Abstract:
:Cancer immunotherapy has seen a tremendous number of failures and only few recent regulatory successes. This is a review dedicated to determine major regulatory and developmental issues around cancer immunotherapeutics. A three pillar approach should be used in setting a development path: discovery platforms and sufficient pool of validated tumor antigens, product development strategy enabling to bring the product closer to the patient and clinical development strategy accounting for competitive landscape, treatment paradigm, technical and commercial risks. Regulatory framework existing around cancer vaccines in the EU, US, Japan and some developing countries is outlined. In addition, the review covers some specific issues on the design and conduct of clinical trials with cancer vaccines.
journal_name
Hum Vaccin Immunotherjournal_title
Human vaccines & immunotherapeuticsauthors
Kudrin Adoi
10.4161/hv.20518subject
Has Abstractpub_date
2012-09-01 00:00:00pages
1335-53issue
9eissn
2164-5515issn
2164-554Xpii
20518journal_volume
8pub_type
杂志文章,评审abstract::Despite the long-term efficacy and immune persistence observed following HBV vaccination of infants, the need for a booster dose following infant immunization continues to be deliberated. Evidence from HBV booster dose response studies and long-term immunization program reviews are the basis for the recommendation tha...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2018.1462428
更新日期:2018-01-01 00:00:00
abstract::Prophylactic paracetamol administration impacts vaccine immune response; this study ( www.clinicaltrials.gov : NCT01235949) is the first to assess PHiD-CV immunogenicity following prophylactic ibuprofen administration. In this phase IV, multicenter, open-label, randomized, controlled, non-inferiority study in Romania ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1080/21645515.2016.1223001
更新日期:2017-03-04 00:00:00
abstract::Variations of post-translational modifications are important for stability and in vivo behavior of therapeutic antibodies. A recombinant humanized anti-cocaine monoclonal antibody (h2E2) was characterized for heterogeneity of N-linked glycosylation and disulfide bonds. In addition, charge heterogeneity, which is parti...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/21645515.2014.990856
更新日期:2015-01-01 00:00:00
abstract::Human papillomavirus is considered the causative factor for cervical cancer, which accounts for approximately 5% of the global cancer burden and more than 600,000 new cases annually that are attributable to HPV infection worldwide. The first-generation prophylactic HPV vaccines, Gardasil® and Cervarix®, were licensed ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2017.1346755
更新日期:2017-10-03 00:00:00
abstract::A new live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) has been developed based on innovative technology to give protection against JE with an improved immunogenicity and safety profile. In this phase 3, observer-blind study, 274 children aged 12-24 months were randomized 1:1 to receive one dose of...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.4161/hv.29743
更新日期:2014-01-01 00:00:00
abstract::The aim of this Phase IIIb, open-label, randomized study was to demonstrate the non-inferiority of immune responses and to assess the safety of a purified chick-embryo cell rabies vaccine (PCECV) in healthy Chinese children (6 to 17 years) and older adults (≥51 years) following 2 alternative intramuscular (IM) simulat...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,随机对照试验
doi:10.4161/21645515.2014.994460
更新日期:2015-01-01 00:00:00
abstract::Individuals fail to elicit protective antibody after hepatitis B vaccination remain at risk for hepatitis B virus infection. Analysis of the transcriptome of peripheral blood mononuclear cells (PBMCs) is essential to elucidate the characteristics of gene expression in non-responders. In this study, we enrolled seven r...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2018.1450122
更新日期:2018-07-03 00:00:00
abstract::Similar features between the immune system of healthy elderly people and of younger individuals subjected to conditions of chronic immune activation are progressively being observed. This is raising the hypothesis that chronic immune activation may cause the premature aging of the immune system. Here we dissect this t...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.28698
更新日期:2014-01-01 00:00:00
abstract::Malaria has long been recognized as a public health problem. At the community level, vector control, and antimalarial medicines are the main means for reducing incidence, morbidity, and mortality of malaria. A vaccine not only would bring streamlining in the prevention of morbidity and mortality from malaria but also ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.28482
更新日期:2014-01-01 00:00:00
abstract::Human papilloma viruses (HPVs) infect the skin and mucosal epithelium of both men and women. There are about 100 types of HPVs, which are differentiated by the genetic sequence of the outer capsid protein L1. More than 30 types of HPVs are sexually transmitted. Most cases of carcinoma of the cervix are caused by HPV. ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.22063
更新日期:2013-01-01 00:00:00
abstract::Human papillomavirus (HPV) can cause genital warts and HPV-related cancer.People living with human immunodeficiency virus (HIV)are more symptomatic for HPV infections.Campos dos Goytacazes,a municipality of Rio de Janeiro,introduced the quadrivalent HPV vaccine (4vHPV)for HIV-positive women four years before initiatio...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1799666
更新日期:2020-09-22 00:00:00
abstract:OBJECTIVE:To study the awareness and acceptance of human papillomavirus (HPV) vaccination among sexually active men having sex with men (MSM) and men not having sex with men (MNSM) attending the largest sexual health clinic in Wuxi, China. METHODS:A questionnaire about participants' socio-demographic characteristics a...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2015.1099771
更新日期:2016-06-02 00:00:00
abstract::Tuberculosis (TB) is a significant cause of illness and death worldwide. Immunotherapy has been investigated in the treatment of TB. The purpose of this study was to perform a meta-analysis investigating the effectiveness of the M. vaccae vaccine. Medline, Cochrane, EMBASE, and Google Scholar were searched until Novem...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1080/21645515.2017.1335374
更新日期:2017-09-02 00:00:00
abstract::WHO defines adolescence age between 10 to 19 years. In India, there are 243 million adolescents which constitute 21 per cent of the total population. The global burden of disease in adolescents (2011) reports that the total number of disability adjusted life years (DALYs) worldwide among adolescents were 230 million w...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.29757
