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Novel polysaccharide-protein conjugates provide an immunogenic 13-valent pneumococcal conjugate vaccine for ***

Synthetic and Systems Biotechnology 2017年第1期2卷 49-58页

作者： Allison E.B.Turner Jonas E.Gerson Helen Y.So Daniel J.Krasznai Adrienne J.St.Hilaire Donald F.Gerson vaccine research and Development PnuVax Incorporated Headquarters134 Albert St.KingstonOntarioK7L 3V2Canada vaccine research and Development PnuVax Incorporated Laboratories6000 Royalmount Ave.MontrealQuebecH4P 2T1Canada

Pneumonia remains the single leading cause of childhood death *** the commercial availability of multiple pneumococcal conjugate vaccines(PCVs),high dosage cost and supply shortages prevent PCV delivery to much of the developing *** current work presents high-yield pneumococcal conjugates that are immunogenic in animals and suitable for use in human vaccine *** 13-valent pneumococcal conjugate vaccine(PCV-13)investigated in this research incorporated serotypes 1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F,and *** polysaccharides(PnPSs)and CRM197 carrier protein were produced and purified in-house,and used to prepare PnPS-CRM conjugates using unique,cyanide-free,in vacuo glycation conjugation *** vitro characterization confirmed the generation of higher molecular weight PnPS-CRM conjugates low in free *** vivo animal studies were performed to compare PnuVax's PCV-13 to the commercially available PCV-13,Prevnar®13(pfizer,USA).A boost dose was provided to all groups post-dose 1 at t?14 ***-dose 2 results at t?28 days showed that all 13 serotypes in PnuVax's PCV-13 were *** serotype IgG GMCs demonstrated that PnuVax's PCV-13 is immunogenic for all 13 serotypes,with 10 of the 13 serotypes statistically the same or higher than Prevnar®13 post-dose *** a result,the novel polysaccharideprotein conjugates developed in this work are highly promising for use in human PCV *** in vacuo conjugation technique applied in this work could also be readily adapted to develop many other conjugate vaccines.

关键词： Pneumonia vaccine development PCV Pneumococcal conjugate vaccine Polysaccharide Carrier protein In vacuo glycation

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Safety of a 13-Valent Pneumococcal Conjugate vaccine in Elderly Adults Previously Immunized with a 23-Valent Pneumococcal Polysaccharide vaccine: An Open-Label Trial

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World Journal of vaccines 2013年第4期3卷 123-129页

作者： Tino F. Schwarz Karlis Pauksens Christine Juergens Deepthi Jayawardene Daniel A. Scott William C. Gruber Beate Schmoele-Thoma Central Laboratory and Vaccination Centre Stiftung Juliusspital Würzburg Germany Department of Medical Sciences Section of Infectious Diseases Uppsala University Akademiska Sjukhuset Uppsala Sweden pfizer Inc. Collegeville USA pfizer Pharma GmbH Berlin Germany pfizer vaccine research Pfizer Pearl River USA

An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13. 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain-Barré syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)

关键词： 13-Valent Pneumococcal Conjugate vaccine 23-Valent Pneumococcal Polysaccharide vaccine Streptococcus pneumoniae Reactogenicity Safety

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Safety and Immunogenicity of Two RNA-Based Covid-19 vaccine Candidates

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四川生理科学杂志 2021年第1期43卷 105-105页

作者： Edward E Walsh From the University of Rochester and Rochester General Hospital Rochester (E.E.W. A.R.F.) Vaccine Research and Development Pfizer Pearl River (J.A. A.G. K.A.S. K.K. W.K. D.C. K.R.T. P.R.D. K.U.J. W.C.G.) and New York University Langone Vaccine Center and Grossman School of Medicine New York (M.J.M. V.R.) — all in New York Cincinnati Children’s Hospital Cincinnati (R.W.F.) vaccine research and Development Pfizer Hurley United Kingdom (N.K. S.L. R.B.) the University of Maryland School of Medicine Center for Vaccine Development and Global Health Baltimore (K.N. K.E.L.) vaccine research and Development Pfizer Collegeville PA (P.L.) the University of Texas Medical Branch Galveston (C.F.-G. P.-Y.S.) and BioNTech Mainz Germany (ÖT. U.Ş.).

Background:Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infections and the resulting disease,coronavirus disease 2019(Covid-19),have spread to millions of persons *** vaccine candidates are under development,but no vaccine is currently *** safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States.

