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Advanced nano-based strategies for mRNA tumor vaccine

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Acta Pharmaceutica Sinica B 2024年第1期14卷 170-189页

作者： Yangqi Qu Jingjing Xu Tong Zhang Qinjun Chen Tao Sun Chen Jiang Key Laboratory of Smart Drug Delivery(Ministry of Education) Minhang HospitalState Key Laboratory of Medical NeurobiologyDepartment of PharmaceuticsSchool of PharmacyFudan UniversityShanghai 201203China

Tumor vaccine is a promising strategy for cancer immunotherapy by introducing tumor antigens into the body to activate specific anti-tumor immune responses.Along with the technological breakthroughs in genetic engineering and delivery systems,messenger ribonucleic acid(mRNA)technology has achieved unprecedented development and application over the last few years,especially the emergency use authorizations of two mRNA vaccines during the COVID-19 pandemic,which has saved countless lives and makes the world witness the powerful efficacy of mRNA technology in vaccines.However,unlike infectious disease vaccines,which mainly induce humoral immunity,tumor vaccines also need to activate potent cellular immunity to control tumor growth,which creates a higher demand for mRNA delivery to the lymphatic organs and antigen-presenting cells(APCs).Here we review the existing bottlenecks of mRNA tumor vaccines and advanced nano-based strategies to overcome those challenges,as well as future considerations of mRNA tumor vaccines and their delivery systems.

关键词： mRNA vaccine Nanoparticle Tumor vaccine Delivery system Stability Targeting Transfection immunogenicity

immunogenicity and reactogenicity of heterologous immunization schedules with COVID-19 vaccines:a systematic review and network meta-analysis

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Chinese Medical Journal 2023年第1期136卷 24-33页

作者： Pei Li Weiwei Wang Yiming Tao Xiaoyu Tan Yujing Li Yinjun Mao Le Gao Lei Feng Siyan Zhan Feng Sun Department of Epidemiology and Biostatistics School of Public HealthPeking UniversityBeijing 100191China National Clinical Research Center for Mental Disorders&Beijing Key Laboratory of Mental Disorders Beijing Anding HospitalCapital Medical UniversityBeijing 100088China Peking University Aerospace School of Clinical Medicine Beijing 100049China Department of Pharmacy First Affiliated Hospital of Fujian Medical UniversityFuzhouFujian 350005China Department of Pharmacology and Pharmacy Centre for Safe Medication Practice and ResearchLi Ka Shing Faculty of MedicineThe University of Hong KongHong KongChina

Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune response.How

关键词： COVID-19 2019-nCoV vaccine mRNA-1273 BNT162 vaccine Vaccination Immunization schedule Antibodies,Neutralizing Heterologous immunogenicity Network meta-analysis

immunogenicity,effectiveness,and safety of COVID‑19 vaccines among children and adolescents aged 2–18 years:an updated systematic review and meta‑analysis

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World Journal of Pediatrics 2023年第11期19卷 1041-1054页

作者： Peng Gao Liang‑Yu Kang Jue Liu Min Liu Department of Epidemiology and Biostatistics School of Public HealthPeking UniversityNo.38Xueyuan RoadHaidian DistrictBeijing 100191China Institute for Global Health and Development Peking UniversityNo.5Yiheyuan RoadHaidian DistrictBeijing 100871China

