23-valent Vaccine Research Articles

HPV genotyping of cervical histologic specimens of 61, 422 patients from the largest women hospital in China.

We investigated HPV genotypes in a large cohort of patients with definitive cervical histologic diagnosis. HPV testing was performed by real-time PCR assay, including 18 high-risk HPV (hrHPV) and 3 low-risk HPV (lrHPV). Totally 61,422 patients with documented HPV genotyping results within 6 months before cervical histologic diagnoses were included. HrHPV positive rate was 55.1% among all tested cases with the highest in adenosquamous carcinoma (94.1%), followed by squamous cell carcinoma (SCC) (93.7%), cervical intraepithelial neoplasia 2/3 (CIN2/3) (92.8%). HrHPV positive rates were significantly higher in high-grade squamous lesions than in those in glandular lesions. HPV16 was the most common genotype followed by HPV52 and HPV58 in CIN2/3. The most frequent hrHPV genotype in adenocarcinoma in situ (AIS) was HPV18, followed by HPV16, HPV45 and HPV52. In SCC cases, HPV16 was the most common type followed by HPV58, HPV52, HPV18 and HPV33. However, HPV18 showed significantly higher prevalence in adenocarcinoma and adenosquamous carcinoma than in that in SCC. Theoretically, the protective rates of 2/4-valent and 9-valent vaccine were 69.1% and 85.8% for cervical cancers. The prevalence of HPV genotypes in Chinese population was different from that in Western population. Some hrHPV types were identified in cervical precancerous lesions and cancers, which are not included in current HPV vaccines. These data provide baseline knowledge for future HPV vaccine development.

Development and Validation of Two Optimized Multiplexed Serologic Assays for the 9-Valent Human Papillomavirus Vaccine Types.

Two multiplex immunoassays are routinely used to assess antibody responses in clinical trials of the 9-valent human papillomavirus (9vHPV) vaccine. The HPV6/11/16/18/31/33/45/52/58 competitive Luminex immunoassay (HPV-9 cLIA) and HPV6/11/16/18/31/33/45/52/58 total immunoglobulin G Luminex immunoassay are used for measurements of immunogenicity. Following their initial validation in 2010, both assays were redeveloped, and several parameters were optimized, including the coating concentration of virus-like particles, type of Luminex microspheres, serum sample and reference standard diluent, reference standard starting dilution and titration series, and vendor and concentration of the phycoerythrin-labeled antibodies. Validation studies evaluated the assay performance parameters, including the intra-assay precision (repeatability), intermediate precision, linearity, relative accuracy, and limits of quantitation. In addition, since maintaining a link to the original assays that were used in trials supporting vaccine licensure is critical, the assays were formally bridged to the previous assay versions by using individual patient sera from a 9vHPV vaccine clinical trial (n = 150 day 1 [prevaccination] samples; n = 100 month 7 [1 month post-last vaccine dose] and n = 100 month 36 [30 months post-last vaccine dose; antibody persistence] samples). The results of the validation studies indicate that both optimized assays are accurate, specific, and precise over their respective quantifiable ranges. There was a strong linear association between the new and previous versions of both assays. Assay serostatus cutoffs for the redeveloped assays were established based on the bridging studies and, for the HPV-9 cLIA, further refined, based on additional data from HPV vaccine clinical studies so as to align the seropositivity rates between assay versions. IMPORTANCE Assay modernization is a key aspect of vaccine life cycle management. Thus, new, reoptimized versions of two 9vHPV immunoassays have been developed and validated for use in ongoing and future HPV vaccine clinical trials. These assays are suitable for use in high-throughput testing for HPV antibodies in serum samples. Bridging to previous versions of the assays allows for the continuous monitoring of immune responses across assay versions, including in immunogenicity studies that involve new populations as well as long-term follow-up studies.