关键词： vaccine acute respiratory

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Selection of Adjuvants for Enhanced vaccine Potency

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World Journal of vaccines 2011年第2期1卷 33-78页

作者： Wei Wang Manmohan Singh BioTherapeutics Pharmaceutical Sciences Pfizer Inc 700 Chesterfield Parkway West Chesterfield MO 63017 Novartis vaccines and Diagnostics 45 Sidney St Cambridge MA 02139

The advent of mass vaccination has saved millions of human lives and revolutionized the quality of life. Vaccination is currently one of the most cost effective ways of managing healthcare costs in both emerging and developed countries. Despite the long vaccine history and success, design and development of efficacious and safe vaccines has been tradi-tionally semi-empirical. This is mainly due to our limited understanding of vaccination mechanism and its influencing factors. The most important factor is arguably the type and concentration of vaccine adjuvants. Until recently, however, only one type of adjuvant – aluminum salts, had been widely used within licensed human vaccines in the US, even though a variety of novel adjuvants have been evaluated in the past few decades. This review summarizes the key adju-vants that have been evaluated in recent years with an intention to facilitate more efficient development of vaccine products to combat human diseases.

关键词： Adjuvant Alum Aluminum Salts Immune Response

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Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

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四川生理科学杂志 2021年第10期43卷 1819-1819页

作者： Arabella S V Stuart Oxford vaccine Group Department of Paediatrics University of Oxford Oxford UK Oxford University Hospitals NHS Foundation Trust Oxford UK Oxford vaccine Group Department of Paediatrics University of Oxford Oxford UK Statistics Modelling and Economics Department UK Health Security Agency London UK Immunisation and Countermeasures Division National Infection Service UK Health Security Agency London UK Public Health Scotland Glasgow Scotland UK UK Health Security Agency Porton Down Salisbury UK Liverpool School of Tropical Medicine Liverpool UK Department of Infection Immunity and Cardiovascular Disease University of Sheffield Sheffield UK Department of Infection and Tropical Medicine Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne UK Translational and Clinical research Institute Newcastle University Newcastle UK NIHR Southampton Clinical research Facility and Biomedical research Centre University Hospital Southampton NHS Foundation Trust Southampton UK Faculty of Medicine and Institute for Life Sciences University of Southampton Southampton UK School of Population Health Sciences and School of Cellular and Molecular Medicine University of Bristol Bristol UK Department of Infection and NIHR BRC Guy's and St Thomas' NHS Foundation Trust London UK MRC Clinical Trials Unit University College London London UK NIHR/Wellcome Trust Clinical research Facility University Hospitals Birmingham NHS Foundation Trust Birmingham UK Institute of Microbiology and Infection University of Birmingham Birmingham UK The vaccine Institute St George's University of London London UK Oxford vaccine Group Department of Paediatrics University of Oxford Oxford UK Chinese Academy of Medical Science Oxford Institute University of Oxford Oxford UK North Bristol NHS Trust Bristol UK NIHR UCLH Clinical research Facility and NIHR UCLH Biomedical research Centre University College London Ho

Background:Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment,we studied mixed priming schedules incorporating an adenoviral-vectored vaccine(ChAdOx1 nCoV-19[ChAd],AstraZeneca),two mRNA vaccines(BNT162b2[BNT],pfizer-BioNTech,and mRNA-1273[m1273],Moderna)and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant(NVX-CoV2373[NVX],Novavax).

关键词： pfizer schedule COV

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Potential for Maternally Administered vaccine for Infant Group B Streptococcus

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四川生理科学杂志 2023年第8期45卷 1384-1384页

作者： Shabir A Madhi From the South African Medical research Council vaccines and Infectious Diseases Analytics research Unit (S.A.M. R. Strehlau A.I. G.K. S.J. L.J.) the Department of Paediatrics and Child Health Faculty of Health Sciences Rahima Moosa Mother and Child Hospital (R. Strehlau) and Wits RHI Faculty of Health Sciences University of the Witwatersrand (L.F.) Johannesburg the Division of Neonatal Medicine School of Child and Adolescent Health Faculty of Health Sciences University of Cape Town and Mowbray Maternity Hospital Cape Town (A.M.N.) the Clinical Neonatology Unit Prince Mshiyeni Memorial Hospital (N.N.) and the Department of Medical Microbiology National Health Laboratory Services Prince Mshiyeni Memorial Hospital and College of Health Sciences University of KwaZulu-Natal (Y.R.) Durban the University of Pretoria and the Tshwane Academic Division National Health Laboratory Services Pretoria (M.S.) and the Family Center for Research with Ubuntu Department of Paediatrics and Child Health Stellenbosch University Stellenbosch (S.L.B.) — all in South Africa and vaccine research and Development Pfizer Pearl River NY (A.S.A. J.A. D.R. R. Simon B.J. R.N. S.M. Z.J. D.P. N.C.S.M. E.G. J.L.P. D.A.S. W.C.G. K.U.J.).

