Post-marketing immunogenicity and safety of domestic 23-valent pneumococcal polysaccharide vaccine: a multicenter study / 中华微生物学和免疫学杂志

Objective:To evaluate the post-marketing safety and immunogenicity of a 23-valent pneumococcal polysaccharide vaccine (PPV23).Methods:From September 2020 to June 2021, a clinical trial of single-dose PPV23 was conducted in people ≥3 years old in Centers for Disease Control and Prevention of Guizhou, Hunan and Fujian provinces. Blood samples were collects from the subjects before and 30 d after vaccination. ELISA was used to quantitatively detect IgG antibodies against capsular polysaccharides of 23 Streptococcus pneumoniae serotypes in serum samples. The adverse events (AEs) were monitored within 7 d after vaccination. Results:A total of 409 subjects were enrolled and included in safety analysis. Except for one with antibody level inversion, the other 408 participants were included in immunogenicity analysis. The levels of antibodies against the 23 Streptococcus pneumoniae serotypes were all increased after vaccination by an average of 4.24 folds. The two-fold growth rates of the antibodies ranged from 51.72% to 96.81% with a total two-fold growth rate of 78.59%. The overall rate of AEs was 27.14% (111/409). Local AEs were mainly pain, induration, redness and swollen. No serious adverse events related to vaccination occurred. Conclusions:This study preliminarily demonstrated the good immunogenicity and safety of PPV23 vaccine.

Research progress of pneumococcal polyaccharide conjugate vaccine / 上海预防医学

Humans have been struggling for two centuries to reduce the health and economic burden caused by pneumococcal infection. Invasive pneumococcal disease （IPD）， meningitis， and acute otitis media caused by pneumococcus occur worldwide， especially in infants， children and elderly. Pneumococcus is resistant to most antibiotics and vaccines remain the most effective measure against the pneumococcal epidemic. The development of the pneumococcal vaccine was initiated at the beginning of 21 century. In 2014， incidence and mortality of pneumococcal pneumonia and IPD induced by vaccine serotypes decreased accordingly after the introduction of 13-valent pneumococcal conjugate vaccine （PCV）. Subsequently， the new challenge is to further improve the low response of some existing vaccine serotypes， include more serotypes in the PCV， and research on the application of PCV in specific populations. This review briefly describes the development of PCV.

Expert consensus on immunoprophylaxis of pneumococcal disease (2020 version) / 中华流行病学杂志

Pneumococcal disease is a serious global public health problem and a leading cause of morbidity and mortality of children and adults in China. Antibiotics are commonly used to treat pneumococcal disease. However, antibiotic resistance to Streptococcus pneumoniae has become a severe problem around the world due to widespread antibiotic use. Immunoprophylaxis of pneumococcal disease with pneumococcal vaccines is therefore of great importance. In this article, we review the etiology, clinical presentation, epidemiology, and disease burden of pneumococcal disease and the vaccinology of pneumococcal vaccines. Our review is based on the Expert Consensus on Immunoprophylaxis of Pneumococcal Disease (2017 version), the Pneumococcal Vaccines WHO Position Paper (2019), and recent national and international scientific advances. This consensus article aims to provide public health and vaccination staff with appropriate evidence for pneumococcal vaccine use and to improve professional capacity for pneumococcal disease prevention and control.

Expert consensus on immunoprophylaxis of pneumococcal disease (2020 version) / 中华预防医学杂志

Pneumococcal disease is a serious global public health problem and a leading cause of morbidity and mortality of children and adults in China. Antibiotics are commonly used to treat pneumococcal disease. However, antibiotic resistance to

Immune response in healthy elderly after inoculation with PPV23 / 上海预防医学

Objective To analyze functional antibody and protection effect against pneumonia after inoculation with 23-valent pneumococcal polysaccharide vaccine(PPV23)in healthy elderly. Methods In 2015, 48 healthy elderly people aged ≥60 years were randomly selected in Hongkou District of Shanghai, and their blood samples were collected before, and 1 month and 6 months after the inoculation of PPV23.Functional antibodies against 13 serotypes(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、23F)of streptococcus pneumonia were determined by muti-specificity opsonophagocyitosis killing assay(MOPA).The incidence of community-acquired pneumonia(CAP)after PPV23 inoculation was also investigated. Results The GMT of OPA antibodies against 13 serotypes were higher 1 and 6 months after inoculation than that before inoculation.One month after the inoculation, OPA antibodies against 13 serotypes ≥2 times growth rate and ≥4 times growth rate were 64.58%-87.00% and 43.75%-75.00%, respectively.Six months after inoculation with PPV23, OPA antibodies against 13 serotypes ≥2 times growth rate and ≥4 times growth rate were 45.71%-82.86%, 40.00%-80.00%, respectively.There was no significant difference in the growth rate of OPA antibody between 6 months and 1 month after vaccination for most serotypes.Results of self-descriptive survey before and after the inoculation showed that the protection against CAP in healthy elderly people in the first and second years after PPV23 inoculation was 100.00% and 50.00%, respectively. Conclusion PPV23 has better immunogenicity and immune persistence after inoculation in healthy elderly people, and has better protective effect against CAP.

