Simultaneous Quantitation of Antibodies to Neutralizing Epitopes on Virus-Like Particles for Human Papillomavirus Types 6, 11, 16, and 18 by a Multiplexed Luminex Assay

Opalka, David; Lachman, Charles E.; MacMullen, Stefani A.; Jansen, Kathrin U.; Smith, Jessica A.; Chirmule, Narendra; Esser, Mark T.

doi:10.1128/cdli.10.1.108-115.2003

Cited by 257 publications

(232 citation statements)

References 49 publications

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“…About 90 samples were selected for each single year of age in the range 10 -19 years, and about 60 samples for each of the ages 20 -29 years. Samples were tested for specific neutralising antibodies to HPV 6, 11, 16 and 18 by Merck and Co Inc., using a multiplexed competitive Luminex s assay with antibody levels reported in milli-Merck units per millilitre (mMu ml À1 ) as previously described (Opalka et al, 2003). Titres were calibrated to ensure comparability with other published work using the same assay (calibration factors provided by Mark Esser, personal communication).…”

Section: Methodsmentioning

confidence: 99%

Prevalence of human papillomavirus antibodies in young female subjects in England

Jit

Vyse²,

Borrow³

et al. 2007

Br J Cancer

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Sera from 1483 female subjects in England aged 10 -29 years were tested. The age-standardised seroprevalence was 10.7% (95% confidence intervals 9.0 -12.3) for human papillomavirus (HPV) 6, 2.7% (1.8 -3.6) for HPV 11, 11.9% (10.2 -13.6) for HPV 16, 4.7% (3.5 -5.8) for HPV 18, Infection with human papillomavirus (HPV) types identified as 'high-risk' is a pre-requisite for developing cervical cancer (Munoz et al, 2003). HPV types 16 and 18 are associated with 70% of cervical cancers worldwide (Munoz et al, 2003), while HPV types 6 and 11, although not 'high-risk', are associated with over 90% of cases of anogenital warts (von Krogh et al, 2001). Two prophylactic vaccines against HPV (a bivalent vaccine against types 16 and 18, and a quadrivalent vaccine that also includes types 6 and 11) have been shown in clinical trials to reduce persistent HPV infection and associated disease by over 90% in up to 5 years of follow-up (Harper et al, 2004;Villa et al, 2006).Epidemiological knowledge of HPV infection in the UK relies heavily on prevalence studies of HPV DNA in the cervical epithelium of women undergoing cervical sampling (Woodman et al, 2001;Kitchener et al, 2006) and usually relates to female subjects known to be sexually active. These studies indicate the prevalence of current infection, as most HPV infections are transient and become DNA negative within 2 years (Moscicki et al, 2006). In individuals who mount a detectable humoral immune response, HPV type-specific serum antibodies are an indicator of past exposure. Testing of blood samples also offers the opportunity to survey different populations.Enzyme-linked immunosorbent assays (ELISAs) utilising viruslike particles have been used successfully for seroprevalence studies in several countries including the USA (Stone et al, 2002) and Sweden (af Geijersstam et al, 1999). We report on the first population-based study of HPV 6, 11, 16 and 18 seroprevalence in England, in 10-to 29-year-old female subjects -the likely target age range for vaccination, but an age range in which little is known about infection rates. MATERIALS AND METHODSSerum specimens were obtained from the Health Protection Agency Sero-Epidemiology Unit collection, consisting of unlinked residual sera submitted to laboratories in England for routine microbiological or biochemical investigations. Sera from immunocompromised individuals and repeat sera from the same individuals were excluded (Osborne et al, 2000).Sera were selected from 1483 women aged 10 -29 years, chosen as most important for informing the design of HPV vaccination programmes in the UK. Sera came from 11 laboratories in England that collected samples in 2002 -2004. About 90 samples were selected for each single year of age in the range 10 -19 years, and about 60 samples for each of the ages 20 -29 years. Samples were tested for specific neutralising antibodies to HPV 6, 11, 16 and 18 by Merck and Co Inc., using a multiplexed competitive Luminex s assay with antibody levels reported in milli-Merck units per millilitre (mMu ml À1 ...

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Section: Methodsmentioning

confidence: 99%

Prevalence of human papillomavirus antibodies in young female subjects in England

Jit

Vyse²,

Borrow³

et al. 2007

Br J Cancer

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“…With a few exceptions [18,20], these assays have not been directly compared. L1 VLP-based ELISA has been extensively used in studies of HPV epidemiology and vaccinology [6,19,[21][22][23][24].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of systemic and mucosal anti-HPV16 and anti-HPV18 antibody responses from vaccinated women

Kemp¹,

Garcı́a-Piñeres²,

Falk³

et al. 2008

Vaccine

106

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Ideal methods to monitor HPV neutralizing antibodies induced by vaccination have not been established yet. Here, we evaluated systemic and cervical antibody levels induced by HPV16/18 AS04-adjuvanted vaccine (GlaxoSmithKline Biologicals) using a secreted alkaline phosphatase neutralization assay (SEAP) and ELISA. Serum and cervical secretions from 50 vaccinated women were used to assess 1) overall assay reproducibility, 2) inter-assay and inter-specimen correlation; 3) correlations between month 1 and month 12 titers. Strong correlations between SEAP-NA and ELISA were observed (serum anti-HPV16/18, ρ=0.91/0.85; cervix anti-HPV16/18, ρ=0.84/0.89). Systemic and cervical antibody measures also correlated well (ρ range: 0.64 -0.75); except at mid-cycle (ρ range: 0.28 -0.65). Correlations between antibody levels at one and twelve months following the start of vaccination were poor (ρ range: 0.16 -0.38). In conclusion, HPV16/18 VLP-based ELISA is a reliable and valid method to monitor anti-HPV16/18 neutralizing potential for the first year following vaccination; however, additional studies will be Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.Conflict of Interest: Troy J. Kemp, no conflict; Alfonso García-Piñeres, no conflict; Roni T. Falk, no conflict; Sylviane Poncelet is employed by GSK Biologicals, the manufacturer of the vaccine used in this trial; Francis Dessy is employed by GSK Biologicals, the manufacturer of the vaccine used in this trial; Sandra L. Giannini is employed by GSK Biologicals, the manufacturer of the vaccine used in this trial; Ana Cecilia Rodriguez, no conflict; Carolina Porras, no conflict; Rolando Herrero, no conflict; Allan Hildesheim, no conflict; Ligia A. Pinto, no conflict. Merocel is a trademark of Medtronic Ophthalmics, a division of Medtronic Xomed, Inc., Jacksonville, FL, and Hemastix is a trademark of Bayer Corporation, Elkhart, IN. NIH Public Access Author ManuscriptVaccine. Author manuscript; available in PMC 2014 August 13.

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“…15). Dilutioncorrected serostatus cutoffs were 20 mMU/mL for HPV 6, 16 mMU/mL for HPV 11, 20 mMU/mL for HPV 16, and 24 mMU/mL for HPV 18.…”

Section: Clinical Follow-up and Case Definitionmentioning

confidence: 99%

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Kjær

Sigurðsson

Iversen

et al. 2009

Cancer Prevention Research

281

133

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Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

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Simultaneous Quantitation of Antibodies to Neutralizing Epitopes on Virus-Like Particles for Human Papillomavirus Types 6, 11, 16, and 18 by a Multiplexed Luminex Assay

Cited by 257 publications

References 49 publications

Prevalence of human papillomavirus antibodies in young female subjects in England

Prevalence of human papillomavirus antibodies in young female subjects in England

Evaluation of systemic and mucosal anti-HPV16 and anti-HPV18 antibody responses from vaccinated women

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

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