Background:Natural history studies have correlated serotype-specific anti-capsular polysaccharide(CPS)IgG in newborns with a reduced risk of group B streptococcal disease.A hexavalent CPS-cross-reactive material 197 glycoconjugate vaccine(GBS6)is being developed as a maternal vaccine to prevent invasive group B streptococcus in young ***:In an ongoing phase 2,placebo-controlled trial involving pregnant women,we assessed the safety and immunogenicity of a single dose of various GBS6 formulations and analyzed maternally transferred anti-CPS *** a parallel seroepidemiologic study that was conducted in the same population,we assessed serotype-specific anti-CPS IgG concentrations that were associated with a reduced risk of invasive disease among newborns through 89 days of age to define putative protective thresholds.

关键词： protective transferred conjugate

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SARS-CoV-2 variants:A continuing threat to global health

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Asian Pacific Journal of Tropical Medicine 2022年第1期15卷 1-3页

作者： Balamurugan Shanmugaraj Narach Khorattanakulchai Waranyoo Phoolcharoen Baiya Phytopharm Co. LtdBangkok10250Thailand research Unit for Plant-produced Pharmaceuticals Chulalongkorn UniversityBangkok10330Thailand Department of Pharmacognosy and Pharmaceutical Botany Faculty of Pharmaceutical SciencesChulalongkorn UniversityBangkok10330Thailand

Coronavirus disease 2019(COVID-19)is an acute respiratory illness caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2).COVID-19 pandemic has an unprecedented impact on economy,trade and human lifestyle *** the emergence of of SARS-CoV-2,more than 266 million infections and 5260888 deaths were reported globally over the last two years[1].The scientific achievements particularly in last two years yielded effective vaccines against COVID-19.A variety of platform technologies including protein subunit,viral vector,RNA,inactivated and DNA are being employed to develop effective *** date,vaccines that have been approved against COVID-19 include the pfizer BioNTech(mRNA vaccine),Oxford-AstraZeneca(viral vector vaccine),Moderna(mRNA vaccine),Janssen ***2.S(viral vector),Sinopharm,Sinovac-CoronaVac,Bharat Biotech’s Covaxin(inactivated virus vaccines),*** of December 2021,over 8 billion doses of COVID-19 vaccines have been administered globally[1].The details on the number of COVID-19 confirmed cases and global vaccination coverage are provided in Figure 1.

关键词： pfizer doses globally

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SARS-CoV-2 infection rates after different vaccination schemes:An online survey in Turkey

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Asian Pacific Journal of Tropical Medicine 2022年第4期15卷 171-178页

作者： Oya Baydar Toprak Sennur Ozen Berker Ozturk Burcu Ozturk Ebru Ozturk Mehmet Kitapci Nurdan Kokturk Chest Diseases Department Faculty of MedicineCukurova UniversityAdanaTurkey Department of Pulmonary Medicine Delta HospitalIstanbulTurkey Chest Diseases Department Aksaray Training and Research HospitalAksarayTurkey Department of Pulmonary Medicine Faculty of MedicineGazi UniversityAnkaraTurkey Department of Biostatistics Hacettepe UniversityAnkaraTurkey Department of Nuclear Medicine Integra Medical Imaging CenterAnkaraTurkey

Objective:To identify effects of various nationwide vaccination protocols on the evolution of new SARS-CoV-2 infections among adult population and to evaluate the safety of mRNA(BioNTech/pfizer)***:Totally 10735 adult volunteers that received at least one dose of BioNTech/pfizer or triple doses of CoronaVac participated in this cross-sectional-online survey between 1 and 10 September *** information was collected covering a 5-month period from April 2021 to September *** about people who were vaccinated with only single and double dose CoronaVac were not included in this ***:At least one side effect after single and double dose of BioNTech/pfizer and triple doses of CoronaVac were observed in 42.1%,42.5%and 10.9%,*** most common side effects were shoulder/arm pain,weakness/fatigue,muscle/joint pain and *** side effects were the most frequent in single BioNTech/pfizer,while it was the least in triple *** rate of positive PCR tests before vaccination was 17.6%,and decreased to 3.0%after *** rates of positive SARS CoV-2-PCR were 18.8%,3.5%,3.1%,0.5%and 4.6%in single BioNTech/pfizer,double BioNTech/pfizer,double CoronaVac+single BioNTech/pfizer,double CoronaVac+double BioNTech/pfizer and triple CoronaVac,*** 1.8%of PCR positive COVID-19 cases needed intensive unit care in the pre-vaccination period,intensive care unit was required in 0%,1.5%,2.4%,0%and 4.2%after single BioNTech/pfizer,double BioNTech/pfizer,double CoronaVac+single BioNTech/pfizer,double CoronaVac+double BioNTech/pfizer and triple CoronaVac,*** rate after vaccination was 0.4%.Conclusions:The rarity of COVID-19 infection after vaccination suggests that efficacy of vaccines is *** the other hand,the data underscore the critical importance of continued public health mitigation.