Safety and immunogenicity of an Escherichia coli-produced 9-valent human papillomavirus L1 virus-like particle vaccine (types 6/11/16/18/31/33/45/52/58) in healthy adults: an open-label, dose-escalation phase 1 clinical trial

A safe and highly efficacious Escherichia coli (E.coli)-produced HPV 16/18 bivalent vaccine has been prequalified by the World Health Organization. Here, we conducted a single-center, open-label, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine. Twenty-four eligible volunteers aged 18-45 years were enrolled in January 2019 in Dongtai, China and received 0.5mL (135μg) or 1.0mL (270μg) of the candidate vaccine with a 0/1/6-month dose-escalation schedule. Local and systemic adverse events (AEs) occurring within 30 days after each vaccination and serious adverse events (SAEs) occurring within 7 months were recorded. Blood samples from each participant were collected before and 2 days after the first and third vaccinations to determine changes in laboratory parameters. Serum IgG and neutralizing antibody (nAb) levels against each HPV type at month 7 were analyzed (ClinicalTrials.gov: NCT03813940). The incidences of total AEs in the 135μg and 270μg groups were 66.7% and 83.3%, respectively. All AEs were mild or moderate, and no SAEs were reported. No clinically significant changes were found in paired blood indices before or after any of the vaccinations. All the participants in the per-protocol set except for two who failed to seroconvert for HPV 11 or 58 in the 135μg group seroconverted at month 7 for both IgG and nAbs. The candidate E.coli-produced 9vHPV vaccine has been preliminarily proven to be well tolerated and immunogenic, which encourages further studies in large cohorts with a wider age range. This study was supported by the National Natural Science Foundation of China, Fujian Provincial Natural Science Foundation, Fujian Province Health and Education Joint Research Program, Xiamen Science and Technology Plan Project, Fundamental Research Funds for the Central Universities, CAMS Innovation Fund for Medical Sciences of China, and Xiamen Innovax Biotechnology Co., Ltd.

Incidence and clinical and microbiological features of invasive and probable invasive streptococcal group A infections in children and adults in the Brussels-Capital Region, 2005–2020

Assess the incidence, risk factors, clinical and microbiological features, and outcome of both probable invasive and invasive group A Streptococcus (GAS) infections in children and adults in the BrusselsCapital Region between 2005 and 2020. A retrospective, multicentric study was performed in three university hospitals in Brussels. Patients were identified through the centralized laboratory information system. Epidemiological and clinical data were collected from patients' hospital records. A total of 467 cases were identified. Incidence has increased from 2.1 to 10.9/100,000 inhabitants between 2009 and 2019 in non-homeless adults while it was above 100/100,000 on homeless in years with available denominators. Most of GAS were isolated from blood (43.6%), and the most common clinical presentation was skin and soft tissue infections (42.8%). A third of all the patients needed surgery, a quarter was admitted to the intensive care unit, and 10% of the adult patients died. Wounds and chickenpox disease were the main risk factors for children. Tobacco, alcohol abuse, wounds or chronic skin lesion, being homeless, and diabetes were identified as major predisposing factors for adults. The most common emm clusters were D4, E4, and AC3; 64% of the isolates were theoretically covered by the 30-valent M-protein vaccine. The burden of invasive and probable invasive GAS infections is on the rise in the studied adult population. We identified potential interventions that could contribute to decrease this burden: appropriate care of wounds, specifically among homeless and patients with risk factors such as diabetes and systematic chickenpox vaccination for children.

Immunogenicity and Safety of One-Dose Human Papillomavirus Vaccine Compared With Two or Three Doses in Tanzanian Girls (DoRIS): An Open-Label, Randomised, Non-inferiority Trial