Background During the coronavirus disease 2019(COVID-19)pandemic,there is an urgent need for safe and effective COVID-19 vaccines to protect children and adolescents.This study aims to provide scientific evidence and recommendations for the application of COVID-19 vaccines in children and adolescents by analyzing the latest studies.Methods We systematically searched MEDLINE(accessed through PubMed),Embase,and Web of Science from January 1,2020,to October 8,2022.Eligible clinical trials,cohort studies,case‒control studies,and cross-sectional studies with extractable data were included in immunogenicity,effectiveness,and safety analyses.According to the heterogeneity,we chose a fixed-effect model(when I2≤50)or a random-effects model(when I2>50)to pool effect values.Results A total of 88 articles were included.The seroconversion rates after the first,second,and third doses of the vaccines were 86.10%,96.52%,and 99.87%,respectively.After the first and second doses,vaccine effectiveness(VE)against severe acute respiratory syndrome coronavirus 2 infection was 42.87%[95%confidence interval(CI)=27.09%–58.65%]and 63.33%(95%CI=52.09%–74.56%),respectively.After the first and second doses,VE against COVID-19 was 60.65%(95%CI=44.80%–76.50%)and 75.77%(95%CI=63.99%–87.56%),respectively.VE against hospitalization due to COVID-19 after the first and second doses was 72.74%(95%CI=51.48%–94.01%)and 82.78%(95%CI=75.78%–89.78%),respectively.The most common adverse events were injection site pain,fatigue/asthenia/tiredness,headache,myalgia/muscle pain,and chills.The incidence rate of myocarditis or pericarditis was 2.42/100,000 people.In addition,the subgroup analysis showed that children aged≤5 years had the lowest incidence of adverse events,and the incidence rate of adverse events was higher for mRNA vaccines than for inactivated vaccines.Conclusions COVID-19 vaccines have good immunogenicity,effectiveness,and safety among children and adolescents.We recommend that children and adolescents be vaccinated as soon as possible to prote

关键词： Children COVID-19 vaccines Effectiveness immunogenicity Safety

immunogenicity and protective efficacy of an inactivated SFTS vaccine candidate in mice

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Biosafety and Health 2022年第1期4卷 45-52页

作者： Aqian Li Xinxian Dai Lei Chen Lin Liu Chuan Li Yang Liu Wei Wu Xiaoxia Huang Jiandong Li Shiwen Wang Mifang Liang Xiuling Li Dexin Li Department of Viral Hemorrhagic Fever National Institute for Viral Disease Control and PreventionChina CDCBeijing 102206China b National Vaccine and Serum Institute Beijing 102206China Suzhou Institute of Systems Medicine Suzhou 215123China China CDC-WIV Joint Research Center for Emerging Diseases and Biosafety Center for Biosafety Mega-ScienceChinese Academy of SciencesWuhan 430071China

Severe fever with thrombocytopenia syndrome(SFTS),caused by a novel identified bunyavirus SFTS virus(SFTSV),was an emerging viral infectious disease that was firstly reported in China.There are no licensed vaccines and therapeutics against SFTSV currently.B‐Propiolactone(BPL)inactivated whole virions of SFTSV strain AH12 were prepared as experimental vaccine in different antigen dose with or without Al(OH)3 adjuvant.The experimental SFTS vaccine was a satisfying immunogen,which could efficiently trigger the development of high levels of SFTSV NP‐specific IgG antibodies and neutralizing antibodies against SFTSV Strain HB29 in BALB/c and C57/BL6 mice,and could induce SFTS virus‐specific cellular immune responses to a certain extent.A single dose of vaccine was immunogenically insufficient in BALB/c mice;the second and third dose resulted in significant boost in antibody response.The use of Al(OH)3 adjuvant resulted in higher antibody titers.The mediate‐dose of vaccine could induce as high and equivalent level of antibody titer as that of high‐dose.The experimental SFTS vaccine in mediate‐and high antigen dose with adjuvant resulted in solid protection of C57/BL6 mice against wild‐type SFTSV challenge with markedly accelerated virus clearance from blood and spleen compared with controls.The experimental SFTS vaccine prepared in this study could efficiently elicit virus specific humoral and cellular immune responses in both BALB/c and C57/BL6 mice,and could protect C57/BL6 mice against SFTS virus challenge.These results supplied evidence that inactivated vaccine was a promising vaccine candidate for the prevention of SFTSV infection.