关键词： mRNA vaccine COVID-19 SARS-CoV-2 vaccine schemes Reinfection Positivity rate after vaccination

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Examination of Homologies between COVID-19 vaccines and Common Allergens:The Potential for T Cell-mediated Responses for Allergic Rhinitis and Asthma

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Infectious Diseases & Immunity 2022年第4期2卷 282-284页

作者： Micah Hartwell Benjamin H.Greiner Savannah Nicks Oklahoma State University Center for Health Sciences Department of Psychiatry and Behavioral SciencesTulsaOklahomaUnited States Oklahoma State University Center for Health Sciences Office of Medical Student ResearchTulsaOklahomaUnited States University of Texas Medical Branch Department of Internal MedicineGalvestonTexasUnited States

As the SARS-CoV-2 virus shares relatively large protein sequences homologous to grass pollens,dust mites,and molds,our objective was to assess the potential overlap between the COVID-19mRNA vaccines frompfizer-BioNtech andModerna and known *** found 7 common allergens with potential for cross-reactivity with the pfizer vaccine and 19 with theModerna vaccine,including common grasses,molds,and dust mites.T-cell mediated antigen cross-reactivity between viruses and allergens is a relatively new area of study in clinical immunology;a discipline that may be particularly useful regarding the SARS-CoV-2 virus and the allergic response in *** results suggest that vaccination with the pfizer-BioNtech andModerna COVID-19 vaccinesmay contribute to T-cell cross-reactivity with allergens that impact allergic asthma and allergic *** research should assess the clinical implications of COVID-19 vaccination on the severity and symptomatology of the allergic disease,in addition to natural viral infection.

关键词： Rhinitis,allergic Allergy COVID-19 Cross-reactivity mRNA vaccines

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Evolution of Acquired Humoral Immunity after Full Vaccination against SARS-CoV-2. IgG Levels in Healthcare Workers at 6 and 9 Months

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World Journal of vaccines 2023年第2期13卷 13-32页

作者： Victoria Delicado-Useros Esther Navarro-Rodenas Indalecio-M Sánchez-Onrubia Carmen Ortega-Martínez Antonia Alfaro-Espín Juan-D Pérez-Serra Francisco García-Alcaraz Julia Lozano-Serra Lorena Robles-Fonseca Teresa Pérez-Domenech Nursing Faculty Castilla-La Mancha University Nursing & Society Research Group Albacete Spain Emergency Department General Hospital Almansa Spain Emergency Department General Hospital Albacete Spain Nursing Faculty Nursing & Society Research Group Universidad de Castilla-La Mancha Albacete Spain Emergency Department Son Espasses Universitary Hospital Palma de Mallorca Spain Departament of Clinical Microbiology in Albacete General Hospital Albacete Spain

Background: The COVID-19 pandemic continues to be a major worldwide health problem. The present study aims to contribute to surveillance of the immune and clinical response of vaccines to SARS-CoV-2. Methods: Observational medication study on acquired immunity and effectiveness of vaccines. Population: 620 workers in the health service of Almansa (Spain). Representative sample of 150 individuals. Sociodemographic, clinical, and epidemiological data and samples were recorded to determine anti-SARS-CoV-2 serum IgG levels 6 and 9 months after vaccination with pfizer. Results: Mean age 46.45 years;76% women;85.1% working in a hospital. 19.3% had had COVID-19 in the year prior to vaccination. 96.7% were fully vaccinated with pfizer/BioNTech. At 6 months, 100% seropositivity and mean IgG levels of 3017.2 AU/ml. Significant variations in IgG levels in individuals with prior COVID-19 infection and smokers. At 9 months, 99.3% remained seropositive;2.8% infected after vaccination. The repeated measures analysis showed a difference in means of 669.0 AU/ml (significant decrease in IgG levels of 28.9%). Conclusion: Antibody levels remained positive 6 and 9 months after vaccination, although IgG levels were found to decay.

关键词： Acquired Immunity SARS-CoV-2 vaccine IgG level Healthcare Workers COVID-19 Incidence Rate

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