ABSTRACT The global burden of cervical cancer remains very high, with more than 340,000 potentially preventable deaths annually and disproportionally affects low-income and middle-income countries. Countries that have adopted HPV vaccination administer a multidose schedule with 2 doses offered to girls younger than 15 years, and 3 offered to girls 15 years and older or immunocompromised individuals. Unfortunately, several barriers to full immunization remain, and only 15% of girls in the target age group worldwide are estimated to be fully vaccinated. A single-dose vaccine would remove many barriers and be significantly cheaper; however, evidence is needed on the immunogenicity and efficacy. This randomized phase 3 clinical trial (DoRIS) aimed to examine immune responses after a single dose of HPV vaccine in the target age group for HPV vaccination in Tanzania. Girls aged 9–14 years who have not been vaccinated for HPV and did not have any history of cervical lesions, treatment for positive cervical cancer screening, or immunocompromised status were invited from Government schools to participate. Participants were randomized to 1 of 6 arms comprising 3 different dose schedules of 2 different HPV vaccines (3 doses over 6 months, 2 doses given 6 months apart, or a single dose for either the 2-valent vaccine or the 9-valent vaccine). Blood samples were collected for immunological assays at 1, 7, 12, and 24 months after vaccination. The primary study outcome was noninferiority of HPV 16 and HPV 18 specific seropositivity after a single dose compared with 2 or 3 doses of the same vaccine 24 months after vaccination. Primary analyses were undertaken in the per-protocol population, including those who received the allocated doses of HPV vaccine in the protocol-defined window. A sensitivity analysis included all participants who received at least 1 dose of HPV vaccine. A total of 930 girls were enrolled and randomized with 155 participants per group. At 24 months, 856 (93%) girls were included in the per-protocol analysis of anti-HPV 16 antibody responses, and 831 (91%) in the per-protocol analysis of anti-HPV 18. All but 2 participants were seropositive for HPV 16 IgG at 24 months (1 participant in each of the 1-dose arms was not), and all but 6 participants were HPV 18 seropositive at 24 months (2 in the 1-dose 2-valent group, 3 in the 1-dose 9-valent group, and 1 in the 3-dose 9-valent group). Noninferiority of HPV 16 seroconversion was met at 24 months for 1 dose compared with 2 doses or 3 doses for both vaccines; however, noninferiority for HPV 18 seroconversion was not met despite 98% of girls in the 1-dose arms of both vaccines testing positive for anti-HPV 18. There was no difference in serious adverse events among study groups or any serious adverse events related to the vaccine. The results of this study demonstrate that, in healthy Tanzanian girls, a single dose of the 2-valent or 9-valent HPV vaccines was well tolerated and resulted in high seropositivity and induced stable vaccine responses that persisted to 24 months.

Vaccine coverage for recommended vaccines among splenectomised patients in Apulia, South Italy: a retrospective cohort study

ObjectiveSplenectomised/asplenic patients have a 10–50 fold higher risk than the general population of developing overwhelming postsplenectomy infection. To control this risk, these patients have to receive a specific immunisation schedule,...

A cost-effectiveness analysis of pneumococcal conjugate vaccines in infants and herd protection in older adults in Colombia

ABSTRACTBackgroundPneumococcal diseases have a clinical and economic impact on the population. Until this year, a 10-valent pneumococcal vaccine (PCV10) used to be applied in Colombia, which does not contain serotypes 19A, 3, and 6A, the most prevalent in the country. Therefore, we aimed to assess the cost-effectiveness of the shift to the 13-valent pneumococcal vaccine (PCV13).Research design and methodsA decision model was used for newborns in Colombia between 2022–2025 and adults over 65 years. The time horizon was life expectancy. Outcomes are Invasive Pneumococcal Diseases (IPD), Community-Acquired Pneumonia (CAP), Acute Otitis Media (AOM), their sequelae, Life Gained Years (LYGs), and herd effect in older adults.ResultsPCV10 covers 4.27% of serotypes in the country, while PCV13 covers 64.4%. PCV13 would avoid in children 796 cases of IPD, 19,365 of CAP, 1,399 deaths, and generate 44,204 additional LYGs, as well as 9,101 cases of AOM, 13 cases of neuromotor disability and 428 cochlear implants versus PCV10. In older adults, PCV13 would avoid 993 cases of IPD and 17,245 of CAP, versus PCV10. PCV13 saves $51.4 million. The decision model shows robustness in the sensitivity analysis.ConclusionPCV13 is a cost-saving strategy versus PCV10 to avoid pneumococcal diseases.

Prevalence of HPV and Assessing Type-Specific HPV Testing in Cervical High-Grade Squamous Intraepithelial Lesions in Poland.

