A Randomized, Double-blinded, Multicenter Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Adults

Start Date04 Oct 2021

Sponsor / Collaborator-

RBR-7ymz2q

/ Active, not recruitingPhase 4IIT

Strategies to optimize the access of adults with clinical indications to the 23-valent Pneumococcal Polysaccharide Vaccine within the Brazilian National Public Health System. - SOAP-23: Strategies to Optimize Access to 23-valent Pneumococcal polysaccharide vaccine among adults

Start Date01 Feb 2018

Sponsor / Collaborator

Universidade Estadual Paulista Júlio De Mesquita Filho Unesp

ChiCTR2000030009

/ CompletedPhase 3

A Randomized, Blinded, Parallel Controlled, Phase III Clinical Trial for Evaluation of Immunogenicity and Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Healthy Volunteers Aged 2 Years and Above

Start Date12 Jan 2018

Sponsor / Collaborator

Guangxi Center For Disease Control & Prevention

100 Clinical Results associated with Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

100 Translational Medicine associated with Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

100 Patents (Medical) associated with Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

571

Literatures (Medical) associated with Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

12 Jan 2025·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Chinese expert consensus on the diagnosis and treatment of pneumonia in the elderly (2024 Edition)].

Article

China is experiencing a demographic shift as its population ages. The elderly population becomes increasingly susceptible to pneumonia. Pneumonia in the elderly is characterized by its insidious onset, rapid progression, multiple comorbidities, poor prognosis, and high morbidity and mortality. Physicians need to pay attention to developing more comprehensive diagnostic evaluations and treatment strategies, and ensuring personalized care to the greatest extent. In order to improve the prevention and management of pneumonia in elderly, this consensus incorporates the latest guidelines and consensus from both domestic and international sources. The latest progress in this research field is also included. The document addresses 17 clinical issues in a question-and-answer format and provides 13 recommendations on the etiology, pathogenesis, clinical diagnosis, treatment, and prevention of pneumonia in older adults. It provides reference for the prevention and treatment of pneumonia in elderly, improving their quality of life, reducing hospitalization and mortality, and promoting healthy aging. The specific recommendations are as follows.Recommendation 1:The main risk factors for pneumonia in the elderly include age (Recommended Level ⅠA), age-related systemic factors (such as poor physical condition, underlying diseases, and concomitant medications), and specific factors (specifically dysphagia and aspiration). The risk increases progressively with age (Recommended Level Ⅱ-1A).Recommendation 2:Pneumonia in elderly individuals often presents with an insidious onset and atypical respiratory symptoms, especially in super-elderly patients. Initially, symptoms may include fatigue, loss of appetite, and disturbance of consciousness. Moreover, elderly patients often have underlying conditions such as pulmonary, cardiovascular, and neurological disorders, which can lead to rapid deterioration, multiple complications and sequelae. Pneumonia-related laboratory parameters in the elderly lack typical characteristic changes (Recommended Level ⅢA). The high proportion of comorbidities significantly increases the risk of pneumonia, especially pneumonia caused by drug-resistant bacteria, and the likelihood of a worse prognosis in elderly patients (Recommended Level Ⅱ-2A). Neurological or psychiatric disorders and therapeutic drugs such as antipsychotic drugs increase the risk of pneumonia including aspiration pneumonia, necrotizing pneumonia, lung abscess, hypostatic pneumonia and atelectasis in elderly patients (Recommended Level Ⅱ-2B).Recommendation 3:For elderly patients with suspected pneumonia, chest CT should be performed as early as possible in cases of long-term bed-ridden patients, aspiration pneumonia, or viral pneumonia (Recommended Level ⅢA). If conventional tests fails to identify the pathogen and empirical treatment proves to be ineffective, or if special pathogen infection such as viruses, severe or complex infection, or immunosuppression is suspected, it is advised to use invasive procedures to obtain bronchoalveolar lavage fluid (BALF), pleural effusion, or lung biopsy, and to conduct molecular biology testing (PCR, mNGS, tNGS, etc.) concurrently with conventional pathogen tests (Recommended Level ⅢA).Recommendation 4:The pharmacokinetics (PK) changes of antimicrobial drugs in elderly patients and necessity of dosage reduction should be evaluated according to the unique physiological characteristics of the elderly, such as declining body function, the presence of multiple diseases, and potential medication interactions. It is recommended to combine the PK/PD characteristics of antimicrobial drugs and therapeutic drug monitoring (TDM) methods to guide the individualized and precise prescription for elderly patients with pneumonia. This approach aims to ensure efficacy, minimizing the risk of bacterial resistance, and reduce the incidence of adverse reactions (Recommended Level Ⅱ-2B).Recommendation 5:Timing of treatment: Empiric antimicrobial therapy should be initiated as soon as the diagnosis is made. Except for outpatient clinic visitors with mild symptoms, properly collected respiratory secretions and blood samples should be sent without delay for pathogenic microorganisms testing. During the influenza season, timely empiric antiviral therapy should be initiated without positive result (Recommended Level Ⅱ-1A).Recommendation 6:Coverage of possible pathogens: Due to the increased detection rate of various pathogens such as gram-negative bacteria, anaerobic bacteria, fungi, etc., the initial treatment should cover the possible pathogens. Individualized treatment should be started according to the estimation of drug resistance risk, the of PK/PD principle, and potential drug side effects (Recommended Level Ⅱ-1A).Recommendation 7:Appropriate treatments for promoting sputum drainage and airway clearance in elderly pneumonia patients should be chosen after a comprehensive evaluation of the patient's condition. It is crucial to assess the patient's coughing efficacy to avoid asphyxia (Recommended Level ⅢA).Recommendation 8:We recommend cautious use of glucocorticoids in elderly pneumonia patients. When it is indeed necessary to use glucocorticoids in severe pneumonia cases accompanied by septic shock and hemodynamic instability, it's crucial to tailor drug regimens carefully, monitor closely for adverse reactions, and avoid excessive or prolonged glucocorticoid use (Recommended Level ⅢB).Recommendation 9:Assessing the swallowing abilities of elderly patients is important, and individuals with dysphagia should undergo swallowing rehabilitation. These measures can help reduce the risk of aspiration pneumonia, such as adopting a semi-recumbent posture, thickened fluids and soft foods, proper dental care, tube feeding, and discontinuing medications that increase the risk of aspiration pneumonia in older patients (Recommended Level ⅡA).Recommendation 10:We recommend that elderly individuals get an annual influenza virus vaccine (Recommended Level ⅠA), 23-valent pneumococcal polysaccharide vaccine (PPV 23) or the 13-valent pneumococcal conjugate vaccine (PCV 13) to prevent CAP (Recommended Level ⅠB), and COVID-19 vaccine should also be recommended in accordance with national guidelines (Recommended Level ⅠA).Recommendation 11:Older individuals should quit smoking, limit alcohol intake, participate in moderate-intensity physical activity (Recommended Level Ⅱ-1A), have regular dental examinations, maintain good nutritional status and personal hygiene, and avoid close contact with children with acute viral respiratory infections (Recommended Level Ⅱ-2A).Recommendation 12:The super-elderly are more likely to experience geriatric syndromes, particularly sarcopenia and frailty, which are closely associated with the occurrence of aspiration pneumonia. Preventing and improving sarcopenia and weakness through nutrition supplement, exercise, cognitive training, etc., can effectively reduce the incidence of pneumonia (Recommended Level ⅢA).Recommendation 13:We recommend that older adults with chronic underlying medical conditions, who are at increased risk of developing pneumonia, should receive personalized management and comprehensive preventive measures to strengthen the management of underlying diseases. Perioperative care for older patients should be optimized to reduce the risk of postoperative pneumonia (Recommended Level ⅢA).

