Rationale and design of a community-based double-blind randomized clinical trial of an HPV 16 and 18 vaccine in Guanacaste, Costa Rica.

Abstract:

:We report the rationale, design, methods and details of participation of a community-based, double-blind, randomized clinical trial of an HPV 16 and 18 vaccine conducted in two provinces of Costa Rica to investigate the efficacy and population impact of the vaccine in the prevention of cervical cancer precursors. More than 24,000 women between 18 and 25 years of age were invited to participate and pre-screened for eligibility, with recruitment of 7466 women (30% of those pre-screened, 59% of those eligible) who were randomized to receive 3 doses of the HPV vaccine or hepatitis A vaccine as control. A complex protocol of data and specimen collection was applied, including an interview, pelvic exam for sexually active women, blood for serology and cell-mediated immunity, cervical secretions for local immunity and cells for HPV, Chlamydia trachomatis and gonorrhea testing. Eighty percent of the women received three doses, 12.4% two doses and 7.4% one dose. At visits, compliance with data and specimen collection was close to 100%. Baseline characteristics and age-specific prevalence of HPV and cervical neoplasia are reported. Overall prevalence of HPV was high (50%), with 8.3% of women having HPV 16 and 3.2% HPV 18. LSIL was detected in 12.7% of women at baseline and HSIL in 1.9%. Prevalence of Chlamydia was 14.2%. There was very good agreement in HPV detection between clinician-collected and self- collected specimens (89.4% agreement for all types, kappa 0.59). Follow up will continue with yearly or more frequent examinations for at least 4 years for each participant.

journal_name

Vaccine

journal_title

Vaccine

authors

Herrero R,Hildesheim A,Rodríguez AC,Wacholder S,Bratti C,Solomon D,González P,Porras C,Jiménez S,Guillen D,Morales J,Alfaro M,Cyr J,Morrisey K,Estrada Y,Cortés B,Morera LA,Freer E,Schussler J,Schiller J,Lowy D,S

doi

10.1016/j.vaccine.2008.07.002

subject

Has Abstract

pub_date

2008-09-02 00:00:00

pages

4795-808

issue

37

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(08)00865-7

journal_volume

26

pub_type

杂志文章,随机对照试验

相关文献

VACCINE文献大全
  • A recombinant vaccinia-rabies virus in the immunocompromised host: oral innocuity, progressive parenteral infection, and therapeutics.

    abstract::With the emergence of raccoons (Procyon lotor) as the primary rabies reservoir in the United States of America, a recombinant vaccinia-rabies glycoprotein (V-RG) virus vaccine was developed that protected raccoons by the oral route from rabies infection. Despite extensive laboratory evaluation, vaccine safety concerns...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(96)00163-6

    authors: Hanlon CA,Niezgoda M,Shankar V,Niu HS,Koprowski H,Rupprecht CE

    更新日期:1997-02-01 00:00:00

  • Delayed progression of murine AIDS in C57BL/6 mice pre-immunized with a highly antigenic 10-mer peptide encoded by the murine AIDS defective virus gag p12 gene.

    abstract::C57BL/6 (B6) mice were immunized with a highly antigenic 10-mer peptide (P12-10), which is encoded by the murine AIDS (MAIDS) defective virus gag p12 gene, emulsified in incomplete Freund's adjuvant (ICFA). One week later, the mice were inoculated with the MAIDS virus to see if the immunization affects progression of ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(98)00082-6

    authors: Mizuochi T,Horino A,Uchida T

    更新日期:1998-12-01 00:00:00

  • Prothymosin alpha enhances protective immune responses induced by oral DNA vaccination against pseudorabies delivered by Salmonella choleraesuis.

    abstract::Previously, we showed that vaccination with the glycoprotein D (gD) gene of pseudorabies virus (PrV) delivered by Escherichia coli induced protective immune responses. In this study, we report that oral DNA vaccination with attenuated Salmonella choleraesuis carrying the PrV gD gene conferred protective immunity in mi...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(01)00130-x

    authors: Shiau AL,Chen YL,Liao CY,Huang YS,Wu CL

    更新日期:2001-07-16 00:00:00

  • Influenza vaccination coverage in adults belonging to defined target groups, Germany, 2003/2004.

