Evaluation of the safety, reactogenicity and immunogenicity of three recombinant outer surface protein (OspA) lyme vaccines in healthy adults.

Abstract:

:The safety, reactogenicity and immunogenicity of three candidate Lyme vaccines based on recombinant outer surface protein (OspA) presented in either lipidated or unlipidated forms, were assessed in 300 seronegative volunteers. Subjects received three doses of one of the three formulations at monthly intervals and were evaluated for antibody levels and the presence of symptoms after each dose. All formulations proved to be safe, the majority of local reactions being reported as mild, and all general symptoms were perceived to be either-mild or moderate in intensity. No subject refused a subsequent vaccine dose. All subjects were tested for both anti-OspA IgG and LA-2 equivalent antibodies up until day 84. All three vaccines induced an immune response but subjects who received lipoprotein OspA had the highest anti-OspA IgG and LA-2 equivalent GMTs after each dose and this was also true for the subset of subjects tested on day 180. The lipoprotein OspA group also had the largest number of subjects who remained seropositive for anti-OspA IgG antibodies. As the lipoprotein formulation produced the strongest immune response, with symptoms which were acceptable to all the vaccinees, we suggest further development of this vaccine.

journal_name

Vaccine

journal_title

Vaccine

authors

Van Hoecke C,Comberbach M,De Grave D,Desmons P,Fu D,Hauser P,Lebacq E,Lobet Y,Voet P

doi

10.1016/s0264-410x(96)00146-6

subject

Has Abstract

pub_date

1996-12-01 00:00:00

pages

1620-6

issue

17-18

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(96)00146-6

journal_volume

14

pub_type

临床试验,杂志文章,随机对照试验

相关文献

VACCINE文献大全
  • Future approaches to vaccine development: single-dose vaccines using controlled-release delivery systems.

    abstract::The development of single-dose vaccines, mainly those administered during childhood, which would effectively protect against certain diseases, would be a very important advance towards better immunization coverage and protection against the respective pathogens. Biodegradable polymeric microspheres which are 'programm...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/0264-410x(93)90241-o

    authors: Aguado MT

    更新日期:1993-01-01 00:00:00

  • Biocompatible cationic solid lipid nanoparticles as adjuvants effectively improve humoral and T cell immune response of foot and mouth disease vaccines.

    abstract::In this work, we explored the potential of cationic solid lipid nanoparticles (cSLN) as efficient adjuvants for inactivated foot and mouth disease virus (iFMDV) vaccine. The cSLN were prepared by O/W emulsion method with Compritol 888 ATO as lipid matrix, and were modified by cationic lipid Didodecyldimethylammonium b...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2020.02.004

    authors: Li S,Yang Y,Lin X,Li Z,Ma G,Su Z,Zhang S

    更新日期:2020-03-04 00:00:00

  • Factors associated with uptake of vaccination against pandemic influenza: a systematic review.

    abstract:BACKGROUND:In June 2009 a global influenza pandemic was declared by the World Health Organisation. A vaccination programme against H1N1 influenza was introduced in many countries from September 2009, but there was low uptake in both the general population and health professionals in many, though not all, countries. PU...

    journal_title:Vaccine

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.vaccine.2011.06.107

    authors: Bish A,Yardley L,Nicoll A,Michie S

    更新日期:2011-09-02 00:00:00

  • A therapeutic HIV-1 vaccine enhances anti-HIV-1 immune responses in patients under highly active antiretroviral therapy.

    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

    authors: Tung FY,Tung JK,Pallikkuth S,Pahwa S,Fischl MA

    更新日期:2016-04-27 00:00:00

  • The feasibility of identifying children with primary immunodeficiency disorders: preparation for the polio post-eradication era in Bangladesh.

    abstract:BACKGROUND:Persons with primary immunodeficiency disorders (PIDD) who receive oral poliovirus vaccine (OPV) or are household contacts of OPV recipients are at risk of excreting immunodeficiency-associated vaccine-derived polioviruses (iVDPVs). iVDPVs can be transmitted and cause paralytic polio. The objective of this s...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2012.06.017

    authors: Sazzad HM,Rainey JJ,Mach O,Sutter R,Diordista S,Kawser CA,Mobarak R,Alam D,Chowdhury MA,Hossain MJ,Hasan AS,Luby SP

    更新日期:2012-08-03 00:00:00

  • Envelope proteins of two HIV-1 clades induced different epitope-specific antibody response.

    abstract::Using HIV-1 envelope protein (Env)-based immunogens that closely mimic the conformation of functional HIV-1 Envs and represent the isolates prevalent in relevant geographical region is considered a rational approach towards developing HIV vaccine. We recently reported that like clade B Env, JRFL, membrane bound Indian...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2018.01.081

    authors: Shrivastava T,Samal S,Tyagi AK,Goswami S,Kumar N,Ozorowski G,Ward AB,Chakrabarti BK

