Minimum serum antibody levels associated with protection from human papillomavirus 16 (HPV 16) reinfection among placebo subjects

ABSTRACTWe report final event-driven analysis data on the immunogenicity and efficacy of the human papillomavirus 16 and 18 ((HPV-16/18) AS04-adjuvanted vaccine in young women aged 15 to 25 years from the PApilloma TRIal against Cancer In young Adults (PATRICIA). The total vaccinated cohort (TVC) included all randomized participants who received at least one vaccine dose (vaccine,n= 9,319; control,n= 9,325) at months 0, 1, and/or 6. The TVC-naive (vaccine,n= 5,822; control,n= 5,819) had no evidence of high-risk HPV infection at baseline, approximating adolescent girls targeted by most HPV vaccination programs. Mean follow-up was approximately 39 months after the first vaccine dose in each cohort. At baseline, 26% of women in the TVC had evidence of past and/or current HPV-16/18 infection. HPV-16 and HPV-18 antibody titers postvaccination tended to be higher among 15- to 17-year-olds than among 18- to 25-year-olds. In the TVC, vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 1 or greater (CIN1+), CIN2+, and CIN3+ associated with HPV-16/18 was 55.5% (96.1% confidence interval [CI], 43.2, 65.3), 52.8% (37.5, 64.7), and 33.6% (−1.1, 56.9). VE against CIN1+, CIN2+, and CIN3+ irrespective of HPV DNA was 21.7% (10.7, 31.4), 30.4% (16.4, 42.1), and 33.4% (9.1, 51.5) and was consistently significant only in 15- to 17-year-old women (27.4% [10.8, 40.9], 41.8% [22.3, 56.7], and 55.8% [19.2, 76.9]). In the TVC-naive, VE against CIN1+, CIN2+, and CIN3+ associated with HPV-16/18 was 96.5% (89.0, 99.4), 98.4% (90.4, 100), and 100% (64.7, 100), and irrespective of HPV DNA it was 50.1% (35.9, 61.4), 70.2% (54.7, 80.9), and 87.0% (54.9, 97.7). VE against 12-month persistent infection with HPV-16/18 was 89.9% (84.0, 94.0), and that against HPV-31/33/45/51 was 49.0% (34.7, 60.3). In conclusion, vaccinating adolescents before sexual debut has a substantial impact on the overall incidence of high-grade cervical abnormalities, and catch-up vaccination up to 18 years of age is most likely effective. (This study has been registered atClinicalTrials.govunder registration no. NCT001226810.)

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Serologic response to human papillomavirus 16 among Australian women with high-grade cervical intraepithelial neoplasia

International Journal of Gynecological Cancer ◽

10.1136/ijgc-00009577-200605000-00013 ◽

2006 ◽

Vol 16 (3) ◽

pp. 1032-1035

Author(s):

S. N. Tabrizi ◽

I. H. Frazer ◽

S. M. Garland

Keyword(s):

Human Papillomavirus ◽

Cervical Intraepithelial Neoplasia ◽

Intraepithelial Neoplasia ◽

High Grade ◽

Hpv 16 ◽

Hpv Dna ◽

Human Papillomavirus 16 ◽

Serologic Response ◽

Poor Predictor ◽

Hpv Types

This study evaluated the detection of human papillomavirus (HPV) 16 antibody in HPV 16–associated cervical intraepithelial neoplasia (CIN) in Australian women. Seroreactivity to HPV 16 L1 virus–like particles was assessed in patients with CIN 2 (n = 169) and CIN 3 (n = 229) lesions previously tested for the presence of HPV DNA. Seropositivity was significantly commoner in women with HPV 16 DNA–positive lesions (98/184) than in women with no HPV DNA in the lesion (15/47) or with HPV of types other than 16 in the lesion (43/167) (P = 0.0004). In addition, seropositivity was observed in 33% (55/169) of women with CIN 2 and 46% (106/229) of women with CIN 3, in keeping with the lower fraction of CIN 2 (57/169) than CIN 3 (127/229) biopsies positive for HPV 16 DNA. HPV 16 seropositivity is most common in women with HPV 16–associated CIN, but many patients with HPV-associated CIN 3 are seronegative, and HPV 16 seropositivity is common in women with CIN associated with other HPV types. Overall, HPV 16 serology is a poor predictor of presence of HPV 16–associated CIN 3 in patient population studied.