01 Jan 2025·Vaccine

Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naïve Japanese adults: A phase 1 randomized dose-escalation trial

Article

Author: Sebastian, Shite ; Haranaka, Miwa ; Chichili, Gurunadh R ; Malley, Richard ; Oizumi, Yuki ; Borys, Dorota ; Hashimoto, Atsuki ; Nakano, Takashi ; Smulders, Ronald ; Ebara, Masaki ; Iwahana, Mioko ; Nanra, Jasdeep

BACKGROUNDThe burden of pneumococcal diseases remains high in Japan. Pn-MAPS24v is a novel MAPS-based vaccine containing complexes of 24 serotype-specific polysaccharides (PS), non-covalently coupled with fusion protein 1 (CP1). This study evaluated the safety and immunogenicity of different dose levels of Pn-MAPS24v, administered in Japanese adults either subcutaneously (SC) or intramuscularly (IM).METHODSIn this phase 1, dose-escalation, observer-blind trial conducted in Japan, 54 pneumococcal vaccine-naïve adults aged 20-49 years (stage 1), and 72 adults aged 65-85 years (stage 2) were sequentially enrolled. In stage 1, participants were randomized 1:1 (SC:IM) to receive a single Pn-MAPS24v dose at one of the dose levels (1 μg, 2 μg, or 5 μg per PS). In stage 2, participants were randomized 3:1 (Pn-MAPS24v:23-valent pneumococcal polysaccharide vaccine [PPSV23]) and 1:1 (SC:IM) to receive a single dose of either Pn-MAPS24v (one of three dose levels), or PPSV23. Solicited adverse events (AEs) were collected through 7 days post-vaccination, and treatment-emergent AEs (TEAEs) up to 1 month post-vaccination. Serotype-specific opsonophagocytic activity titers and immunoglobulin G (IgG) concentrations, as well as anti-CP1 IgG concentrations were measured before and 1 month post-vaccination.RESULTSNo safety or reactogenicity concerns were identified in any age category across groups. No grade 3-4 TEAEs, serious AEs, or deaths were reported. Regardless of the age category, dose level, administration route, or study vaccine, the frequency of reported TEAEs was low and all vaccine-related TEAEs were mild. Pain, tenderness, and fatigue were the most frequently reported solicited AEs. One month post-vaccination, Pn-MAPS24v induced serotype-specific immune responses that were comparable or higher than those elicited by PPSV23. The immune responses were similar after SC and IM administration.CONCLUSIONPn-MAPS24v showed an acceptable safety profile and was immunogenic after SC and IM administration, therefore supporting the further development of Pn-MAPS24v in Japan.CLINICALTRIALSgov: NCT04265911.