Immunogenicity and safety of co-immunization with 23-valent pneumococcal polysaccharide vaccine and influenza virus split vaccine for children aged 3-7 years / 中华微生物学和免疫学杂志

Objective@#To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23) and trivalent influenza vaccine (TIV) in preschoolers.@*Methods@#A total of 1 035 children aged 3-7 years were enrolled in this study and randomly divided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis.@*Results@#A total of 1 035 serological specimens were collected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No significant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the concomitant vaccination group showed higher serological conversion rate of H3 type (88.75% vs 84.20%, P=0.01), but lower serological conversion rate of B type (92.84% vs 98.56%, P<0.001). There was no significant difference in the primary adverse reactions between the three groups (P=0.197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3.61%, which was higher than that of the other two groups (both P<0.001). All adverse reactions were mild or moderate, and cured after treatment.@*Conclusions@#Concomitant immunization with PPV23 and TIV is safe and have good immunogenicity, thus a viable immune strategy for susceptible children.

Immunogenicity and safety of co-immunization with 23-valent pneumococcal polysaccharide vaccine and influenza virus split vaccine for children aged 3-7 years / 中华微生物学和免疫学杂志

Objective To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine ( PPV23) and trivalent influenza vaccine ( TIV) in pre-schoolers. Methods A total of 1035 children aged 3-7 years were enrolled in this study and randomly di-vided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis. Results A total of 1035 serological specimens were col-lected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No sig-nificant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the con-comitant vaccination group showed higher serological conversion rate of H3 type (88. 75％ vs 84. 20％ , P=0. 01), but lower serological conversion rate of B type (92. 84％ vs 98. 56％ , P<0. 001). There was no significant difference in the primary adverse reactions between the three groups (P = 0. 197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3. 61％ , which was higher than that of the other two groups (both P<0. 001). All adverse reactions were mild or moderate, and cured after treatment. Conclusions Concomitant immunization with PPV23 and TIV is safe and have good immu-nogenicity, thus a viable immune strategy for susceptible children.

Expert consensus on immunization for prevention of pneumococcal disease in China (2017) / 中华流行病学杂志

Pneumococcal disease is one of the serious global public health problems, and an important leading cause of the morbidity and mortality of children and adults in China. Currently, antibiotics are the most choices for its clinical treatment. However, antibiotic resistance of has become a severe problem around the world due to the wide use of antibiotics. Hence, the prevention of pneumococcal disease by using pneumococcal vaccines is of great importance. In this article, we reviewed the etiology, clinic, epidemiology, disease burden of pneumococcal disease, and the vaccinology of pneumococcal vaccines, based on the Pneumococcal Vaccines WHO Position Paper (2012) and other latest evidence globally, to introduce comprehensive knowledge of pneumococcal disease, and for the purpose to improve the capacity of the professionals working on pneumococcal disease control and prevention and to provide appropriate evidences of pneumococcal vaccine applications for people who are engaged in public health and immunization vaccination.

Effect of influenza and 23-valent pneumococcal polysaccharide vaccinations on elderly with chronic obstructive pulmonary diseases: a community-based intervention study / 中华流行病学杂志