    更新日期:2018-03-14 00:00:00

  • U.K. parents' decision-making about measles-mumps-rubella (MMR) vaccine 10 years after the MMR-autism controversy: a qualitative analysis.

    abstract:BACKGROUND AND OBJECTIVES:Public concern about an unsubstantiated link between MMR vaccine and autism stemmed from a 1998 paper by Dr Andrew Wakefield and colleagues, and the substantial media coverage which that work attracted. Though the Wakefield paper is now discredited and an MMR-autism link has never been demonst...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2011.12.127

    authors: Brown KF,Long SJ,Ramsay M,Hudson MJ,Green J,Vincent CA,Kroll JS,Fraser G,Sevdalis N

    更新日期:2012-02-27 00:00:00

  • A humanized monoclonal antibody targeting Staphylococcus aureus.

    abstract::This current presentation describes the in vitro and in vivo characterization of Aurexis (tefibazumab), a humanized monoclonal antibody that exhibits a high affinity and specificity and for the Staphylococcus aureus MSCRAMM (Microbial Surface Components Recognizing Adhesive Matrix Molecules) protein ClfA. Aurexis inhi...

    journal_title:Vaccine

    pub_type: 杂志文章,评审

    doi:10.1016/j.vaccine.2004.08.015

    authors: Patti JM

    更新日期:2004-12-06 00:00:00

  • SIV vaccines: current status. The role of the SIV-macaque model in AIDS research.

    abstract::SIV vaccines made of inactivated whole virus, modified live virus and native and recombinant envelope antigens have protected macaques against experimental infection with low doses of cell-free SIV given systemically. The few vaccinated monkeys that do become infected have tended to live longer than the infected contr...

    journal_title:Vaccine

    pub_type: 杂志文章,评审

    doi:10.1016/0264-410x(91)90213-p

    authors: Gardner M

    更新日期:1991-11-01 00:00:00

  • Enhancement of the protective effect of inactivated influenza virus vaccine by cytokines.

    abstract::The authors examined whether or not cytokines in conjunction with inactivated influenza virus vaccine enhance protection from influenza virus infection in mice. Mice were infected with influenza virus A/PR/8/34 (PR/8) at 10 LD50 by nebulizer after intranasal administration of the cytokine and the vaccine. The survival...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/0264-410x(92)90158-g

    authors: Cao M,Sasaki O,Yamada A,Imanishi J

    更新日期:1992-01-01 00:00:00

  • In vitro culture medium influences the vaccine efficacy of Mycobacterium bovis BCG.

    abstract::The varied rates of protection induced by Mycobacterium bovis BCG vaccine against tuberculosis has been attributed to many factors such as genetic variability among BCG strains, rapid clearance of BCG in some populations, and different levels of previous exposure of vaccinated populations to environmental mycobacteria...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2011.12.044

    authors: Venkataswamy MM,Goldberg MF,Baena A,Chan J,Jacobs WR Jr,Porcelli SA

    更新日期:2012-02-01 00:00:00

  • Leishmania major heat shock protein 70 (HSP70) is not protective in murine models of cutaneous leishmaniasis and stimulates strong humoral responses in cutaneous and visceral leishmaniasis patients.

    abstract::Heat shock proteins (HSP) are highly conserved molecules that play important roles in protein folding, assembly of protein complexes and translocation of proteins across cellular compartments, as well as in several immunological processes. In this study, we first immunized susceptible BALB/c and resistant C57BL/6 mice...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2007.03.006

    authors: Rafati S,Gholami E,Hassani N,Ghaemimanesh F,Taslimi Y,Taheri T,Soong L

    更新日期:2007-05-22 00:00:00

  • Immunogenicity of an alum-adsorbed synthetic multiple-antigen peptide based on B- and T-cell epitopes of the Plasmodium falciparum CS protein: possible vaccine application.

    abstract::Multiple-antigen peptides (MAPs), containing B- and T-cell epitopes of the Plasmodium falciparum circumsporozoite (CS) protein, have been designed to overcome the limitations of first-generation peptide vaccines caused by low epitope density, carrier toxicity and the lack of parasite-derived T-cell epitopes. The immun...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/0264-410x(94)90337-9

    authors: de Oliveira GA,Clavijo P,Nussenzweig RS,Nardin EH

    更新日期:1994-08-01 00:00:00

  • The adjuvant CLDC increases protection of a herpes simplex type 2 glycoprotein D vaccine in guinea pigs.