01 Jan 2025·Vaccine

Cost-effectiveness of 15-valent or 20-valent pneumococcal conjugate vaccine for U.S. adults aged 65 years and older and adults 19 years and older with underlying conditions

Article

Author: Leidner, Andrew J ; Kobayashi, Miwako ; Pilishvili, Tamara ; Stoecker, Charles ; Rosenthal, Melissa ; Cho, Bo-Hyun

BACKGROUNDIn June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either 20-valent pneumococcal conjugate vaccine (PCV20) alone or 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all PCV-unvaccinated adults aged ≥65 years (age-based) and for adults aged 19-64 years with conditions that increase the risk for pneumococcal disease (risk-based). This recommendation replaced a previous recommendation for PPSV23 with or without 13-valent pneumococcal conjugate vaccine (PCV13) for these groups.OBJECTIVEWe conducted a cost-effectiveness analysis of age-based and risk-based use of either PCV15 in series with PPSV23 or PCV20 alone when compared to previous recommendations.METHODSWe utilized probabilistic cohort models of all 65-year-olds (age-based) and 19-year-olds (risk-based through age 64 years and age-based at age 65 years). A spreadsheet-based Monte Carlo simulation software was used to estimate immunization costs, medical costs, non-medical costs, and overall disease burden under different vaccine strategies. The model tracked inpatient invasive pneumococcal disease (IPD) and non-bacteremic pneumonia (NBP) in inpatient and outpatient settings. One-way sensitivity analyses incorporated indirect effects of prospective pediatric vaccination with PCV15 and PCV20 on adult IPD and NBP incidence. Costs were reported in 2021 US dollars. All future costs and outcomes were discounted at 3 % per year.RESULTSAge-based use of either PCV20 alone or PCV15 in series with PPSV23 at age 65 years were both shown to be cost-saving (improved health outcomes and saved costs). Combined cost-effectiveness of risk-based (19-64 years) plus age-based (65 years) (risk-and-age-based) use of PCV20 alone was cost-saving, whereas use of PCV15 in series with PPSV23 increased quality-adjusted life years (QALYs) but cost $412,111 (95 % CI: 270,295, 694,869) per QALY gained.CONCLUSIONIn U.S. adults, replacing the previous recommendations with PCV20 alone or PCV15 in series with PPSV23 improved health outcomes. Except for risk-and-age-based use of PCV15 in series with PPSV23 that resulted in increased cost per QALY gained, the interventions also reduced costs.

100 Deals associated with Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

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Indication	Country/Location	Organization	Date
Bacteremia	CN	Beijing Minhai Biological Technology Co., Ltd.	12 Aug 2018
Meningitis	CN	Beijing Minhai Biological Technology Co., Ltd.	12 Aug 2018
Otitis Media	CN	Beijing Minhai Biological Technology Co., Ltd.	12 Aug 2018
Pneumonia	CN	Beijing Minhai Biological Technology Co., Ltd.	12 Aug 2018

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Encephalitis	Phase 2	CN	Beijing Minhai Biological Technology Co., Ltd.	26 Oct 2011
Pneumococcal Infections	Preclinical	CN	Shenzhen Kangtai Biological Products Co., Ltd.	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2006	Not Applicable	HIV Infections	89	23-valent polysaccharide pneumococcal vaccination (Group 1)	tnltwewath(ajugpbwjto) = iuevtlrydg flkcxonnzm (gnaoszntpw ) View more	-	01 Jan 2006
				23-valent polysaccharide pneumococcal vaccination (Group 2)	tnltwewath(ajugpbwjto) = jgcnrcnrtt flkcxonnzm (gnaoszntpw ) View more

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Pneumococcal polysaccharide vaccine 23-valent(Beijing Minhai Biological Technology Co., Ltd.)

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