The prevalence and distribution of oncogenic human papillomavirus (HPV) genotypes in women who underwent screening for cervical cancer in the Wielkopolska region, Poland, were assessed, and the correlation of genotypes with the histological results was evaluated. Cervical samples were collected from 2969 women for cervical cancer screening. Participants were screened by liquid-based cytology and HPV genotyping (n = 1654) and referred to colposcopy and punch biopsy (n = 616) if recommended. HPV genotypes 16, 31, 52, 66, 53, and 51 are the most frequent types in the studied population. Genotypes 16 and 31 account for nearly one-fifth of the infections of diagnosed HPV infections. HPV 16, 31, and 52 are found in nearly 80% of premalignant HSIL lesions (CIN 2 and CIN 3). That leads to the conclusion that vaccination programs should cover as many types of HPV as possible and shows the urgent need to vaccinate the Polish population with a 9-valent vaccine.

Nasopharyngeal colonization by Streptococcus pneumoniae in children and adults before the introduction of the 10-valent conjugate vaccine, Paraguay.

Streptococcus pneumoniae is a cause of invasive diseases such as pneumonia, meningitis, and other serious infections among children and adults in Paraguay. This study was conducted to establish S. pneumoniae baseline prevalence, serotype distribution, and antibiotic resistance patterns in healthy children aged 2 to 59 months and adults ≥60 years of age prior to the introduction of PCV10 in the national childhood immunization program in Paraguay. Between April and July 2012, a total of 1444 nasopharyngeal swabs were collected, 718 from children aged 2 to 59 months and 726 from adults ≥60 years of age. The pneumococcal isolation, serotyping, and antibiotic susceptibility testing were performed using standard tests. Pneumococcal colonization prevalence was 34.1% (245/718) in children and 3.3% (24/726) in adults. The most frequent pneumococcal vaccine-types (VT) detected in the children were 6B (42/245), 19F (32/245), 14 (17/245), and 23F (20/245). Carriage prevalence with PCV10 serotypes was 50.6% (124/245) and PCV13 was 59.5% (146/245). Among colonized adults, prevalence of PCV10 and PCV13 serotypes were 29.1% (7/24) and 41.6% (10/24), respectively. Colonized children were more likely to share a bedroom, have a history of respiratory infection or pneumococcal infection compared to non-colonized children. no associations were found in adults. However, no significant associations were found in children and neither in adults. Vaccine-type pneumococcal colonization was highly prevalent in children and rare in adults in Paraguay prior to vaccine introduction, supporting the introduction of PCV10 in the country in 2012. These data will be useful to evaluate the impact of PCV introduction in the country.

Recommended Adult Immunization Schedule, United States, 2023.

Recommended Adult Immunization Schedule, United States, 2023.

The safety of pneumococcal vaccines at the time of sequential schedule: data from surveillance of adverse events following 13-valent conjugated pneumococcal and 23-valent polysaccharidic pneumococcal vaccines in newborns and the elderly, in Puglia (Italy), 2013-2020.

Nowadays, two types of anti-pneumococcal vaccine are available: pneumococcal 13-valent conjugate vaccine (PCV13), first licensed in the United States (US) in 2013, and pneumococcal 23-valent polysaccaridic vaccine (PPSV23), first licensed in the US in 1999. These vaccines are recommended in Italy for the immunization of newborns and of the elderly, using a combined sequential schedule for the latter. This report aims to describe the PCV13- and PPSV23-related AEFIs notified in Puglia in 2013-2020, in order to design these products' safety profile in a real-life scenario, three years after the official recommendation about the sequential schedule for people over 60 years of age. This is a retrospective observational study. Data were gathered from the list of AEFIs notified following PCV13 and PPSV23 administration in Puglia in 2013-2020. The number of administered vaccine doses was obtained from the regional immunization database. AEFIs were classified according to WHO's algorithm, and causality assessment was carried out in case of serious AEFIs. From January 2013 to December 2020, 764,183 doses of PCV13 and 40,382 doses of PPSV23 were administered in Puglia. In the same period, 71 PCV13 AEFIs (Reporting Rate: 9.29 x100,000 doses) and 5 PPSV23 AEFIs (Reporting Rate: 12.4 x100,000 doses) were reported. The overall male/female ratio in AEFIs was 0.85. The majority of AEFIs occurred in subjects aged less than 2 (64/76, 84.2%), while 10 out of 76 (13.2%) occurred in patients aged 60 or older. 22 AEFIs were classified as serious and for 12 (54.5%) causality assessment showed a consistent relationship with immunization. The most commonly reported symptoms were fever (Reporting Rate: 4.72 x100,000 doses) and neurological symptoms (Reporting Rate: 3.23 x100,000 doses). Only one death was notified, classified as non-vaccine-related. The benefit of pneumococcal vaccination appears to be greater than the risk of AEFIs for both PCV13 and PPSV23. In fact, AEFIs occur in less than 0.1‰ of patients and the majority of AEFIs are mild and self-limiting.

