Abstract:
:We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China. Healthy adults aged 18-45 y (n=48) and children aged 2-6 y (n=50) received a single dose of the human RV vaccine or placebo. Healthy infants (n=50) aged 6-16 weeks at the time of first vaccination received two oral doses of the human RV vaccine or placebo according to a 0, 1 mo schedule. In infants, blood samples were collected prior to vaccination and one month post-dose 2 to assess anti-RV IgA antibody concentrations using ELISA. Stool samples were collected from all infants on the day of each vaccination, at 7 and 15 d after each vaccination and one month post-dose 2. Stool samples were analyzed by ELISA for detection of RV antigen to assess RV antigen excretion. The reactogenicity profile of the human RV vaccine was found to be comparable to that of placebo in all age groups studied. The anti-RV IgA antibody seroconversion rate in infants after two vaccine doses was 86.7% (95% CI: 59.5-98.3). Vaccine take in infants who received the liquid human RV vaccine was 86.7% (95% CI: 59.5-98.3). A Phase III efficacy study of the human RV vaccine in the infant population in China has now been completed (ROTA-075/NCT01171963).
journal_name
Hum Vaccin Immunotherjournal_title
Human vaccines & immunotherapeuticsauthors
Li RC,Li YP,Mo ZJ,Luo D,Huang T,Kong JL,Wang LH,Song NS,Liu A,Zhang H,Liao X,Karkada N,Han HHdoi
10.4161/hv.25076subject
Has Abstractpub_date
2013-08-01 00:00:00pages
1638-42issue
8eissn
2164-5515issn
2164-554Xpii
25076journal_volume
9pub_type
杂志文章,随机对照试验abstract::Background: Despite long standing recommendations of pneumococcal and influenza vaccination for adults age 65 years and older and wide-spread availability to vaccination services, vaccination coverage in the United states is low. We sought to explore reasons patients reportedly did not receive these vaccines.Methods: ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2019.1688033
更新日期:2020-05-03 00:00:00
abstract::One of the main challenges in early clinical research with respiratory syncytial virus (RSV) live-attenuated vaccines (LAVs) is to assess immunogenicity in healthy adults. Healthy adults will have preexisting levels of serum neutralizing antibodies that could prematurely neutralize the LAV and underestimate the potent...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2019.1688040
更新日期:2020-06-02 00:00:00
abstract::Maternal immunization holds tremendous promise to improve maternal and neonatal health for a number of infectious conditions. The unique susceptibilities of pregnant women to infectious conditions, as well as the ability of maternally-derived antibody to offer vital neonatal protection (via placental transfer), togeth...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/21645515.2014.970901
更新日期:2014-01-01 00:00:00
abstract::Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease, but no broadly protective vaccine is yet approved. We assessed the safety and immunogenicity of a bivalent MnB vaccine composed of lipidated subfamily A and B variants of recombinant LP2086 (rLP2086, also known as factor...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,随机对照试验
doi:10.4161/hv.19983
更新日期:2012-07-01 00:00:00
abstract::Monoclonal antibody preparations have demonstrated considerable clinical utility in the treatment of specific malignancies, as well as inflammatory and infectious diseases. Antibodies are conventionally delivered by passive administration, typically requiring costly large-scale laboratory development and production. A...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.26498
更新日期:2013-10-01 00:00:00
abstract::Based on an increasingly extensive literature expressing the large interest in the field, this paper gives an overview of different aspects of influenza prevention in children. It relies on paradoxes. First, the heaviest part of the burden is well demonstrated in the youngest infants by numerous epidemiological data e...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.8.1.18278
更新日期:2012-01-01 00:00:00
abstract::Raising high titer antibodies in animals is usually performed by protein immunization, which requires the long and sometimes difficult step of production of the recombinant protein. DNA immunization is an alternative to recombinant proteins, only requiring the building of an eukaryotic expression plasmid. Thanks to ef...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.25192
更新日期:2013-10-01 00:00:00
abstract::Measles virus (MV) is the only human virus within the morbillivirus genus of the Paramyxoviridae. The veterinary members are canine distemper virus (CDV), peste des petits ruminants virus (PPRV), Rinderpest Virus (RPV) as well as the marine morbilliviruses phocine distemper virus (PDV), dolphin morbillivirus (DMV) and...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2017.1403677
更新日期:2018-01-02 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:BACKGROUND:Adolescents are the primary target population for human papillomavirus (HPV) vaccination. The objective of this study is to explore the acceptability of HPV vaccines and evaluate factors related to willingness to be vaccinated among Chinese adolescents. METHODS:A nation-wide survey was conducted across 14 s...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1812314
更新日期:2020-10-29 00:00:00
abstract::Psoriasis is a chronic, immune skin disease associated with significant morbidity. Development of psoriasis is influenced by numerous genes, one allele is HLA-CW*0602. Other genes and single nucleotide polymorphisms affect immunologic pathways and antimicrobial peptide synthesis. Dendritic cells initiate psoriasis by ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.27532
更新日期:2014-01-01 00:00:00
abstract::Although catch-up campaigns (CCs) at the introduction of pneumococcal conjugate vaccines (PCVs) may accelerate their impact, supply constraints may limit their benefit if the need for additional PCV doses results in introduction delay. We studied the impact of PCV13 introduction with and without CC in Nha Trang, Vietn...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2018.1467201
更新日期:2018-01-01 00:00:00
