Abstract:
BACKGROUND:New, more effective vaccines to prevent tuberculosis (TB) disease are needed urgently. H4:IC31 is an investigational vaccine that contains a fusion protein of the immunodominant antigens TB10.4 and Ag85B, formulated in IC31 adjuvant. We assessed the safety and immunogenicity of H4:IC31 in South African adults from a TB endemic setting. METHODS:In this double blind, placebo controlled, phase I trial, Mycobacterium tuberculosis-uninfected, HIV-uninfected, healthy adults with a history of childhood BCG vaccination were randomly allocated to two intramuscular vaccinations with 5, 15, 50 or 150 μg H4 formulated in 500nmol IC31, two months apart. Vaccinees were followed for six months to assess safety; immunogenicity was measured by ELISpot and intracellular cytokine staining assays. RESULTS:Thirty-two participants received H4:IC31 and 8 received placebo. Injection site adverse events were common but mild; mild fatigue was the most common systemic adverse event. Frequencies of adverse events did not differ between dosage groups. Detectable antigen-specific CD4 T cell responses were induced by all doses of H4:IC31, but doses below 50 μg induced the highest frequencies of CD4 T cells, comprised predominantly of IFN-γ(+)TNF-α(+)IL-2(+) or TNF-α(+)IL-2(+) cells. These memory responses persisted up to the end of follow up, on study day 182. CONCLUSIONS:H4:IC31 demonstrated an acceptable safety profile and was immunogenic in South African adults. In this trial, the 15 μg dose appeared to induce the most optimal immune response.
journal_name
Vaccinejournal_title
Vaccineauthors
Geldenhuys H,Mearns H,Miles DJ,Tameris M,Hokey D,Shi Z,Bennett S,Andersen P,Kromann I,Hoff ST,Hanekom WA,Mahomed H,Hatherill M,Scriba TJ,H4:IC31 Trial Study Group.,van Rooyen M,Bruce McClain J,Ryall R,de Bruyn G,H4:doi
10.1016/j.vaccine.2015.05.036subject
Has Abstractpub_date
2015-07-09 00:00:00pages
3592-9issue
30eissn
0264-410Xissn
1873-2518pii
S0264-410X(15)00688-Xjournal_volume
33pub_type
杂志文章,随机对照试验相关文献
VACCINE文献大全abstract::Since the mid-1970s, the widespread establishment and implementation of the Expanded Programme on Immunization (EPI) has led to remarkable achievements in controlling vaccine preventable diseases worldwide. Today, more children than ever are being reached with immunization; interruption of poliomyelitis transmission h...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2012.01.080
更新日期:2011-12-30 00:00:00
abstract::Vaccination is considered the most cost-effective approach to preventing infectious diseases, yet better formulations and delivery methods for efficient distribution and administration of vaccines are needed, especially for low-resource settings. A fast-dissolving tablet (FDT) that could be packaged in a compact stack...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2013.08.010
更新日期:2013-10-01 00:00:00
abstract::This study assessed (1) T-cell responses following vaccination of HIV-1 negative volunteers with HIV-1LAI recombinant gp160 (rgp160) vaccine, and (2) effects of vaccine injection schedule and MHC HLA type on those responses. In one trial, volunteers received rgp160 in two accelerated schedules (Groups 1 and 2). In the...
journal_title:Vaccine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/0264-410x(95)00020-2
更新日期:1995-09-01 00:00:00
abstract:BACKGROUND:Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in infants. A conserved, surface-exposed lipoprotein, LP2086 (a factor H-binding protein [fHBP]), is a promising MnB vaccine target. A bivalent, recombinant vaccine targeting the fHBP (rLP2086) of MnB was developed. ...
