Shanghai BOWEI BIOMEDICAL CO., LTD

Noninvasive self-sampling is a convenient option that may be highly accepted by women for home-based detection, which could increase the screening rate for cervical cancer (CC) and reduce its incidence and mortality.

To compare the distribution of high-risk human papillomavirus (hr-HPV) between the vulva and cervix and to explore the clinical value of vulvar HPV detection in CC screening.

The study was nested within a clinical trial on a recombinant HPV 9–valent vaccine for women ages 20 to 45 years. Women with paired vulvar and cervical specimens were included and underwent cytology and HPV detection. The consistency of HPV detection between vulvar and cervical specimens was evaluated using Cohen κ statistics. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were used to evaluate the diagnostic accuracy of primary CC screening. The primary end points were cervical intraepithelial neoplasia (CIN) grade 2/3 or worse (CIN2+/3+).

A total of 7999 women were enrolled, and 83/33 cases were diagnosed as CIN2+/CIN3+. The HPV-positive rate in vulvar specimens (1785 of 7999; 22.32%) was higher than that in cervical specimens (1390 of 7999; 17.38%), and there were no significant differences in the distribution of hr-HPV genotypes between the vulva and cervix in patients with CIN2+/CIN3+. Vulva-based HPV primary screening showed sensitivity, specificity, PPV, and NPV comparable to those for cervix-based HPV primary CC screening in the detection of CIN3+.

The distribution of vulvar and cervical HPV was similar in patients with CIN2+/CIN3+. Vulva-based HPV primary CC screening had acceptable diagnostic efficacy and might be used as a modality for primary CC screening.

Human papillomavirus (HPV) infections were the main cause of anogenital cancers and warts. HPV 6/11/16/18 vaccines provide protection against the high-risk types of HPV responsible for 70% of cervical cancers and 90% of genital warts. This randomized, blinded, non-inferiority phase III trial was to determine whether immunogenicity and tolerability would be non-inferior among women after receiving two novel 4- and 9-valent HPV vaccines (4vHPV, HPV 6/11/16/18; 9vHPV, HPV 6/11/16/18/31/33/45/52/58) compared with those receiving Gardasil 4 (4-valent).

1680 females between 20 and 45 years were randomized in a 2:1:1 ratio to 20-26, 27-35, or 36-45 y groups. Subjects then equally assigned to receive 4vHPV, 9vHPV or Gardasil 4 (control) vaccine at months 0, 2, and 6. End points included non-inferiority of HPV-6/11/16/18 antibodies for 4vHPV versus control, and 9vHPV versus control and safety. The immunogenicity non-inferiority was pre-defined as the lower bound of 95% confidence interval (CI) of seroconversion rate (SCR) difference > -10% and the lower bound of 95% CI of geometric mean antibody titer (GMT) ratio > 0.5.

Among the three vaccine groups, more than 99% of the participants seroconverted to all 4 HPV types. The pre-specified statistical non-inferiority criterion for the immunogenicity hypothesis was met: all the lower bounds of 95% CIs on SCR differences exceeded -10% for each vaccine HPV type and the corresponding lower bounds of 95% CIs for GMT ratios > 0.5. Across vaccination groups, the most common vaccination reaction were injection-site adverse events (AEs), including pain, swelling, and redness. General and serious AEs were similar in the three groups. There were no deaths.

This study demonstrated that the novel 4- and 9-valent HPV vaccination was highly immunogenic and generally well tolerated, both of which were non-inferior to Gardasil 4 in immunogenicity and safety.

Objective:To establish a UPLC-MS method to determine the content of 3-(N-morpholine)propane sulfonic acid(MOPS)in recombinant human papillomavirus.Methods:Waters ACQUITY UPLC BEH HILIC column was used with the chromatog. method was as follows:20 mmol·L∼(-1) ammonium acetate and acetonitrile were adopted as mobile phase with gradient elution at 0.5 mL·min∼(-1) of the flow rate;the injection volume at 1.0 μL,the column temperature at 40 °C,and SIR neg. scanning mode with a mass number of 208 for the Qda detector.The tapered hole voltage was 15 V.Results:The resolution product by UPLC-QDa of HPV bulk and HPV-9 vaccine was 3.86 and 2.76,resp.The linear concentration of MOPS ranged from 0.009 765 6 μg·g∼(-1) to 20μg·g∼(-1)(r∼2=0.997 9).The quantition and detection limit were 0.009 765 6 μg·g∼(-1) and 0.004 882 8 μg·g∼(-1),resp.The RSD were below 2.0% in precision study.The average recovery of HPV bulk and HPV 9 vaccine were 99.4% and 100.6%,resp.Mops in samples was not detected.Conclusion:The method is simple,rapid,accurate,and with high resolution and repeatability.It could be applicable for determining the MOPS content of HPV bulk and HPV vaccine product.