 92.51 (2-dose group), which were higher than those in the corresponding control group (43.10 and 61.83, respectively) (all P values <0.001). Conclusion: Group A+C meningococcal conjugate vaccine has good immunogenicity in infants under 2 years old.
Humans ; Infant ; Child, Preschool ; Meningococcal Vaccines ; Vaccines, Conjugate ; Vaccination ; Neisseria meningitidis ; Polysaccharides ; Antibodies, Bacterial

This article reviews recent data on meningococcal disease and carriage in the Philippines. It aims to provide information on the epidemiology of meningococcal disease, its carriage, data on prevention, and the impact of vaccination on disease and carriage. The World Health Organization considers the Philippines as having low endemicity for meningococcal disease. However, current data underestimates the true burden in the country due to many factors. In recent years, data from the Philippines show a high case-fatality rate since only the septicemic form is being reported. Studies on asymptomatic meningococcal carriage rates are sparse, with one study by Gonzales, et al. investigating the prevalence of meningococcal nasopharyngeal carriage in Filipinos aged 5-24 years old living in an urban setting. The study showed that the overall prevalence of carriage was 3.7% and was highest (9%) among the 10-14 age group. Serogroup B was the most common isolate. Effective meningococcal vaccines are available. Although not included in the National Immunization Program, medical societies recommend giving vaccines to individuals at high risk of infection. Data on local epidemiology accounting for the disease and asymptomatic carriage are important to strengthen future programs on immunization and prevention of meningococcal disease.
Meningococcal Infections ; Meningococcal Vaccines

Epidemic cerebrospinal meningitis (meningococcal meningitis) is an acute respiratory infectious disease with high mortality and serious sequelae. Meningococcal vaccine is an effective measure to prevent and control meningococcal meningitis. At present, group B meningococcal meningitis has become the main prevalent serum group in the world, including China. Meningococcal ACYW and other vaccines are mainly composed of capsular polysaccharides, while the main component of group B meningococcal vaccine is protein, including outer membrane vesicles (OMV) and recombinant protein vaccine. The methods for evaluating the immunogenicity of group B meningococcal vaccine include hSBA and alternative methods such as meningococcal antigen typing system (MATS), flow cytometric meningococcal antigen surface expression assay (MEASURE), genetic meningococcal antigen typing system (gMATS) and bexsero antigen sequence type (BAST). The evaluation of vaccine immunogenicity is the basis of vaccine development and clinical trial research, However, at present, there is no group B meningococcal vaccine in China. Therefore, in this paper, the research progress of immunogenicity evaluation of group B meningococcal vaccine has been reviewed, in order to provide technical guidance for the research and development of group B meningococcal vaccine, immunogenicity evaluation and clinical trial research in China.
Humans ; Meningitis, Meningococcal/prevention & control* ; Meningococcal Vaccines ; Neisseria meningitidis ; Serogroup ; Vaccines, Combined

The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
Antibodies, Bacterial ; Humans ; Infant ; Meningococcal Vaccines ; adverse effects ; immunology ; Vaccines, Conjugate

BACKGROUND: After the introduction of the meningococcal ACWY-CRM197 conjugate vaccine (MenACWY-CRM) in 2012 and the meningococcal ACWY-diphtheria toxoid conjugate vaccine (MenACWY-DT) in 2014, immunization was recommended for certain high-risk groups including new military recruits in Korea. However, comparative immunogenicity studies for these vaccines have not been performed in Korea. Here, we compared the immunogenicity of these two vaccines in healthy adults. METHODS: A total of 64 adults, 20–49 years of age, were randomly divided into two groups (1:1) to receive either of the two vaccines. The sera were obtained before and 1 month after vaccination and tested for serogroup-specific serum bactericidal activity using baby rabbit complement. RESULTS: There were no significant differences post-vaccination in the geometric mean indices and the seropositive rate to all serogroups between the vaccines. The proportion of seropositive subjects after vaccination ranged from 88% to 100%. CONCLUSION: Both meningococcal conjugate vaccines showed good immunogenicity in healthy Korean adults without statistically significant differences. Further investigations for serotype distribution of circulating meningococci and the immune interference between other diphtheria toxin-containing vaccines concomitantly used for military recruits are needed to optimize immunization policies. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0002460
Adult ; Complement System Proteins ; Diphtheria ; Humans ; Immunization ; Information Services ; Korea ; Meningococcal Vaccines ; Military Personnel ; Serogroup ; Vaccination ; Vaccines ; Vaccines, Conjugate