journal_title:Vaccine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.vaccine.2014.07.049
更新日期:2014-09-08 00:00:00
abstract::A live Salmonella Enteritidis vaccine (SE147N ΔphoP fliC), able to express both a homologous intestinal colonisation-inhibition effect and a systemic invasion-inhibition effect, was tested for its potential to generate a postulated additive protective effect in case of combined application with a competitive exclusion...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.09.071
更新日期:2017-10-27 00:00:00
abstract::We recently identified a population of 10% of infants who respond with sub-protective antibody levels to most routine primary pediatric vaccinations due to altered innate and adaptive immune responses. We term these infants as low vaccine responders (LVRs). Here we report new data showing that TLR7/8 agonist - R848 st...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2016.09.050
更新日期:2016-11-11 00:00:00
abstract::In clinical trials recombinant-modified vaccinia virus Ankara expressing the Mycobacterium tuberculosis antigen 85A (MVA85A) induces approximately 10 times more effector T cells than any other recombinant MVA vaccine. We have found that in BCG primed subjects MVA85A vaccination reduces transforming growth factor beta ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2008.07.040
更新日期:2008-09-26 00:00:00
abstract::Equine influenza is a contagious diseases caused by equine influenza viruses which belong to the orthomyxovirus family. Outbreaks of equine influenza cause severe economic loses to the horse industry and consequently competition horses are required to be regularly vaccinated against equine influenza. Currently availab...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.06.085
更新日期:2009-09-04 00:00:00
abstract:BACKGROUND:Immunization of children with vaccines against Measles, Mumps, Rubella, and Varicella (MMRV) is practiced globally with varied recommendations. In India, measles vaccine is administered alone or as MMR at 9 months age. Varicella vaccine is not routinely used. Immunization age is a function of disappearance o...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2019.01.043
更新日期:2019-03-07 00:00:00
abstract:BACKGROUND:The hepatitis B surface antigen (HBsAg) has been administered over the last 20 years as a parenteral vaccine against the hepatitis B virus (HBV). Despite high seroconversion rates, chronic infection rates are still high worldwide. Orally delivered vaccines provide a practical alternative to injected vaccines...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2015.04.080
更新日期:2015-06-09 00:00:00
abstract::The immunological enhancement characteristics of the immunopotentiator CVC1302 were evaluated for foot-and-mouth disease virus (FMDV) inactivated vaccine in pigs. Eight-week-old piglets were vaccinated with the foot-and-mouth disease (FMD) vaccine alone (FMD-vaccine group) or with the addition of CVC1302 (FMD-CVC1302 ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2018.11.012
更新日期:2018-12-18 00:00:00
abstract:BACKGROUND:HIV-1 specific cellular immunity plays an important role in controlling viral replication. In this first-in-human therapeutic vaccination study, a replication-defective HIV-1 vaccine (HIVAX) was tested in HIV-1 infected participants undergoing highly active antiretroviral therapy (HAART) to enhance anti-HIV ...
journal_title:Vaccine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.vaccine.2016.03.021
更新日期:2016-04-27 00:00:00
abstract::The FML antigen of Leishmania donovani, in combination with either Riedel de Haën (R), QuilA, QS21 saponins, IL12 or BCG, was used in vaccination of an outbred murine model against visceral leishmaniasis (VL). Significant and specific increases in anti-FML IgG and IgM responses were detected for all adjuvants, and in ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(02)00444-9
更新日期:2002-11-22 00:00:00
abstract::This paper presents the results of a global survey that aimed to collect information on country's immunization policy development processes, particularly on the presence and function of national Immunization Technical Advisory Groups (ITAGs). Characteristics of national ITAGs are described as well as attributes of the...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.07.089
更新日期:2010-04-19 00:00:00
abstract::The objective of this study was to evaluate different preparations of avian metapneumovirus (aMPV) subtype C as vaccine challenge in turkeys. Two aMPV isolates and their respective nasal turbinate homogenates after propagation in turkeys were used in the study. Significantly higher clinical sign scores were recorded i...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2006.10.037
更新日期:2007-02-26 00:00:00
abstract::In 2010, the Brazilian Ministry of Health organized a mass vaccination campaign of selected priority groups in response to the 2009 H1N1 influenza pandemic. The campaign was conducted in six phases from March to July, 2010. Priority groups included healthcare professionals, indigenous persons, pregnant women, young ch...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2012.05.007
更新日期:2012-07-06 00:00:00
abstract::Treatment of cervical cancer greatly varies according to the stage of the disease. Laparoscopic surgical staging is emerging as a valid approach, compared to clinical and imaging staging, to better identify the treatment plan. Minimally invasive surgery plays the greatest role in the treatment of early cervical carcin...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2008.11.110
更新日期:2009-05-29 00:00:00
abstract::Epitopes in HIV polymerase were analyzed by peptide binding to human leukocyte antigen (HLA) A0201 molecules, the most frequent HLA class in the Caucasian population. We found that HIV-1 protease peptides representing both the wild type and anticipated drug resistance variants of the sequence bound well to HLA-A0201. ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2005.08.019
更新日期:2006-05-22 00:00:00
abstract::Rams which were vaccinated at 6-8 months of age with a water-in-oil Brucella ovis-vitamin E adjuvant vaccine had significantly higher serum antibody levels than rams vaccinated with a commercial B. ovis bacterin or B. melitensis Rev 1. The adjuvant vaccine did not cause abscesses at the site of injection as some water...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/0264-410x(91)90111-i
更新日期:1991-04-01 00:00:00
abstract::Peptides representing epitopes of the measles virus glycoproteins have been designed to induce neutralizing and protective antibodies. Those that escape recognition by passively acquired anti-whole virus antibodies could potentially be used as components of a 'pre-vaccine' that could be given during early childhood ir...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/s0264-410x(00)00452-7
更新日期:2001-03-21 00:00:00
abstract::Household surveys are frequently used as means of vaccination coverage measurement, but obtaining accurate survey estimates present several challenges. In 2015, the World Health Organization (WHO) released a working draft of its updated Vaccination Coverage Survey Reference Manual that moved well beyond the traditiona...