Exploring the Role of GMMA Components in the Immunogenicity of a 4-Valent Vaccine against Shigella.

Shigellosis is the leading cause of diarrheal disease, especially in children of low- and middle-income countries, and is often associated with anti-microbial resistance. Currently, there are no licensed vaccines widely available against Shigella, but several candidates based on the O-antigen (OAg) portion of lipopolysaccharides are in development. We have proposed Generalized Modules for Membrane Antigens (GMMA) as an innovative delivery system for OAg, and a quadrivalent vaccine candidate containing GMMA from S. sonnei and three prevalent S. flexneri serotypes (1b, 2a and 3a) is moving to a phase II clinical trial, with the aim to elicit broad protection against Shigella. GMMA are able to induce anti-OAg-specific functional IgG responses in animal models and healthy adults. We have previously demonstrated that antibodies against protein antigens are also generated upon immunization with S. sonnei GMMA. In this work, we show that a quadrivalent Shigella GMMA-based vaccine is able to promote a humoral response against OAg and proteins of all GMMA types contained in the investigational vaccine. Proteins contained in GMMA provide T cell help as GMMA elicit a stronger anti-OAg IgG response in wild type than in T cell-deficient mice. Additionally, we observed that only the trigger of Toll-like Receptor (TLR) 4 and not of TLR2 contributed to GMMA immunogenicity. In conclusion, when tested in mice, GMMA of a quadrivalent Shigella vaccine candidate combine both adjuvant and carrier activities which allow an increase in the low immunogenic properties of carbohydrate antigens.

Human papilloma virus infection and its associated risk for cervical lesions: a cross-sectional study in Putuo area of Shanghai, China

ObjectiveTo investigate the human papilloma virus (HPV) infection status, main subtypes and age distribution characteristics of women in the Putuo area of Shanghai.MethodsA total of 13,936 subjects were enrolled in this study. These subjects were 15–89 years old, with a mean age of 41.68. Real-time fluorescence quantitative polymerase chain reaction technology was used to detect 21 types of HPV.ResultsA total of 2,500 subjects with HPV infections were detected in 13,936 cervical exfoliated cell specimens (total infection rate 17.9%). There were 15 people aged below 20,486 people aged 21-30,876 people aged 31-40,484 people aged 41–50, 338 people aged 51–60, and 301 people aged > 60. In total, 1,893 (75.7%) subjects had a single type of HPV infection, 424 (16.9%) had a double infection, and 183 had triple or more infections (7.4%). The top 6 subtypes of HPV infection in the Shanghai Putuo District were HPV 52 (3.81%), HPV 58 (2.46%), HPV 16 (2.43%), HPV 53 (2.30%), HPV 81 (1.74%) and HPV 39 (1.5%). The number of high-risk HPV infections was 1,978, and the total infection rate was 14.19%. The number of intermediate-risk HPV infections was 578, and the total infection rate was 4.15%. The number of low-risk HPV infections was 338, and the total infection rate was 2.43%.ConclusionThe top 3 populations with HPV infection rates in the Putuo District, Shanghai, were ≤ 20 years old, older than 60, and 21–30 years old. The infection rate of HPV in cervical outpatient clinics was significantly higher than that of other departments. The 9-valent vaccine is recommended for HPV vaccination in this area.

