Mianyang Center for Disease Control and Prevention
Mianyang, Sichuan, China
NCT Number: NCT07833852
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.
Interested in participating?
Request Info12 year–34 year
Female
Observational
Mianyang, Sichuan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Historical exposure assigned in the base study: three intramuscular 0.5-mL doses at Months 0, 2, and 6.
Time frame: At Months 42 and 66 after the first dose in the base study
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
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
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
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: From the first dose in the base study through Month 66 after the first dose
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.
Shanghai Zerun Biotechnology Co.,Ltd
Industry
A Single-Center, Open-Label, Long-Term Extension Study to Evaluate Immune Persistence Following Vaccination With a Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) in Healthy Females Aged 9 to 30 Years at Enrollment in Study 311-HPV-1005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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