关键词： SFTS virus Inactivated vaccine immunogenicity Protective efficacy

High VHL Expression Reverses Warburg Phenotype and Enhances immunogenicity in Kidney Tumor Cells

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Genomics, Proteomics & Bioinformatics 2022年第4期20卷 657-669页

作者： Songbiao Zhu Wenxi Ding Yuling Chen Weixuan Wang Renhua Xu Chongdong Liu Xiaohui Liu Haiteng Deng MOE Key Laboratory of Bioinformatics Center for Synthetic and Systematic BiologySchool of Life SciencesTsinghua UniversityBeijing 100084China Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine Guangdong Pharmaceutical UniversityGuangzhou 510006China School of Nursing Binzhou Medical UniversityYantai 264003China Department of Obstetrics and Gynecology Beijing Chao-Yang HospitalCapital Medical UniversityBeijing 100020China

Clear cell renal cell carcinoma(ccRCC)is a frequently occurring renal cancer.The Von Hippel-Lindau disease tumor suppressor VHL,a known tumor suppressor gene,is frequently mutated in about 50%of patients with ccRCC.However,it is unclear whether VHL influences the progression of ccRCC tumors expressing wild-type VHL.In the present study,we found that higher expression of VHL was correlated with the better disease-free survival(DFS)in ccRCC patients using The Cancer Genome Atlas(TCGA)datasets.We revealed that VHL overexpression in ccRCC cells inhibited epithelial-mesenchymal transition(EMT),sterol regulatory elementbinding protein 1(SREBP1)-regulated triglyceride synthesis,and cell proliferation.Proteomic analysis provided us a global view that VHL regulated four biological processes,including metabolism,immune regulation,apoptosis,and cell movement.Importantly,we found that VHL overexpression led to up-regulated expression of proteins associated with antigen processing and interferonresponsive proteins,thus rendering ccRCC cells more sensitive to interferon treatment.We defined an interferon-responsive signature(IRS)composed of ten interferon-responsive proteins,whose m RNA expression levels were positively correlated with DFS in ccRCC patients.Taken together,our results propose that the subset of ccRCC patients with high VHL expression benefit from immunotherapy.

关键词： Renal cancer VHL immunogenicity Multi-omics Interferon

Rabies Virus Neutralizing Activity,Safety,and immunogenicity of Recombinant Human Rabies Antibody Compared with Human Rabies Immunoglobulin in Healthy Adults

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Biomedical and Environmental Sciences 2022年第9期35卷 782-791页

作者： ZHANG Jun Nan MENG Ya Juan BAI Yun Hua LI Yu Feng YANG Li Qing SHI Nian Min HAN Hui Xia GAO Jian ZHU Li Juan LI Shu Ping ZHANG Jing ZHAO Qin Hua WANG Xiu Qin WEI Jing Shuang REN Le Min CAO Chen Hua CHEN Chen ZHAO Wei LI Li Center for Disease Control and Prevention of Chaoyang District Beijing 100021China NCPC New Drug Research and Development Co. Ltd.State Key Laboratory of Antibody Research&DevelopmentShijiazhuang 050015HebeiChina Beijing Institute of Biological Products Beijing 100021China Xiaohongmen Community Healthcare Center Beijing 100023China

Objective Preliminary assessment of rabies virus neutralizing activity,safety and immunogenicity of a recombinant human rabies antibody(NM57)compared with human rabies immunoglobulin(HRIG)in Chinese healthy adults.Methods Subjects were randomly(1:1:1)allocated to Groups A(20 IU/kg NM57),B(40 IU/kg NM57),or C(20 IU/kg HRIG).One injection was given on the day of enrollment.Blood samples were collected on days-7 to 0(pre-injection),3,7,14,28,and 42.Adverse events(AEs)and serious AEs(SAEs)were recorded over a period of 42 days after injection.Results All 60 subjects developed detectable rabies virus neutralizing antibodies(RVNAs)(>0.05 IU/mL)on days 3,7,14,28,and 42.The RVNA levels peaked on day 3 in all three groups,with a geometric mean concentration(GMC)of 0.2139 IU/mL in Group A,0.3660 IU/mL in Group B,and0.1994 IU/mL in Group C.At each follow-up point,the GMC in Group B was significantly higher than that in Groups A and C.The areas under the antibody concentration curve over 0-14 days and 0-42 days in Group B were significantly larger than those in Groups A and C.Fifteen AEs were reported.Except for one grade 2 myalgia in Group C,the other 14 were all grade 1.No SAEs were observed.Conclusion The rabies virus neutralizing activity of 40 IU/kg NM57 was superior to that of 20 IU/kg NM57 and 20 IU/kg HRIG,and the rabies virus neutralizing activity of 20 IU/kg NM57 and 20 IU/kg HRIG were similar.Safety was comparable between NM57 and HRIG.