    abstract::In 2003, a nationwide cross-sectional study was conducted to assess the current influenza vaccination coverage of the adult population of Germany, especially in persons belonging to defined target groups. Of 666 surveyed persons, 190 (adjusted 24%) had received influenza vaccination and 419 participants belonged to at...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2005.12.020

    authors: Wiese-Posselt M,Leitmeyer K,Hamouda O,Bocter N,Zöllner I,Haas W,Ammon A

    更新日期:2006-03-24 00:00:00

  • Modeling cervical cancer prevention in developed countries.

    abstract::Cytology-based screening has reduced cervical cancer mortality in countries able to implement, sustain and financially support organized programs that achieve broad coverage. These ongoing secondary prevention efforts considerably complicate the question of whether vaccination against human papillomavirus (HPV) types ...

    journal_title:Vaccine

    pub_type: 杂志文章,评审

    doi:10.1016/j.vaccine.2008.06.009

    authors: Kim JJ,Brisson M,Edmunds WJ,Goldie SJ

    更新日期:2008-08-19 00:00:00

  • No evidence of cross-reactivity of human antibodies to a 33-mer peptide of the alpha-gliadin component of gluten with Bordetella pertussis pertactin.

    abstract::A 33-mer peptide of the alpha-gliadin component of gluten was recently identified as primary initiator of the inflammatory response to gluten in coeliac disease (CD) patients. This proline-glutamine-rich peptide (PG-peptide) is highly homologous to internal sequence of pertactin, an immunogenic protein of Bordetella p...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2005.01.078

    authors: He Q,Viljanen MK,Hinkkanen AE,Arvilommi H,Mertsola J,Viander M

    更新日期:2005-05-09 00:00:00

  • Development and evaluation of live attenuated Salmonella vaccines in newly hatched duckings.

    abstract::Domestic ducks remain a major source of zoonotic Salmonella enterica infections for man worldwide and approaches to protection should include vaccine-mediated immunity. With this in mind we developed several genetically defined mutants in a virulent duck Salmonella typhimurium isolate TT-1. From initial tests for viru...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2015.09.004

    authors: Tang T,Gao Q,Barrow P,Wang M,Cheng A,Jia R,Zhu D,Chen S,Liu M,Sun K,Yang Q,Chen X

    更新日期:2015-10-13 00:00:00

  • Artesunate enhances the immune response of rabies vaccine as an adjuvant.

    abstract::Rabies is an ancient zoonosis that continues to be an important health problem worldwide. Vaccination with rabies vaccine is the most important strategy to prevent rabies. Adjuvants contribute to the immune response of viral vaccine. The aim of this study was to investigate whether artemisinin derivatives artesunate a...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2019.09.077

    authors: Luo J,Zhang Y,He H,Liu Q,Huang S,Guo X

    更新日期:2019-12-03 00:00:00

  • The choice of analytical methodology can alter conclusions regarding herd effects of paediatric pneumococcal vaccination programmes.

    abstract:BACKGROUND:Estimation of the magnitude of the herd effect on invasive pneumococcal disease (IPD) is important when evaluating health benefits and cost-effectiveness of paediatric pneumococcal conjugate vaccine (PCV) programmes and may influence policy makers' decisions on PCV use. Several epidemiological, programmatic,...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2018.10.003

    authors: Pirçon JY,Talarico CA,Bollaerts K,Hausdorff WP,Clarke CJ

    更新日期:2018-11-12 00:00:00

  • A population-based study on tetanus antitoxin levels in The Netherlands.

    abstract::We assessed the tetanus immunity of the general Dutch population and of religious groups refusing vaccination by means of population-based study to evaluate the effect of tetanus vaccination. More than 95% of those born after the introduction of routine vaccination had tetanus antitoxin levels above the minimum protec...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(99)00186-3

    authors: de Melker HE,van den Hof S,Berbers GA,Nagelkerke NJ,Rümke HC,Conyn-van Spaendonck MA

    更新日期:1999-08-20 00:00:00

  • Is varicella vaccination associated with pediatric arterial ischemic stroke? A population-based cohort study.