Objective To explore the effect of influenza and 23 valent pneumococcal polysaccharide pneumococcal vaccinations on symptom-improvement among elderly with chronic obstructive pulmonary diseases (COPD).Methods Data was gathered from 4 communities in 3 National Demonstration Areas set for comprehensive prevention and control of chronic non-communicable diseases in Chongqing city and Ningbo city respectively,from November 2013 to October 2014.The communities were selected by cluster sampling and divided into 4 groups:(1) injected influenza vaccines;(2) injected with pneumococcal vaccines;(3) received both of the two vaccines;(4) the control group that without any intervention measures.All the subjects aged from 60 to 75 were selected to fill in demographic information questionnaire and receive (COPD assessment test,CAT) scores twice,before intervention and 1 year after the vaccination.SAS 9.4 software was used to analyze the change of symptoms and CAT scores before and after the intervention program and comparing the improvement on symptoms among the elderly people under study.Results A total of 1 244 subjects with nearly same baseline conditions after the propensity score matching,were involved in this study.CAT scores appeared as Median=21 (IQR:17-26) at baseline.The CAT scores appeared as Median=18 (IQR:14-24),decreasing in all the 3 vaccinated groups,one year after the intervention program (influenza vaccines,matching t test,t=-6.531,P=0.403;pneumococcal vaccines,Wilcoxon test,H=-9 623,P＜0.001;combined vaccine vaccines,matching t test,t=-10.803,P＜0.001).However,in the control group,no obvious change was observed (Wilcoxon H=1 167,P=0.403).Proportions of impacts at high or very high levels all decreased in the 3 intervention groups,while little change was observed in the control group.Outcomes from the Factorial analysis suggested that influenza vaccination could improve the general conditions and symptoms including cough,chest tightness,dyspnea,physical activities,and stamina.Pneumococcal vaccination appeared more effective on all of symptoms and indicators.Conclusion Pneumococcal and influenza vaccination seemed helpful for elderly people suffering COPD to improve the general health condition.

Effect of influenza and 23-valent pneumococcal polysaccharide vaccinations on elderly with chronic obstructive pulmonary diseases: a community-based intervention study / 中华流行病学杂志

Objective To explore the effect of influenza and 23 valent pneumococcal polysaccharide pneumococcal vaccinations on symptom-improvement among elderly with chronic obstructive pulmonary diseases (COPD).Methods Data was gathered from 4 communities in 3 National Demonstration Areas set for comprehensive prevention and control of chronic non-communicable diseases in Chongqing city and Ningbo city respectively,from November 2013 to October 2014.The communities were selected by cluster sampling and divided into 4 groups:(1) injected influenza vaccines;(2) injected with pneumococcal vaccines;(3) received both of the two vaccines;(4) the control group that without any intervention measures.All the subjects aged from 60 to 75 were selected to fill in demographic information questionnaire and receive (COPD assessment test,CAT) scores twice,before intervention and 1 year after the vaccination.SAS 9.4 software was used to analyze the change of symptoms and CAT scores before and after the intervention program and comparing the improvement on symptoms among the elderly people under study.Results A total of 1 244 subjects with nearly same baseline conditions after the propensity score matching,were involved in this study.CAT scores appeared as Median=21 (IQR:17-26) at baseline.The CAT scores appeared as Median=18 (IQR:14-24),decreasing in all the 3 vaccinated groups,one year after the intervention program (influenza vaccines,matching t test,t=-6.531,P=0.403;pneumococcal vaccines,Wilcoxon test,H=-9 623,P＜0.001;combined vaccine vaccines,matching t test,t=-10.803,P＜0.001).However,in the control group,no obvious change was observed (Wilcoxon H=1 167,P=0.403).Proportions of impacts at high or very high levels all decreased in the 3 intervention groups,while little change was observed in the control group.Outcomes from the Factorial analysis suggested that influenza vaccination could improve the general conditions and symptoms including cough,chest tightness,dyspnea,physical activities,and stamina.Pneumococcal vaccination appeared more effective on all of symptoms and indicators.Conclusion Pneumococcal and influenza vaccination seemed helpful for elderly people suffering COPD to improve the general health condition.

Safety of influenza vaccine and 23-valent pneumococcal polysaccharide vaccine immunized alone or in combination in the elderly / 中华微生物学和免疫学杂志

Objective To evaluate the safety of influenza vaccine and 23-valent pneumococcal polysaccharide vaccine (PPV23) immunized alone or in combination in elderly people and to raise the awareness of vaccine safety among the elderly. Methods From October 2014 to September 2015,454 eld-erly people who were over 60 years old and immunized with influenza vaccine and PPV23 alone or in combi-nation were recruited in this study and divided into five groups. Local and systemic reactions occurred within one month after vaccination were recorded. Results (1) Incidences of adverse reactions among all subjects and people vaccinated with influenza vaccine alone,domestic PPV23 alone,imported PPV23 alone,domes-tic PPV23 combined with influenza vaccine and imported PPV23 combined with influenza vaccine were 10.13%,5.35%,11.63 %,9.52%,17.24% and 12.63%,respectively. Local reaction,injection site pain and mild reaction were the common reactions to vaccination. All reactions occurred within seven days and most of them occurred within 30 minutes to one day after vaccination(82.61%). All subjects recovered within seven days and most of them recovered within one day (84.78%). (2) Compared with the people immunized with domestic or imported PPV23 or influenza vaccine alone,those immunized in combination had higher incidences of reactions to vaccination. Among the three single vaccination groups, domestic PPV23 group had the highest incidence of reactions,followed by imported PPV23 and influenza vaccine groups,but no significant difference was found among them(P>0.05). The incidence of responses to influenza vaccine combined with domestic PPV23 was higher than that to influenza vaccine combined with imported PPV23, but no significant difference was found between them (P>0.05). (3) In each group,women,people aged≥70 years or with chronic diseases had a higher incidence of responses to vaccination than men,people aged 60 to 69 years or without chronic diseases,respectively (P>0.05). Conclusion Immunization with influ-enza vaccine and PPV23 alone or in combination is safe and tolerable in elderly people regardless of gender, age,or whether they are suffering from chronic diseases or not. Both domestic and imported PPV23 have the feature of good safety.