Human Papillomavirus Vaccinations: Provider Education to Enhance Vaccine Uptake.

Human papillomavirus (HPV) is the number one sexually transmitted infection (STI) worldwide. The Centers for Disease Control and Prevention (CDC) approximated that 92% of HPV-related cancers might be prevented by receiving the HPV 9-valent vaccine (Gardasil 9). The 2-dose HPV vaccine for children ages 11 to 12 years provides almost 100% protection against strains affiliated with cervical, vaginal, and vulvar cancers. Provider education is essential to decrease clinical knowledge deficits and increase vaccination uptake. Evidence-based provider recommendations expressed to eligible individuals improves vaccination rates. Evidence-based approaches for vaccine-hesitant parents involve using the presumptive announcement approach, asking for and addressing main concerns, and trying again if the parent initially declines. Seventy percent of parents who initially decide not to get their child vaccinated later agree to the vaccine or schedule a follow-up appointment. The CDC guidelines for HPV vaccinations, including the catch-up and adult guidelines, are reviewed. A clinical vignette with case scenarios and a Q&A quiz are included.

The Efficacy of Human Papillomavirus Vaccination as an Adjuvant Therapy in Recurrent Respiratory Papillomatosis.

To characterize the efficacy of human papillomavirus (HPV) vaccination as an adjuvant therapy in recurrent respiratory papillomatosis (RRP). PubMed, Embase, Cochrane, Google Scholar, ClinicalTrials.gov, and Web of Science databases were queried for articles published before April 2021. All retrieved studies (n=870) were independently analyzed by two reviewers according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement using predefined inclusion and exclusion criteria.13 studies met inclusion criteria. A random-effects meta-analysis was performed to study intersurgical interval (ISI) and number of surgical procedures per year before and after vaccination. The systematic review included 13 studies, comprising 243 patients. All studies utilized the Gardasil® quadrivalent vaccine, and one study (Yiu et al. 2019) utilized both the quadrivalent and Gardasil® 9-valent vaccines. Our meta-analysis included 62 patients with ISI data across 4 studies, and 111 patients with data on the number of surgical procedures per month across 7 studies. The mean number of surgical procedures decreased by 4.43 per year after vaccination (95% CI, -7.48 to -1.37). Mean ISI increased after vaccination, with a mean difference of 15.73 months (95% CI, 1.46-29.99). Two studies reported on HPV sero-conversion, with HPV seropositivity of 100% prior to vaccination and 25.93% after vaccination. The addition of HPV vaccination was associated with an increase in time between surgeries and reduction in the number of surgical procedures required. HPV vaccination may be a beneficial adjuvant treatment for RRP. NA Laryngoscope, 133:2046-2054, 2023.

Risk of Premature Ovarian Insufficiency after Human Papilloma Virus Vaccination: A PRISMA Systematic Review and Meta-Analysis of Current Evidence

(1) Background: Premature ovarian insufficiency (POI) has been linked to human papilloma virus (HPV) vaccination in small case-reports. The aim of this meta-analysis was to evaluate the risk of POI after HPV vaccination. (2) Methods: Electronic searches in MEDLINE Scopus, LILACS, ClinicalTrials.gov, EMBASE, PROSPERO, Cochrane CENTRAL and other registries were searched from inception to September 2022. Inclusion criteria were cohort studies of female children or adolescents vaccinated with quadrivalent (4vHPV), bivalent (2vHPV) or 9-valent (9vHPV) vaccine and compared to unvaccinated, other HPV vaccine, or vaccinated with other childhood vaccine girls. Primary outcome was risk of POI after vaccination. (3) Results: Four studies, including 1,253,758 patients, were included. Overall, there was no significant risk for POI between 4vHPV and controls (unvaccinated or other vaccines) (RR 0.47 (95% CI 0.14 to 1.59) I2 = 75%), or unvaccinated only controls (RR 0.75 (95% CI 0.22 to 2.49) I2 = 26%). One study reported a significant reduction of POI risk for 4vHPV relative to the other childhood vaccinations (RR 0.03 (95% CI 0.00 to 0.21)); meanwhile, one study showed no increased risk with 4vHPV relative to 2vHPV and 9vHPV (RR 0.93 (95% CI 0.33 to 2.64)). (4) Conclusions: 4vHPV vaccination does not seem to increase risk of POI relative to unvaccinated people or other childhood vaccines. No difference was seen with 4vHPV vaccine relative to 2vHPV and 9vHPV. Moreover, the risk of POI after HPV vaccination is relatable to worldwide incidence, giving reassurance about safety.