    abstract:BACKGROUND AND PURPOSE:Varicella disease is a risk factor for pediatric Arterial Ischemic Stroke (AIS). Isolated case reports have emerged suggesting that varicella vaccination may also pose a risk for AIS. METHODS:This retrospective population-based cohort study assessed the risk of AIS in children who received a var...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2018.04.012

    authors: MacDonald SE,Dover DC,Hill MD,Kirton A,Simmonds KA,Svenson LW

    更新日期:2018-05-11 00:00:00

  • Long-term persistence of tick-borne encephalitis antibodies in adults 5 years after booster vaccination with Encepur Adults.

    abstract::Tick-borne encephalitis (TBE) is a potentially serious disease, especially in adults. There is no treatment available for TBE; supportive therapy may help to ease symptoms of the disease. Vaccination is the most effective method of preventing TBE disease and is recommended for those who live, work, or travel in TBE-en...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2008.11.082

    authors: Plentz A,Jilg W,Schwarz TF,Kuhr HB,Zent O

    更新日期:2009-02-05 00:00:00

  • Using pCIN-mIL-4 DNA vector to express mRNA and protein and to improve herpes simplex virus-induced Behcet's disease symptoms in mice.

    abstract::Behcet's disease (BD) is a chronic, recurrent, inflammatory, multisystemic disorder characterized primarily by vasculitis. The etiopathogenesis of BD involves immunogenetics, infectious organisms (streptococcus, herpes simplex virus), immunoregulation and vascular dysfunctions. We previously found that immunoregulatio...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2007.07.062

    authors: Lee SI,Kwon HJ,Lee ES,Yang BC,Bang D,Lee S,Sohn S

    更新日期:2007-10-10 00:00:00

  • Comparison of adjuvants to optimize influenza neutralizing antibody responses.

    abstract::Seasonal influenza vaccines represent a positive intervention to limit the spread of the virus and protect public health. Yet continual influenza evolution and its ability to evade immunity pose a constant threat. For these reasons, vaccines with improved potency and breadth of protection remain an important need. We ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2019.08.030

    authors: Rudicell RS,Garinot M,Kanekiyo M,Kamp HD,Swanson K,Chou TH,Dai S,Bedel O,Simard D,Gillespie RA,Yang K,Reardon M,Avila LZ,Besev M,Dhal PK,Dharanipragada R,Zheng L,Duan X,Dinapoli J,Vogel TU,Kleanthous H,Mascola J

    更新日期:2019-09-30 00:00:00

  • Immunisation with a plasmid DNA vaccine encoding gonadotrophin releasing hormone (GnRH-I) and T-helper epitopes in saline suppresses rodent fertility.

    abstract::Research into active immunisation against gonadotrophin releasing hormone (GnRH-I) has gained widespread acceptance as a means of controlling reproduction and behaviour of farm, companion and wild animals. Many studies describe the use of multiple copies of the self-peptide in linear alignment and conjugation with a l...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2007.12.052

    authors: Khan MA,Ogita K,Ferro VA,Kumasawa K,Tsutsui T,Kimura T

    更新日期:2008-03-04 00:00:00

  • Monitoring the process of measles elimination by serosurveillance data: The Apulian 2012 study.

    abstract::In 2003 Italy adopted the National Plan for Measles and Congenital Rubella Elimination, but some outbreaks of measles are still occurring, as the target coverage rate (≥ 95%) for new-borns has currently not been achieved. In order to support the monitoring of the measles elimination programme, the authors carried out ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2016.03.011

    authors: Tafuri S,Gallone MS,Gallone MF,Pappagallo MT,Larocca A,Germinario C

    更新日期:2016-04-19 00:00:00

  • WITHDRAWN: Impact of the Hajj on pneumococcal carriage and the effect of various pneumococcal vaccines.

    abstract::This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at https://www.elsevier.com/about/our-business/policies/article-withdrawal. ...

    journal_title:Vaccine

    pub_type: 撤回出版物

    doi:10.1016/j.vaccine.2017.03.109

    authors: Edouard S,Al-Tawfiq JA,Memish ZA,Yezli S,Gautret P

    更新日期:2017-08-07 00:00:00

  • Effectiveness of HPV vaccination against high grade cervical lesions in Japan.