关键词： Recombinant human rabies antibody NM57 Human rabies immunoglobulin Rabies virus neutralizing activity Safety immunogenicity

Safety and immunogenicity of a third dose of mRNA-1273 vaccine among cancer patients

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Cancer Communications 2023年第7期43卷 749-764页

作者： Anna Giuliano Barbara Kuter Shari Pilon-Thomas Junmin Whiting Qianxing Mo Brett Leav Bradley Sirak Christopher Cubitt Christopher Dukes Kimberly Isaacs-Soriano Kayoko Kennedy Somedeb Ball Ning Dong Akriti Jain Patrick Hwu Jeffrey Lancet Department of Cancer Epidemiology Moffitt Cancer CenterTampaFloridaUSA Moderna CambridgeMassachusettsUSA Department of Immunology Moffitt Cancer CenterTampaFloridaUSA Department of Biostatistics and Bioinformatics Moffitt Cancer CenterTampaFloridaUSA Immune Monitoring Core Moffitt Cancer CenterTampaFloridaUSA Non-Therapeutic Research Office(NTRO) Moffitt Cancer CenterTampaFloridaUSA Department of Malignant Hematology Moffitt Cancer CenterTampaFloridaUSA

Background:Compared to the general population,cancer patients are at higher risk of morbidity and mortality following SARS-CoV-2 infection.The immune response to a two-dose regimen ofmRNA vaccines in cancer patients is generally lower than in immunocompetent individuals.Booster doses may meaningfully augment immune response in this population.We conducted an observational study with the primary objective of determining the immunogenicity of vaccine dose three(100μg)of mRNA-1273 among cancer patients and a secondary objective of evaluating safety at 14 and 28 days.Methods:The mRNA-1273 vaccine was administered~7 to 9 months after administering two vaccine doses(i.e.,the primary series).Immune responses(enzyme-linked immunosorbent assay[ELISA])were assessed 28 days post-dose three.Adverse events were collected at days 14(±5)and 28(+5)post-dose three.Fisher exact or X^(2)tests were used to compare SARS-CoV-2 antibody positivity rates,and paired t-tests were used to compare SARS-CoV-2 antibody geometric mean titers(GMTs)across different time intervals.Results:Among 284 adults diagnosed with solid tumors or hematologic malignancies,dose three of mRNA-1273 increased the percentage of patients seropositive for SARS-CoV-2 antibody from 81.7%pre-dose three to 94.4%28 days post-dose three.GMTs increased 19.0-fold(15.8-22.8).Patients with lymphoid cancers or solid tumors had the lowest and highest antibody titers post-dose three,respectively.Antibody responses after dose three were reduced among those who received anti-CD20 antibody treatment,had lower total lymphocyte counts and received anticancer therapy within 3 months.Among patients seronegative for SARS-CoV-2 antibody pre-dose three,69.2%seroconverted after dose three.A majority(70.4%)experienced mostly mild,transient adverse reactions within 14 days of dose three,whereas severe treatment-emergent events within 28 days were very rare(<2%).Conclusion:Dose three of the mRNA-1273 vaccine was well-tolerated and augmented SARS-CoV-2 seropositivity in cancer patients,especi

关键词： Cancer Coronavirus disease 2019 immunogenicity Observational study Vaccination

immunogenicity and safety of a booster COVID-19 vaccination in patients with chronic liver disease:A multicenter study

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Portal Hypertension & Cirrhosis 2023年第3期2卷 127-135页