    abstract::Herpes simplex virus (HSV) infections are common but there is no vaccine available. We evaluated cationic liposome-DNA complexes (CLDC) as an adjuvant for an HSV gD2 vaccine and compared it to an MPL/Alum adjuvant in a guinea pig model of genital herpes. The addition of CLDC to the gD2 vaccine significantly decreased ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2009.10.025

    authors: Bernstein DI,Farley N,Bravo FJ,Earwood J,McNeal M,Fairman J,Cardin R

    更新日期:2010-05-07 00:00:00

  • Immunogenicity of porcine P[6], P[7]-specific △VP8* rotavirus subunit vaccines with a tetanus toxoid universal T cell epitope.

    abstract::Currently, commercial porcine rotavirus vaccines remain varied limitations. The objective of this study is to develop an alternative porcine rotavirus subunit vaccine candidate by parenteral administration, which enables to elicit robust immune responses against most prevalence porcine rotavirus strains. The bacterial...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2015.07.011

    authors: Wen X,Wei X,Ran X,Ni H,Cao S,Zhang Y

    更新日期:2015-08-26 00:00:00

  • Comparative incidence dynamics and serotypes of meningitis, bacteremic pneumonia and other-IPD in young children in the PCV era: Insights from Israeli surveillance studies.

    abstract:INTRODUCTION:Widespread introduction of pneumococcal conjugated vaccines (PCVs) impacted on invasive pneumococcal disease (IPD). However, IPD reduction may not be similar in all outcomes within IPD. We assessed PCV7/PCV13 impact on pneumococcal meningitis, bacteremic pneumonia (BP) and other (non-meningitis, non-pneumo...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2017.05.059

    authors: Ben-Shimol S,Givon-Lavi N,Grisaru-Soen G,Megged O,Greenberg D,Dagan R,Israel Bacteremia and Meningitis Active Surveillance Group.

    更新日期:2018-08-28 00:00:00

  • Risk of solid organ transplant rejection following vaccination with seasonal trivalent inactivated influenza vaccines in England: A self-controlled case-series.

    abstract:BACKGROUND:Annual seasonal influenza vaccination is recommended for transplant recipients. No formal pharmacoepidemiology study has been published on the association between solid organ transplant (SOT) rejection and vaccination with seasonal trivalent inactivated influenza vaccines (TIIVs). METHODS:The risk of SOT (l...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2016.05.016

    authors: Dos Santos G,Haguinet F,Cohet C,Webb D,Logie J,Ferreira GL,Rosillon D,Shinde V

    更新日期:2016-06-30 00:00:00

  • The first experimental study on a candidate combined vaccine against hepatitis A and hepatitis E.

    abstract::To test the possibility of developing a combined vaccine against hepatitis A and E, groups of mice were immunized with different formulations containing different dosages of a commercially inactivated hepatitis A vaccine and a candidate recombinant hepatitis E vaccine. Monovalent vaccine components were used as contro...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2006.11.001

    authors: Dong C,Dai X,Meng JH

    更新日期:2007-02-19 00:00:00

  • Estimating the effect of measles vaccination on child growth using 191 DHS from 65 low- and middle-income countries.

    abstract:BACKGROUND:Childhood vaccinations reduce morbidity and mortality and are highly cost-effective. They may also protect children from malnutrition and lead to improved child growth. Stunting, wasting and underweight are targets used to monitor progress towards the achievement of the sustainable development goals (SDGs). ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2019.06.054

    authors: Bogler L,Jantos N,Bärnighausen T,Vollmer S

    更新日期:2019-08-14 00:00:00

  • Risk factors for measles in children aged 8 months-14 years in China after nationwide measles campaign: A multi-site case-control study, 2012-2013.

    abstract:INTRODUCTION:Endemic measles persists in China, despite >95% reported coverage of two measles-containing vaccine doses and nationwide campaign that vaccinated more than 100 million children in 2010. In 2011, almost half of the 9943 measles cases in China occurred in children eligible for measles vaccination. We conduct...

    journal_title:Vaccine

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.vaccine.2016.02.005

    authors: Hao L,Ma C,Wannemuehler KA,Su Q,An Z,Cairns L,Quick L,Rodewald L,Liu Y,He H,Xu Q,Ma Y,Yu W,Zhang N,Li L,Wang N,Luo H,Wang H,Gregory CJ

    更新日期:2016-12-12 00:00:00

  • Beliefs around childhood vaccines in the United States: A systematic review.

    abstract:BACKGROUND:While childhood vaccines are safe and effective, some parents remain hesitant to vaccinate their children, which has led to outbreaks of vaccine preventable diseases. The goal of this systematic review was to identify and summarize the range of beliefs around childhood vaccines elicited using open-ended ques...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2019.08.068

    authors: Gidengil C,Chen C,Parker AM,Nowak S,Matthews L

    更新日期:2019-10-23 00:00:00

  • Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps.

