Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types

Roberts, Christine C.; Green, Tina; Hess, Erica; Matys, Katie; Brown, Martha; Haupt, Richard M.; Luxembourg, Alain; Vuocolo, Scott; Saah, Alfred J.; Antonello, Joseph

doi:10.4161/hv.29205

Cited by 60 publications

(49 citation statements)

References 15 publications

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“…Serum samples were obtained on day 1 and at months 7, 12, 24, and 30 from all subjects for anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 antibody testing by the 9-Valent competitive Luminex Immunoassay (cLIA) (17). A subject was defined to be anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, and anti-HPV 58 seropositive if the anti-HPV serum cLIA level was ≥ 30, ≥ 16, ≥ 20, ≥ 24, ≥ 10, ≥ 8, ≥ 8, SUMMARY: A 9-valent human papillomavirus (HPV 6 11 16 18 31 33 45 52 58) virus-like particle vaccine (9vHPV) has been proven highly efficacious in preventing anogenital diseases related to HPV, in a pivotal phase III study for women aged 16-26 years.…”

Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

et al. 2017

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Section: Methodsmentioning

confidence: 99%

Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

et al. 2017

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“…46 Participants were observed for 30 minutes after each vaccination for any immediate reaction. All subjects received a vaccination report card (VRC) at the day 1, month 2, and…”

Section: Assessmentmentioning

confidence: 99%

Immunogenicity and Safety of a 9-Valent HPV Vaccine

et al. 2015

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OBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years.METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be .0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored.RESULTS: At 4 weeks after dose 3, .99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/ 31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity.CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing genderneutral HPV vaccination programs in preadolescents and adolescents.WHAT'S KNOWN ON THIS SUBJECT: Prophylactic vaccination of young women 16 to 26 years of age with the 9-valent human papillomavirus (HPV)-like particle (9vHPV) vaccine prevents infection and disease with vaccine HPV types.WHAT THIS STUDY ADDS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementation of gender-neutral HPV vaccination programs in preadolescents and adolescents.

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“…Although the HPV-8 cLIA and HPV-9 cLIA are based on the same principles, they are different assays; therefore, no numerical comparison can be made between the results of the 2 assays. Moreover, since the HPV-8 cLIA and HPV-9 cLIA antibody titers to each HPV type are determined using type-specific monoclonal antibodies, 12 it is not possible to make a direct comparison of assay results across HPV types.…”

Section: Assessmentmentioning

confidence: 99%

“…In Studies 2 and 3, serum samples obtained at day 1 and months 3 and 7 were tested for anti-HPV6/11/16/18/31/33/45/52/58 by a 9-valent competitive Luminex immunoassay (HPV-9 cLIA). 12 Version 1 of the HPV-9 cLIA (representing the pre-validated assay 10 ) was used in these 2 studies. In Study 1, serum samples obtained at day 1 and month 7 were tested for anti-HPV6/11/16/18/31/45/52 by an 8-valent cLIA (HPV-8 cLIA), an assay similar to the HPV-9 cLIA but not testing for anti-HPV33.…”

Section: Assessmentmentioning

confidence: 99%

Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine

Luxembourg

Brown

Bouchard

et al. 2015

Human Vaccines & Immunotherapeutics

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Our objective was to develop a multivalent prophylactic HPV vaccine that protects against infection and disease caused by HPV16/18 (oncogenic types in existing prophylactic vaccines) plus additional oncogenic types by conducting 3 Phase II studies comparing the immunogenicity (i.e., anti-HPV6/11/16/18 geometric mean titers [GMT]) and safety of 7 vaccine candidates with the licensed quadrivalent HPV6/11/16/18 vaccine (qHPV vaccine) in young women ages 16-26. In the first study (Study 1), subjects received one of 3 dose formulations of an 8-valent HPV6/11/16/18/31/45/52/58 vaccine or qHPV vaccine (control). In Study 2, subjects received one of 3 dose formulations (termed low-, mid-, and high-dose formulations, respectively) of a 9-valent HPV6/11/16/18/31/33/45/52/58 vaccine (9vHPV vaccine) or qHPV vaccine (control). In Study 3, subjects concomitantly received qHPV vaccine plus 5-valent HPV31/33/45/52/58 or qHPV vaccine plus placebo (control). All vaccines were administered at day 1/month 2/month 6. In studies 1 and 3, anti-HPV6/ 11/16/18 GMTs at month 7 were non-inferior in the experimental arms compared with the control arm; however, there was a trend for lower antibody responses for all 4 HPV types. In Study 2, this immune interference was overcome with the mid-and high-dose formulations of the 9vHPV vaccine by increasing antigen and adjuvant doses. In all 3 studies, all vaccine candidates were strongly immunogenic with respect to HPV31/33/45/52/58 and were well tolerated. Based on the totality of the results, the middle dose formulation of the 9vHPV vaccine was selected for Phase III evaluation. Each 0.5mL dose contains 30mg/40mg/60mg/40mg/20mg/20mg/20mg/20mg/20mg of HPV6/11/16/18/31/33/45/52/58 viruslike particles, and 500mg of amorphous aluminum hydroxyphosphate sulfate adjuvant.ClinicalTrials.gov numbers NCT00260039, NCT00543543, and NCT00551187.

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Development of a human papillomavirus competitive luminex immunoassay for 9 HPV types

Cited by 60 publications

References 15 publications

Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

Immunogenicity and Safety of a 9-Valent HPV Vaccine

Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine

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