作者： Jitao Wang Jingwen Ai Huiling Xiang Yanliang Zhang Zhiyun Hou Qiran Zhang Jiaojian Lv Shubo Chen Chuan Liu Qianqian Li Jing Liang Faren Xie Shujun Jiang Nina Zhang Aiguo Zhang Xiaolin Lan Xuying Zhang Jinlong Li Dengxiang Liu Wenchuan Wang Wei Rao Zhang Qun Qiuju Tian Xiaolong Qi Wenhong Zhang Department of Radiology Center of Portal HypertensionZhongda HospitalSchool of MedicineSoutheast UniversityNanjingJiangsuChina Xingtai Key Laboratory of Precision Medicine for Liver Cirrhosis and Portal Hypertension Xingtai People's Hospital of Hebei Medical UniversityXingtaiHebeiChina Department of Infectious Diseases Huashan Hospital Affiliated to Fudan UniversityShanghaiChina Department of Hepatology and Gastroenterology The Third Central Hospital of TianjinTianjinChina Department of Infectious Diseases Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese MedicineNanjingJiangsuChina Nanjing Research Center for Infectious Diseases of Integrated Traditional Chinese and Western Medicine NanjingJiangsuChina Department of Hepatobiliary Surgery Jincheng People's HospitalJinchengShanxiChina Department of Infectious Diseases Lishui People's HospitalLishuiZhejiangChina Clinal Laboratory Lishui People's HospitalLishuiZhejiangChina Liver Disease Center Organ Transplant CenterAffiliated Hospital of Qingdao UniversityQingdaoShandongChina

Aim:Patients with chronic liver disease(CLD),especially cirrhosis,are at a high risk of severe illness or death from coronavirus disease-2019(COVID-19)and may have a suboptimal immune response to the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)vaccine.This study aimed to evaluate the safety and immunogenicity of the COVID-19 booster vaccination in patients with CLD.Methods:The study protocol was prospectively registered at ClinicalTrials.gov(No.NCT05204602)after approval by the Ethics Committee.Adult participants with CLD were enrolled in this multicenter prospective study.They completed two doses of the inactivated COVID-19 vaccine and received booster doses at least 6 months later.Adverse reactions were recorded within 14 days after the booster dose.Serum samples of the enrolled patients were collected before and after booster vaccination and tested for SARS-CoV-2 receptor-binding domain(RBD)immunoglobulin G and neutralizing anti-bodies.The chi-squared or Fisher's exact test was used to compare categorical data,and the Mann-Whitney U test was used to compare continuous variables.Two-sided p<0.05 were considered statistically significant.Results:In total,63 patients were enrolled from four hospitals in China,including 29 patients with cirrhosis.The median age of all patients was 55 years,and 61.9%(39/63)were male.The vaccines were well tolerated;most adverse reactions were mild and transient,and injection site pain(6.4%;4/63)and fatigue(3.2%,2/63)were the most frequent local and systemic adverse events.Following the booster vaccination,our results showed that in the whole cohort,the levels and positive rates of anti-RBD IgG and neutralizing antibodies were significantly higher than baseline levels(all p<0.05).Conclusions:The inactivated COVID-19 booster vaccine was safe and significantly increased antibody levels and positivity rates following standard vaccination regimens in patients with CLD,especially those with cirrhosis.

关键词： booster vaccine coronavirus disease‐2019 immunogenicity liver disease safety SARS‐CoV‐2

immunogenicity of COVID-19 Vaccination in People Living with HIV:Progress and Challenges

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Infectious Diseases & Immunity 2023年第2期3卷 90-96页

作者： Jin-Wen Song Lili Shen Fu-Sheng Wang Department of Infectious Diseases the Fifth Medical Center of Chinese PLA General HospitalNational Clinical Research Center for Infectious DiseasesBeijing 100039China Department of Clinical Medicine Bengbu Medical CollegeBengbuAnhui 233000China.

The severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection has resulted in numerous confirmed cases and deaths worldwide.Recent studies have shown that people living with HIV(PLWH)are prone to develop severe illness and poor outcomes if they experience coronavirus disease 2019(COVID-19),especially those with uncontrolled viremia and low CD4 T-cell count.Therefore,many countries prioritized PLWH for COVID-19 vaccination.However,lower magnitude or faster waning humoral immune responses elicited by other vaccines have been documented in PLWH,raising concerns regarding the efficacy of the COVID-19 vaccine in these specific populations.Here,we summarize the current progress in the immunogenicity and efficacy of different types of SARS-CoV-2 vaccinations in PLWH and highlight several challenges faced by PLWH in the current COVID-19 pandemics.

关键词： HIV SARS-CoV-2 Vaccine immunogenicity Neutralizing antibody ART