Cost-effectiveness of pneumococcal vaccines among adults aged 65years and older in China: A comparative study.

We aimed to assess the cost-effectiveness and health benefits of 23-valent pneumococcal polysaccharide vaccine (PPSV23), 13-valent pneumococcal conjunctive vaccine (PCV13), and PCV13-PPSV23 sequential vaccination strategies in preventing pneumonia and other pneumococcal diseases among the senior citizens (≥ 65years) in China. The cost-effectiveness of pneumococcal vaccines compared to no vaccination was estimated using a decision-tree Markov model from a societal perspective. Parameters including epidemiological data, vaccine efficacy and cost data were obtained from previous studies. Cases and deaths averted, quality-adjusted life years (QALYs) gained, and incremental cost-effectiveness ratios (ICERs) were presented as outcomes. Sensitivity analyses were performed to explore the uncertainty in the model. In the base-case analysis, compared with no pneumococcal vaccination, the ICERs of PPSV23, PCV13 and PCV13-PPSV23 are US$10,776.7/QALY, $9,193.2/QALY, and $15,080.0/QALY, respectively. PCV13 is the most cost-effective strategy and the only cost-effective strategy based on a threshold of the one-time national GDP per capita, whereas PPSV23 vaccine strategy is provided with the lowest cost, and PCV13-PPSV23 demonstrates the greatest impact on pneumococcal disease burden. Sensitivity analyses reveal that the results are greatly influenced by serotype coverage, vaccine efficacy, CAP incidence and vaccine prices. The PCV13 vaccination for Chinese seniors is more cost-effective than PPSV23 vaccination and PCV13-PPSV23 sequential vaccination.

Чaстота носительства S. pneumoniae у организованных детей г. Ханты-Мансийска

Aim: to assess the landscape of pneumococcus serotypes among children organized in kindergarten groups in Khanty-Mansiysk city. Patients and Methods: the study included 510 children (2-6 years old) attending kindergartens in Khanty-Mansiysk city. The children were divided into 2 groups: vaccinated (n=50) and non-vaccinated against pneumococcal infection (n=460). The data on vaccination status were received from the prophylactic immunization records (Form 063/u) and child's medical records (Form 112/u). In addition, the following data were analysed: age, gender, gestation age at birth, attitudes of child's legal representatives towards vaccinations, and the presence of chronic health problems. Pneumococcal polysaccharide conjugate adsorbed 13-valent vaccine (PCV-13) was used for the prevention of pneumococcal disease. Nasopharyngeal swabs were collected from children as a source of biological material. The pneumococcus was detected using a culture-based method and PCR assay. Results: the average age of organized children examined in Khanty-Mansiysk for Streptococcus pneumoniae (S. pneumoniae, pneumococcus) was 54.31 [53.46–55.16] months. In 56% of the examined children, pneumococcal DNA was found in nasopharyngeal swabs by polymerase chain reaction assay. The identified serotypes in 71.1% of cases were the same as in the PCV13 vaccine formulation. The most common serotypes detected were 4 (27%), 19 F (13.3%), 23 F (3.6%) and serogroup 6 (11.6%). In children immunized against S. рneumoniae, the pneumococcal strain DNAs, same as the vaccine strain DNAs, were found in 53.7% of cases, while in non-immunized children — in 73% of cases (OR 0.54, 95% CI 0.29–0.97). Conclusion: the increasing prevalence of S. рneumoniae carriage in children as they get older and attend organized children's groups for a longer time, along with the predominance within the population of the same pneumococcus strains as those in the vaccine formulation, dictate the need for timely immunization against pneumococcal infection in compliance with the National Vaccination Schedule (vaccination at 2 and 4.5 months of age, revaccination at 15 months of age). KEYWORDS: children, pneumococcal infection, S. pneumoniae, vaccination, pneumococcal conjugate vaccine, children in organized groups, carriage. FOR CITATION: Girina A.A., Petrovsky F.I., Petrovskaya Yu.A., Zaplatnikov A.L. Prevalence of S. pneumoniae carriage among children organized in kindergarten groups in Khanty-Mansiysk city. Russian Journal of Woman and Child Health. 2023;6(2):164–168 (in Russ.). DOI: 10.32364/2618-8430-2023-6-2-164-168.