更新日期:2015-01-01 00:00:00
abstract::Vaginal and vulvar cancers do not account for a large proportion of gynecologic malignancies but their impact is significant. Both vaginal and vulvar lesions have precursors and display levels of dysplasia before progression to invasive disease. Human Papillomavirus (HPV) is a known causative agent of such dysplasia a...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2016.1147634
更新日期:2016-06-02 00:00:00
abstract::Sipuleucel-T, the first autologous active cellular immunotherapy approved by the United States Food and Drug Administration, is designed to stimulate an immune response to prostate cancer. Sipuleucel-T is manufactured by culturing a patient's peripheral blood mononuclear cells (including antigen presenting cells) with...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.18769
更新日期:2012-04-01 00:00:00
abstract::This article aims to explore the trends of monoclonal antibodies (mAbs) research and commercialization, mainly to examine the development trajectories by a contrastive exploration of successful and unsuccessful mAb. This work is based on two sets of R&D project reports, consisting of 517 discontinued mAb project repor...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2017.1420445
更新日期:2018-04-03 00:00:00
abstract::HIV-infected patients are 30- to 100-fold more susceptible to invasive pneumococcal diseases than are healthy adults. Pneumococcal vaccination may be the best way to decrease the large pneumococcal disease burden, but the optimal timing of vaccination is still unclear. In this study, HIV-infected subjects aged ≥18 yea...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2019.1643677
更新日期:2020-01-01 00:00:00
abstract::The purpose of this study is to mine CAR-T patents and therapies under development, to design a landscape of the sector and to understand key therapy segments and their current trends. The study analyzed the entire market, consisting of 1624 patent families and 509 biologics under development, to depict an overview of...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2019.1689744
更新日期:2020-06-02 00:00:00
abstract::Novel coronavirus disease 2019 (COVID-19) is caused by the SARS-CoV-2 virus, which belongs to the genus Coronaviridae with its high mutation rate. From the current perspective, we discuss the current status of COVID-19, new challenges, and potential interventions to control the pandemic in developing counties such as ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1766939
更新日期:2020-10-02 00:00:00
abstract::The licensed meningococcal serogroup B vaccine, 4CMenB (Bexsero(®)), contains recombinant membrane proteins (rMenB) and outer membrane vesicles (OMV) of the New Zealand serogroup B strain. We investigated whether reducing the OMV and/or protein content influences 4CMenB immunogenicity and reactogenicity in healthy two...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.4161/hv.29218
更新日期:2014-01-01 00:00:00
abstract::Background: Rubella continues to be a leading cause of vaccine-preventable congenital birth defects and permanent organ damage, especially in developing countries. For women who are infected with the rubella virus (RV) before conception or during the first trimester of pregnancy, the unborn child has up to a 90% proba...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1729027
更新日期:2020-10-02 00:00:00
abstract::Paralytic poliomyelitis is a disease that became a public health issue at the beginning of the twentieth century and was more or less eliminated in developed countries by the early 1970s. The Global Polio Eradication Initiative of WHO has now eradicated endemic polio from all but three countries although re-introducti...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/21645515.2014.981115
更新日期:2014-01-01 00:00:00
abstract::Few studies in China focused on serotypes of Streptococcus pneumoniae in patients with invasive pneumococcal disease (IPD). We aimed at investigating the serotype distribution for IPD-causing S. pneumoniae and vaccine coverage among Chinese children and adults. This was a multicenter, observational study to collect S....
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1757996
更新日期:2020-06-12 00:00:00
abstract::The relationship between obesity and vaccine efficacy is a serious issue. Previous studies have shown that vaccine efficacy is lower in the obese than in the non-obese. Here, we examined the influence of obesity on the efficacy of influenza vaccination using high fat diet (HFD) and regular fat diet (RFD) mice that wer...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.28332
更新日期:2014-01-01 00:00:00
abstract::S. aureus and S. pneumoniae are both common pathogens that are also carried by a large proportion of healthy individuals in the nasal and nasopharyngeal spaces. A negative association between carriage of S. aureus and S. pneumoniae has been reported in children in various epidemiologic studies from different geographi...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2015.1081321
更新日期:2016-01-01 00:00:00
abstract::The immune system responds to tumor cells. The challenge has been how to effectively use these responses to treat or protect against cancer. Toward the goal of developing a cancer vaccine, we are pursuing methodologies for the discovery and testing of useful antigens. We present an array-based approach for discovering...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.25634
更新日期:2013-10-01 00:00:00
abstract::The multicomponent meningococcal serogroup B vaccine, 4CMenB, has demonstrated effectiveness in preventing invasive MenB disease in infants and in controlling MenB outbreaks. The need for/timing of additional booster doses is not yet established. We reviewed eight studies that evaluated antibody persistence and booste...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2019.1627159
更新日期:2019-01-01 00:00:00
abstract::Abrin, obtained from the seeds of Abrus precatorius plant, is a potent toxin belonging to the family of type II ribosome-inactivating proteins. Recently, a recombinant vaccine consisting of the A subunits of abrin and its homolog Abrus precatorius agglutinin (APA) was demonstrated to protect mice from abrin lethality....
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2015.1067741
更新日期:2016-01-01 00:00:00
abstract::Despite strong national recommendations to vaccinate adolescents against the human papillomavirus (HPV), only 14% of teenage girls completed all 3 doses in 2010. Parental hesitancy may be one of the strongest reasons behind this low uptake rate. This review investigates sources of parental hesitancy including parental...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.26224
更新日期:2013-12-01 00:00:00