    abstract:BACKGROUND:In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and loca...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2020.08.077

    authors: van der Graaf R,Macklin R,Rid A,Bhan A,Gefenas E,Greco D,Haerry D,Hurst S,London AJ,Saracci R,Sprumont D,van Delden JJM

    更新日期:2020-10-21 00:00:00

  • Proximity to safety-net clinics and HPV vaccine uptake among low-income, ethnic minority girls.

    abstract:PURPOSE:Human Papillomavirus (HPV) vaccine uptake remains low. Although publicly funded programs provide free or low cost vaccines to low-income children, barriers aside from cost may prevent disadvantaged girls from getting vaccinated. Prior studies have shown distance to health care as a potential barrier to utilizin...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2013.02.046

    authors: Tsui J,Singhal R,Rodriguez HP,Gee GC,Glenn BA,Bastani R

    更新日期:2013-04-12 00:00:00

  • Enhanced cellular immune responses to SIV Gag by immunization with influenza and vaccinia virus recombinants.

    abstract::An effective vaccination strategy against human immunodeficiency virus type 1 (HIV-1) should include the induction of potent cellular immune responses against conserved HIV-1 antigens. We have generated five replication competent recombinant influenza viruses (rFlu/SIV Gag nos. 1-5) expressing different portions of Ga...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(02)00781-8

    authors: Nakaya Y,Zheng H,García-Sastre A

    更新日期:2003-05-16 00:00:00

  • Placebo-controlled efficacy study of hepatitis A vaccine in Valdivia, Chile.

    abstract::A placebo-controlled, double-blind study on the efficacy of a hepatitis A vaccine (SmithKline Beecham Biologicals) was started in a region of Chile in September 1990, using hepatitis B vaccine as control. A total of 260 healthy children, 6-15 years of age, negative for antibody to hepatitis A virus (anti-HAV), antibod...

    journal_title:Vaccine

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/0264-410x(92)90573-3

    authors: Riedemann S,Reinhardt G,Frösner GG,Ibarra H,Moraleda L,Hering V,Siegel F,Toledo C,Leon J,Gonzalez JL

    更新日期:1992-01-01 00:00:00

  • Phase 1 testing of detoxified LPS/group B meningococcal outer membrane protein vaccine with and without synthetic CPG 7909 adjuvant for the prevention and treatment of sepsis.

    abstract:BACKGROUND:Gram-negative bacteria (GNB) are a leading cause of nosocomial infection and sepsis. Increasing multi-antibiotic resistance has left clinicians with fewer therapeutic options. Antibodies to GNB lipopolysaccharide (LPS, or endotoxin) have reduced morbidity and mortality as a result of infection and are not su...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2015.10.072

    authors: Cross AS,Greenberg N,Billington M,Zhang L,DeFilippi C,May RC,Bajwa KK

    更新日期:2015-11-27 00:00:00

  • Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation.

    abstract::ADVAX is a DNA-based candidate HIV vaccine that was safe but weakly immunogenic when delivered intramuscularly (IM) in humans. Studies were performed in animal models to determine whether an alternative delivery method, in vivo electroporation (EP), could improve the immunogenicity of ADVAX while maintaining an accept...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2010.11.011

    authors: Dolter KE,Evans CF,Ellefsen B,Song J,Boente-Carrera M,Vittorino R,Rosenberg TJ,Hannaman D,Vasan S

    更新日期:2011-01-17 00:00:00

  • Impact of the National Perinatal Hepatitis B Prevention Programme in the Republic of Korea: A retrospective registry-based cohort study.

    abstract:INTRODUCTION:Hepatitis B is a major preventable cause of morbidity and mortality from chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. We aimed to evaluate the performance and outcomes of the Korean Perinatal Hepatitis B Prevention Programme (PHBPP) and to investigate the impact of the current post-exp...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2020.05.044

    authors: Yang TU,Jung CW,Kim D,Park HA,Jee Y

    更新日期:2020-07-22 00:00:00

  • Comparison of eight Lactobacillus species for delivery of surface-displayed mycobacterial antigen.

    abstract::Lactobacillus spp. comprise a large group of Gram-positive lactic acid bacteria with varying physiological, ecological and immunomodulatory properties that are widely exploited by mankind, primarily in food production and as health-promoting probiotics. Recent years have shown increased interest in using lactobacilli ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2019.09.012

    authors: Kuczkowska K,Øverland L,Rocha SDC,Eijsink VGH,Mathiesen G

    更新日期:2019-10-08 00:00:00

  • Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults.

    abstract::Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerat...

    journal_title:Vaccine

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.vaccine.2007.04.008

    authors: Moutschen M,Léonard P,Sokal EM,Smets F,Haumont M,Mazzu P,Bollen A,Denamur F,Peeters P,Dubin G,Denis M

    更新日期:2007-06-11 00:00:00