Preclinical evaluation of an investigational 21-valent pneumococcal conjugate vaccine, V116, in adult-rhesus monkey, rabbit, and mouse models.

Despite the widespread effectiveness of pneumococcal conjugate vaccines on the overall incidence of invasive pneumococcal disease, the global epidemiological landscape continues to be transformed by residual disease from non-vaccine serotypes, thus highlighting the need for vaccines with expanded disease coverage. To address these needs, we have developed V116,an investigational 21-valent non-adjuvanted pneumococcal conjugate vaccine (PCV),containingpneumococcal polysaccharides (PnPs) 3, 6A, 7F, 8, 9N, 10A, 11A,12F, 15A, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B, anda de-O-acetylated 15B(deOAc15B) individually conjugated to the nontoxic diphtheria toxoid CRM197 carrier protein. Preclinical studies evaluated the immunogenicity of V116 inadult monkeys, rabbits, and mice. Following one dose, V116 was found to be immunogenic in preclinical animal species and induced functional antibodies for all serotypes included in the vaccine, in addition to cross-reactive functional antibodies to serotypes 6C and 15B. In these preclinical animal studies, the increased valency of V116 did not result in serotype-specific antibody suppression when compared to lower valent vaccines V114 or PCV13. In addition, when compared with naïve controls, splenocytes from V116 to immunized animals demonstrated significant induction of CRM197-specific T cells in both IFN-γ and IL-4 ELISPOT assays, as well as Th1 and Th2 cytokine induction through in vitro stimulation assays, thus suggesting the ability of V116 to engage T cell dependent immune response pathways to aid in development of memory B cells. V116 also demonstrated significant protection in mice from intratracheal challenge with serotype 24F, a novel serotype not contained in any currently licensed vaccine.

Extended surveillance to assess safety of 9-valent human papillomavirus vaccine

ABSTRACT The safety of 9-valent HPV vaccine (9vHPV) has been established with regard to common and uncommon adverse events. However, investigation of rare and severe adverse events requires extended study periods to capture rare outcomes. This observational cohort study investigated the occurrence of three rare and serious adverse events following 9-valent human papillomavirus (9vHPV) vaccination compared to other vaccinations, in US individuals 9–26 years old, using electronic health record data from the Vaccine Safety Datalink (VSD). We searched for occurrences of Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and stroke following 9vHPV vaccination from October 4, 2015, through January 2, 2021. We compared the risks of GBS, CIDP, and stroke following 9vHPV vaccination to risks of those outcomes following comparator vaccines commonly given to this age group (Td, Tdap, MenACWY, hepatitis A, and varicella vaccines) from January 1, 2007, through January 2, 2021. We observed 1.2 cases of stroke, 0.3 cases of GBS, and 0.1 cases of CIDP per 100,000 doses of 9vHPV vaccine. After observing more than 1.8 million doses of 9vHPV, we identified no statistically significant increase in risks associated with 9vHPV vaccination for any of these adverse events, either combined or stratified by age (9–17 years of age vs. 18–26 years of age) and sex (males vs. females). Our findings provide additional evidence supporting 9vHPV vaccine safety, over longer time frames and for more serious and rare adverse events.