Immunization coverage and safety of the 23-valent pneumococcal polysaccharide vaccine in Guang-zhou from 2010 to 2015 / 中华微生物学和免疫学杂志

Objective To analyze the immunization coverage of 23-valent pneumococcal polysac-charide vaccine(PPV23)in a large population in Guangzhou and to evaluate its safety by analyzing the ad-verse events following immunization(AEFI)reported to the passive surveillance system. Methods Immu-nization data of PPV23 in Guangzhou from 2010 to 2015 were collected from Information Management System of Biological Products and the Information System of Immune Programming of Guangzhou. AEFI reported to the AEFI Information System during 2010 to 2015 was collected for safety evaluation. The collected data were analyzed by using descriptive methodology. Results A total of 621 059 doses of PPV23 were pre-scribed in Guangzhou from 2010 to 2015. Most of the recipients were children younger than 10 years old,ac-counting for 79. 44% . Only 9. 38% of the subjects received PPV23 were older than 60 years. A total of 243 AEFI cases were reported at a rate of 39. 13 cases per 100 000 doses,among which 199 cases(32. 04 / 105 ) showed minor vaccine reactions,25 cases(4. 03 / 105 )occurred adverse events,16 cases(2. 58 / 105 )de-veloped coupled diseases and 3 cases(0. 48 / 105 )were classified as psychogenic reactions. No rare adverse reactions were observed. Conclusion The majority of people immunized with PPV23s in Guangzhou were children,while the immunization coverage among the elderly was relatively low. PPV23 was safe for vaccina-tion as the reported AEFI cases were similar to that of other vaccines.

Study on the Pharmacoeconomics of 23-valent Pneumococcal Polysaccharide Vaccine in Elderly:A System-atic Review / 中国药房

OBJECTIVE:To provide theoretical support for the scientific and reasonable policy-making of 23-valent pneumococ-cal polysaccharide vaccine(PPV-23)in elderly. METHODS:Retrieved from CJFD,Wanfang Database,Elsevier and PubMed,lit-erature about the pharmacoeconomics evaluation of PPV-23 in elder were selected and statistically analyzed in respects of cost stud-ies,effect indexes and research perspectives. RESULTS:Totally 13 literatures were included,involving 900 472 patients,who were older than 60 years old. Study locations were mainly Colombia,the United States,Italy,Belgium and China. Study results showed,each additional quality-adjusted life-year(QALY)cost was between $ 9 239-$ 33 000 in respect of cost;cost-effectiveness ratio was between $ 9 239-$ 45 161/QALY in respect of effect indexes. Most researches showed PPV-23 in elderly older than 65 years old had certain cast-effectiveness. Only a research in Netherlands held the idea that PPV-23 in elderly was not considered cost-effectiveness.CONCLUSIONS:Putting PPV-23 inelderly has certain cost-effecctiveness and most countries has put it into nation-al immunization program. The present researches can't ensure the economy of putting ppv-23 in elderly in china,so it needs more researches with high quality to ensure it.

Overwhelming Pneumococcal Sepsis in a Patient with Splenic Hypoplasia / General Medicine

A 58-year-old female was admitted due to severe sepsis and multi-organ failure with a fulminant purpuric rash. Meropenem, vancomycin and levofloxacin were administered, although no focus of infection was detected. However, computed tomography revealed a profoundly hypoplastic spleen, and a blood smear detected Howell-Jolly bodies. Blood cultures grew <i>Streptococcus pneumoniae</i> (serotype 22F) three hours after admission. The patient was finally diagnosed as overwhelming pneumococcal sepsis with hyposplenism precipitated by splenic hypoplasia. Clinicians should pay attention to the splenic size and Howell-Jolly bodies in cases of sepsis of unknown origin.