This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.
Study Type
OBSERVATIONAL
Enrollment
486
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan, China
Geometric Mean Titer of Neutralizing Antibodies Against HPV-16
Serum HPV-16 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Time frame: At Months 42 and 66 after the first dose in the base study
Geometric Mean Titer of Neutralizing Antibodies Against HPV-18
Serum HPV-18 neutralizing antibody titers are measured using a high-throughput pseudovirus-based neutralization assay. The geometric mean titer and 95% confidence interval are summarized overall and by exposure cohort at each time point.
Time frame: At Months 42 and 66 after the first dose in the base study
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-16
The percentage of participants with an HPV-16 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
Time frame: At Months 42 and 66 after the first dose in the base study
Percentage of Participants Seropositive for Neutralizing Antibodies Against HPV-18
The percentage of participants with an HPV-18 neutralizing antibody titer at or above the assay cutoff specified in the statistical analysis plan is summarized with an exact 95% confidence interval at each time point.
Time frame: At Months 42 and 66 after the first dose in the base study
Number and Percentage of Participants With HPV-16- and/or HPV-18-Related CIN2+ Breakthrough Cases
A breakthrough case is defined as cervical histopathology showing CIN2, CIN3, adenocarcinoma in situ, or cervical cancer, with HPV DNA testing of the cervical tissue positive for HPV-16 and/or HPV-18. The number and percentage of participants with a breakthrough case are summarized overall and by exposure cohort.
Time frame: From the first dose in the base study through Month 66 after the first dose
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