    abstract::The effectiveness of HPV vaccine against HSIL+ (pathologically diagnosed CIN2+) in the first cohort in Japan was investigated in 22,743 women aged 20 to 29 years (parts of national cervical cancer screening program of FY [fiscal year] 2015, the Japan Cancer Society). Vaccinated women had a statistically significant 69...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2018.05.048

    authors: Konno R,Konishi H,Sauvaget C,Ohashi Y,Kakizoe T

    更新日期:2018-12-18 00:00:00

  • Effect of different adjuvant formulations on the immunogenicity and protective effect of a live Mycoplasma hyopneumoniae vaccine after intramuscular inoculation.

    abstract::Mycoplasma hyopneumoniae (M. hyopneumoniae) vaccine strain 168 is an intrapulmonically injected attenuated live vaccine that is available in the Chinese market. The aim of this study was to develop suitable adjuvants for this live vaccine to provide effective protection after intramuscular inoculation. Several adjuvan...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2014.03.071

    authors: Xiong Q,Wei Y,Xie H,Feng Z,Gan Y,Wang C,Liu M,Bai F,Xie F,Shao G

    更新日期:2014-06-05 00:00:00

  • Poor knowledge of vaccination recommendations and negative attitudes towards vaccinations are independently associated with poor vaccination uptake among adults - Findings of a population-based panel study in Lower Saxony, Germany.

    abstract:OBJECTIVES:The aims of this study were to (a) assess knowledge of official vaccination recommendations and attitudes towards vaccinations among adults and (b) examine their association with vaccination uptake among adults. METHODS:This study was part of the HaBIDS study (Hygiene and Behaviour Infectious Diseases Surve...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2018.03.050

    authors: Akmatov MK,Rübsamen N,Deyneko IV,Karch A,Mikolajczyk RT

    更新日期:2018-04-25 00:00:00

  • Characterization of size, structure and purity of serogroup X Neisseria meningitidis polysaccharide, and development of an assay for quantification of human antibodies.

    abstract::Serogroup X Neisseria meningitidis (MenX) has recently emerged as a cause of localized disease outbreaks in sub-Saharan Africa. In order to prepare for vaccine development, MenX polysaccharide (MenX PS) was purified by standard methods and analyzed for identity and structure by NMR spectroscopy. This study presents th...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2012.07.032

    authors: Xie O,Bolgiano B,Gao F,Lockyer K,Swann C,Jones C,Delrieu I,Njanpop-Lafourcade BM,Tamekloe TA,Pollard AJ,Norheim G

    更新日期:2012-08-31 00:00:00

  • Evaluation of adverse effects of vaccines: the case-control approach.

    abstract::When the hypothesis of a link between vaccination and a possible adverse outcome arises, further investigation is required to confirm or refute the suspicion. Given the rarity of most serious adverse effects, a case-control approach will often be chosen. This paper discusses aspects of the design, analysis and interpr...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(02)00147-0

    authors: Smeeth L,Rodrigues LC,Hall AJ,Fombonne E,Smith PG

    更新日期:2002-06-07 00:00:00

  • Formulation of botulinum neurotoxin heavy chain fragments for vaccine development: mechanisms of adsorption to an aluminum-containing adjuvant.

    abstract::Heavy chain fragments of botulinum neurotoxin serotypes A and B are being developed as a bivalent vaccine for botulism. To potentiate the immune response, an aluminum containing adjuvant will be formulated with the two antigens. The adsorption mechanisms of each antigen to aluminum phosphate and aluminum hydroxide adj...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2005.03.028

    authors: DePaz RA,Henderson I,Advant SJ

    更新日期:2005-07-01 00:00:00

  • Sampling methods for the study of pneumococcal carriage: a systematic review.

    abstract::Streptococcus pneumoniae is an important pathogen worldwide. Accurate sampling of S. pneumoniae carriage is central to surveillance studies before and following conjugate vaccination programmes to combat pneumococcal disease. Any bias introduced during sampling will affect downstream recovery and typing. Many variable...