journal_title:Vaccine
pub_type:
doi:10.1016/j.vaccine.2018.07.019
更新日期:2018-08-16 00:00:00
abstract::This study examined the effect of congestive heart failure (CHF) on immune responses to influenza vaccination (2000-2001 preparation) in three groups of older adults including healthy, Class II and Class III/IV CHF. Serum antibody titers measured by hemagglutination inhibition (HI), and interferon-gamma (IFN-gamma), i...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2003.08.032
更新日期:2004-01-26 00:00:00
abstract::Hepatitis E virus (HEV) is a major cause of enterically transmitted acute hepatitis of adults in developing nations. Our present studies show that, the complete ORF2 gene (1-660 amino acids, a.a.) coding for capsid protein of HEV as candidate DNA vaccine induced significant specific humoral and cellular immune respons...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2007.03.040
更新日期:2007-05-30 00:00:00
abstract::A recombinant Lactobacillus casei expressing a flagellar antigen from Salmonella enterica serovar Enteritidis was constructed and evaluated as a mucosal vaccine. Intragastric immunization of the recombinant strain conferred protective immunity against Salmonella infection in mice. This immunization did not result in a...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2007.01.055
更新日期:2007-05-04 00:00:00
abstract:BACKGROUND:Combination antiretroviral therapy (cART) is the main therapeutic management tool for HIV/AIDS. Despite its success in controlling viral load and disease progression, cART is expensive, associated with a range of significant side effects and depends for its efficacy on the patient's life-long commitment to h...
journal_title:Vaccine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.vaccine.2013.09.057
更新日期:2013-11-19 00:00:00
abstract::Rift Valley fever (RVF) is a mosquito-borne zoonotic disease endemic to Africa and the Arabian Peninsula that affects sheep, cattle, goats, camels, and humans. Effective vaccination of susceptible ruminants is important for the prevention of RVF outbreaks. Live-attenuated RVF vaccines are in general highly immunogenic...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.10.036
更新日期:2017-12-04 00:00:00
abstract::The Indian rhesus macaque is the established animal model for HIV infection and vaccine research. Growing evidence suggests that the more readily available Chinese rhesus macaque may be a more relevant option. As increasing numbers of novel Chinese rhesus MHC alleles are reported, we decided to explore potential HIV v...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.12.117
更新日期:2012-02-21 00:00:00
abstract:BACKGROUND:Surveillance data on invasive pneumococcal disease (IPD) in Denmark (1999-2014) was analysed regarding the incidence and age-distribution due to ten selected non-PCV serotypes (10-Non-PCV). The effect of PCV-7 and PCV-13 vaccines on the 10-Non-PCV IPD incidence was examined. METHODS:IPD cases caused by sero...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2015.12.056
更新日期:2016-02-03 00:00:00
abstract::The characterization of the cross-reactive, or heterologous, neutralizing antibody (NAb) responses developed during HIV-1-infection is relevant to the development of an HIV vaccine. Here we summarize our recently published study where we characterized the cross-reactive NAb responses in two cohorts of anti-retroviral ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.07.085
更新日期:2010-05-26 00:00:00
abstract::Since 1999, Italy has been challenged by several epidemics of Notifiable Avian Influenza (NAI) of the H5 and H7 subtypes, occurring in the densely populated poultry areas of northern part of the country. Vaccination with a conventional vaccine containing a seed strain with a different neuraminidase subtype to the fiel...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2007.01.113
更新日期:2007-06-28 00:00:00