abstract::The present study evaluated the safety and immunogenicity of the 2013/2014 trivalent surface antigen inactivated subunit seasonal influenza virus vaccine Fluvirin® in healthy adults (18 - ≤ 60 years) and elderly (>60 years). The vaccine contained 15 µg haemagglutinin protein from each of influenza A/California/7/2009 ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2015.1064570
更新日期:2015-01-01 00:00:00
abstract::Pertussis is a highly contagious respiratory disease caused by Bordetella pertussis. However, after the introduction of the whole-cell pertussis vaccine (wP), the annual incidence rates of the disease progressively declined. Despite this result, the inclusion of wP in the national immunization schedule of infants and ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2018.1480298
更新日期:2018-01-01 00:00:00
abstract::HIV-specific T-cell responses play a key role in controlling HIV infection, and therapeutic vaccines for HIV that aim to improve viral control will likely need to improve on the T-cell responses induced by infection. However, in the setting of chronic infection, an effective therapeutic vaccine must overcome the enorm...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2018.1448328
更新日期:2018-07-03 00:00:00
abstract::Hepatitis E virus (HEV) infection is one of the main causes of acute hepatitis worldwide. A recombinant hepatitis E vaccine, HEV 239, has been licensed in China for immunizing adults of 16 y old and above. The vaccine antigen contains pORF2 aa 368 - 606 of the HEV genotype 1 expressed in E. coli. The quality of the va...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2015.1008870
更新日期:2015-01-01 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:BACKGROUND:The study was aimed at comparative evaluation of seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP® for immunogenicity and safety in the course of clinical trial phase II on healthy subjects up to 60 years. METHODS:The trial involved 150 subjects in randomized 2:1 groups that received eith...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2019.1705691
更新日期:2020-08-02 00:00:00
abstract::The rapid evolution of influenza A viruses poses a great challenge to vaccine development. Analytical and machine learning models have been applied to facilitate the process of antigenicity determination. In this study, we designed deep convolutional neural networks (CNNs) to predict Influenza antigenicity. Our model ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2020.1734397
更新日期:2020-11-01 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::Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines. Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicin...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.34360
更新日期:2015-01-01 00:00:00
abstract::A universal vaccine that provides long-lasting protection from both epidemic and pandemic influenza viruses remains the "holy grail" of influenza vaccine research. Though virus neutralization assays are the current benchmark of measuring vaccine effectiveness, it is clear that Fc-receptor functions can drastically imp...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2017.1290018
更新日期:2017-06-03 00:00:00
abstract::The introduction of a serogroup A meningococcal conjugate vaccine in the African meningitis belt has been a remarkable success. Meningitis due to the serogroup A meningococcus, previously responsible for most epidemics, has fallen by 99% in vaccinated countries. Success must, however, not distract from the continuing ...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2017.1412022
更新日期:2018-05-04 00:00:00
abstract::Ebola virus disease (EVD) has become a great threat to humans across the world in recent years. The 2014 Ebola epidemic in West Africa caused numerous deaths and attracted worldwide attentions. Since no specific drugs and treatments against EVD was available, vaccination was considered as the most promising and effect...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2016.1225637
更新日期:2017-01-02 00:00:00
abstract::Hepatitis B virus (HBV) remains a challenging public-health issue in China. Hepatitis B carriers and patients suffer not only physically but also experience strong discrimination and stigma. China's rural population is 629 million. Thus, there is a great need to understand the situation surrounding HBV-related discrim...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2015.1069932
更新日期:2016-01-01 00:00:00
abstract::The Solid Organ Transplantation (SOT) and Haematopoietic Stem Cell Transplantation (HSCT) population is continuously increasing as a result of broader indications for transplant and improved survival. Infectious diseases, including vaccine-preventable diseases, are a significant threat for this population, primarily a...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.1080/21645515.2015.1078043
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:We studied completeness and timeliness of vaccination and determinants for low and delayed uptake in children born between 2008 and 2009 in Zhejiang province in eastern China. METHODS:We used data from a cross-sectional cluster survey conducted in 2011, which included 1146 children born from 1 Jan 2008 to 3...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.4161/hv.28054
更新日期:2014-01-01 00:00:00
abstract::In 1796, Edward Jenner introduced the concept of vaccination with cowpox virus, an Orthopoxvirus within the family Poxviridae that elicits cross protective immunity against related orthopoxviruses, including smallpox virus (variola virus). Over time, vaccinia virus (VACV) replaced cowpox virus as the smallpox vaccine,...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,评审
doi:10.4161/hv.21080
更新日期:2012-07-01 00:00:00
abstract::Within the past few years, several measles outbreaks have occurred in the southeast of Iran. To learn about the effectiveness of the immunization services for producing a serologic response against measles, this follow-up study was designed and implemented in the southeast of Iran. In Iran, all routine immunization se...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章
doi:10.1080/21645515.2016.1214346
更新日期:2016-12-01 00:00:00
abstract::Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 years of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Dru...
journal_title:Human vaccines & immunotherapeutics
pub_type: 杂志文章,随机对照试验
doi:10.4161/hv.19853
更新日期:2012-06-01 00:00:00