    journal_title:Vaccine

    pub_type: 杂志文章,评审

    doi:10.1016/j.vaccine.2012.08.080

    authors: Gladstone RA,Jefferies JM,Faust SN,Clarke SC

    更新日期:2012-11-06 00:00:00

  • Innate immunemodulator containing adjuvant formulated HA based vaccine protects mice from lethal infection of highly pathogenic avian influenza H5N1 virus.

    abstract::The highly pathogenic avian influenza (HPAI) H5N1 viruses and their spillover into the human population pose substantial economic and public health threats. Although antiviral drugs have some effect in treating influenza infection, vaccination is still the most effective intervention to prevent possible pandemic outbr...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2020.01.051

    authors: Lu Y,Landreth S,Liu G,Brownlie R,Gaba A,Littel-van den Hurk SVD,Gerdts V,Zhou Y

    更新日期:2020-02-28 00:00:00

  • Structural analysis and immunogenicity of recombinant major envelope protein (rA27L) of buffalopox virus, a zoonotic Indian vaccinia-like virus.

    abstract::Buffalopox virus (BPXV), an Indian variant of vaccinia virus (VACV), is a zoonotic agent and affects buffaloes, cattle and humans. A27L is one of the conserved major immuno-dominant envelope proteins of orthopox viruses (OPVs) involved in viral entry/maturation and elicits neutralizing antibodies. In this study, the A...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2015.08.058

    authors: Kumar A,Yogisharadhya R,Bhanuprakash V,Venkatesan G,Shivachandra SB

    更新日期:2015-10-05 00:00:00

  • Protection against influenza virus infection by nasal vaccination in advance of sublethal irradiation.

    abstract::The effect of sublethal gamma-ray irradiation on the protection conferred by a nasal influenza vaccine was investigated in BALB/c mice. A radiation dose of 7 Gy was selected as the sublethal dose as this caused exacerbation of the influenza but was not lethal in the mouse model. Mice were irradiated 7 days before, on ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/s0264-410x(99)00553-8

    authors: Hasegawa H,Kadowaki S,Takahashi H,Iwasaki T,Tamura S,Kurata T

    更新日期:2000-05-22 00:00:00

  • A qualitative study of healthcare provider awareness and informational needs regarding the nine-valent HPV vaccine.

    abstract::The 9-valent Human Papillomavirus (HPV) vaccine, 9vHPV, was licensed in the U.S. in December, 2014. We assessed healthcare provider (HCP) awareness of the newly approved vaccine and identified questions HCPs have about the vaccine. As part of a larger study, we used semi-structured interviews to ask 22 pediatric HCPs ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2016.01.050

    authors: Kasting ML,Wilson S,Dixon BE,Downs SM,Kulkarni A,Zimet GD

    更新日期:2016-03-08 00:00:00

  • Characterization of a novel live attenuated infectious bronchitis virus vaccine candidate derived from a Korean nephropathogenic strain.

    abstract::A nephropathogenic K2/01 strain of infectious bronchitis virus (IBV) was attenuated by 170 serial passages in embryonated chicken eggs for possible use as a future IBV vaccine strain. High-growth properties and narrow tissue tropisms (limited replication in respiratory tracts) were achieved by the adaptation process. ...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2010.01.062

    authors: Lee HJ,Youn HN,Kwon JS,Lee YJ,Kim JH,Lee JB,Park SY,Choi IS,Song CS

    更新日期:2010-04-01 00:00:00

  • Immune responses in Balb/c mice induced by a candidate SARS-CoV inactivated vaccine prepared from F69 strain.

    abstract::The immunogenicity of a candidate-inactivated vaccine prepared from SARS-CoV F69 strain was evaluated in Balb/c mice. Potent humoral immune responses were induced under the elicitation of three times of immunizations at 2-week intervals with this vaccine, combined with three types of adjuvants (Freund's adjuvant, Al(O...

    journal_title:Vaccine

    pub_type: 杂志文章

    doi:10.1016/j.vaccine.2004.11.073

    authors: Zhang CH,Lu JH,Wang YF,Zheng HY,Xiong S,Zhang MY,Liu XJ,Li JX,Wan ZY,Yan XG,Qi SY,Cui Z,Zhang B

    更新日期:2005-05-02 00:00:00