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A Study of HB-201 Alone or in Combination With a Checkpoint Inhibitor in Patients With Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers'

Case Medical Research ◽

10.31525/ct1-nct04180215 ◽

2019 ◽

Author(s):

Keyword(s):

Human Papillomavirus ◽

Checkpoint Inhibitor ◽

Hpv 16 ◽

Human Papillomavirus 16

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A New Photoelectrochemical Biosensor based on FeOOH and Exonuclease III-aided Dual Recycling Signal Amplification for HPV-16 Detection

Chemical Communications ◽

10.1039/d1cc00756d ◽

2021 ◽

Author(s):

Yanlin Wang ◽

Lingying Xia ◽

Xuelian Xiang ◽

Ruo Yuan ◽

Shangping Wei

Keyword(s):

Human Papillomavirus ◽

Signal Amplification ◽

Iron Oxyhydroxide ◽

Hpv 16 ◽

Exonuclease Iii ◽

Human Papillomavirus 16 ◽

Photoelectrochemical Biosensor ◽

Exo Iii

Herein, based on iron oxyhydroxide (FeOOH) as the photoactive material and exonuclease III (Exo III)-aided dual recycling signal amplification, a new photoelectrochemical (PEC) biosensor was successfully developed for human papillomavirus-16...

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Head and neck cancer association to CIAP-2 expression due to human papillomavirus-16 (HPV-16) infection

Egyptian Journal of Biochemistry and Molecular Biology ◽

10.4314/ejbmb.v29i2.72443 ◽

2011 ◽

Vol 29 (2) ◽

Cited By ~ 1

Author(s):

A Mansour ◽

H Helmy ◽

M Ali ◽

S Kassim

Keyword(s):

Head And Neck Cancer ◽

Human Papillomavirus ◽

Head And Neck ◽

Neck Cancer ◽

Hpv 16 ◽

Human Papillomavirus 16

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Prediction of Human Papillomavirus 16 E6 Gene Expression and Cervical Intraepithelial Neoplasia Progression by Methylation Status

International Journal of Gynecological Cancer ◽

10.1111/igc.0b013e31819d8a5c ◽

2009 ◽

Vol 19 (3) ◽

pp. 321-325 ◽

Cited By ~ 30

Author(s):

Pavla Hublarova ◽

Roman Hrstka ◽

Pavla Rotterova ◽

Leopold Rotter ◽

Marie Coupkova ◽

...

Keyword(s):

Cervical Cancer ◽

Human Papillomavirus ◽

Cervical Intraepithelial Neoplasia ◽

Methylation Status ◽

Gene Promoter ◽

Intraepithelial Neoplasia ◽

Hpv 16 ◽

Human Papillomavirus 16 ◽

E6 Gene ◽

Asymptomatic Women

Introduction:Human papillomavirus (HPV) infection represents the most important risk factor for the development of cervical intraepithelial neoplasia (CIN) and cervical cancer. We aimed to analyze the consequences of methylation of the E6 gene promoter in distinct stages of HPV-16-induced cellular transformation to assess its importance for disease progression.Methods:Human papillomavirus 16 was detected by sensitive polymerase chain reaction (PCR). Determination of E6 gene promoter methylation was analyzed by digestion with specific restriction endonuclease McrBC followed by PCR amplification. Expression of the E6 gene was determined by quantitative real-time PCR.Results:Of 103 cervical smears from asymptomatic women with no cytological and colposcopic abnormalities, 20.4% were HPV-16-positive. Human papillomavirus 16 was present in 44.4% of 18 patients with CIN I, in 62.2% of 143 patients with CIN II/III, and in 74.2% of 31 cervix carcinoma specimens. The incidence of HPV-16 in all lesions compared with asymptomatic women was statistically significant (P< 0.001, Pearsonχ2test). Methylation was detected in 81% (n = 21) of HPV-16-positive asymptomatic smears compared with 62.5% in CIN I (n = 8), 31.5% (n = 89) in CIN II/III, and 43.4% (n = 23) in carcinomas; a statistical significance between lesions and healthy women was found (P< 0.001, Pearsonχ2test). Expression of E6 mRNA correlated with methylation status (P= 0.010, Mann-WhitneyUtest).Conclusions:We conclude that methylation of the E6 gene promoter in HPV-16 genome is a predictive biomarker for cervical cancer progression by regulating the expression of the E6 oncogene.

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