Meningococcal vaccines in the Chinese market include meningococcal polysaccharide vaccine, meningococcal polysaccharide conjugate vaccine, and a combined vaccine. Meningococcal conjugate vaccines immunization schedules vary by vaccine manufacturer, and often cause confusion in immunization practices. Based on the epidemiological characteristics of meningococcal disease, serogroup distribution of Neisseria meningitidis, and research progress on the immunogenicity and safety of meningococcal vaccines, we developed an experts' consensus on immunization with meningococcal vaccines to provide guidance for immunization providers and for centers for disease control and prevention staff.
China ; Consensus ; Humans ; Immunization ; Meningococcal Infections/prevention & control* ; Meningococcal Vaccines/administration & dosage* ; Vaccines, Conjugate

Meningococcal meningitis is an acute, severe respiratory infectious disease caused by Neisseria meningitidis. Immunization with meningococcal vaccine is the most effective measure to control and prevent transmission of meningococcal meningitis. Meningococcal vaccines in the Chinese market include meningococcal polysaccharide vaccine, meningococcal polysaccharide conjugate vaccine, and a combined vaccine containing meningococcal polysaccharide conjugate vaccine. This article reviews research progress on the efficacy, safety, and cost-effectiveness of meningococcal vaccines, particularly in the Chinese market, to support appropriate use of the various meningococcal vaccines for preventing meningococcal meningitis.
Cost-Benefit Analysis ; Humans ; Immunization/economics* ; Meningitis, Meningococcal/prevention & control* ; Meningococcal Vaccines/immunology* ; Vaccination/economics* ; Vaccines, Conjugate/immunology*

The meningococcus carriage rate is age-dependent, with a high prevalence in adolescents and young adults. This cross-sectional study aimed to estimate the oropharyngeal carriage rate of meningococcus among healthy Korean adolescents and its relationship with several population characteristics. The survey was conducted from April to May 2015 among 1,460 first-year high-school students in 9 high schools located in Gyeonggi province, Korea. Each student answered a short questionnaire assessing risk factors for carriage, and posterior pharyngeal wall swab samples were obtained. These samples were cultured on meningococcus-selective media, with colonies resembling meningococci identified using the Vitek® MS system (bioMérieux, Marcy l'Etoile, France). All isolates were characterized by molecular serogrouping and multilocus sequence typing (MLST). Meningococci were identified from 3.4% (49/1,460) swabs. Current smokers had significantly higher carriage rates than non-smokers (8.2% vs. 2.9%, P = 0.002), and boys had significantly higher carriage rates than girls (4.4% vs. 1.6%, P = 0.004). Serogroup B was the most common serogroup, followed by serogroup C, then 29E and Y. Twenty-seven different sequence types (STs) were identified; the most common were ST-3091, ST-11278, and ST-44. These belonged to clonal complexes (CCs) 269, 32, and 41/44, respectively, known as the hypervirulent clones. Evaluating meningococcal carriage is important to understand the epidemiology of meningococcal disease; however, little data exist in Korea. Similar to western countries, meningococcal serogroup B has emerged in Korea, and hypervirulent clones were identified. It is necessary to monitor the genetic and serologic characteristics of circulating meningococci and to assess the potential strain coverage of meningococcal vaccines.
Adolescent* ; Carrier State ; Clone Cells ; Cross-Sectional Studies ; Epidemiology ; Female ; Gyeonggi-do ; Humans ; Korea ; Meningococcal Vaccines ; Multilocus Sequence Typing ; Neisseria meningitidis* ; Neisseria* ; Population Characteristics ; Prevalence ; Risk Factors ; Serogroup ; Young Adult

The quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) has been introduced for military recruits in Korea since 2012. This study was performed to evaluate the immunogenicity of MenACWY-CRM in Korean military recruits. In addition, the influence of tetanus-diphtheria toxoids (Td) vaccination on the vaccine response to MenACWY-CRM was analyzed. A total of 75 military recruits were enrolled. Among them, 18 received a dose of MenACWY-CRM only (group 1), and 57 received Td three days before MenACWY-CRM immunization (group 2). The immunogenicity of MenACWY-CRM was compared between the two groups. The serum bactericidal activity with baby rabbit complement was measured before and three weeks after immunization against serogroups A, C, W-135, and Y. The geometric mean titers (GMTs) against four serogroups were significantly increased in both groups after immunization. Compared to group 2, group 1 exhibited significantly higher vaccine responses in several aspects: post-immune GMTs against serogroup A and C, seroresponse rates against serogroup A, and a fold increases of titers against serogroup A, C, and Y. MenACWY-CRM was immunogenic against all vaccine-serogroups in Korean military recruits. Vaccine response to MenACWY-CRM was influenced by Td administered three days earlier.
Complement System Proteins ; Humans ; Immunization ; Korea ; Meningococcal Vaccines ; Military Personnel* ; Neisseria meningitidis ; Serogroup ; Serum Bactericidal Antibody Assay ; Toxoids ; Vaccination*