Human Papillomavirus Infection
Conditions
Keywords
Bivalent HPV vaccine, Immune persistence, Neutralizing antibody, Two-dose vaccination schedule, Long-term follow-up, Pichia pastoris
Brief summary
This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.
Interventions
BIOLOGICALBivalent Human Papillomavirus Vaccine (Types 16 and 18, Pichia pastoris)
Each 0.5 mL dose contained 40 micrograms of HPV-16 L1 virus-like particles and 20 micrograms of HPV-18 L1 virus-like particles adsorbed to aluminum phosphate. The vaccine was administered only in the base study 311-HPV-1004; no study vaccine is administered in 311-HPV-1004-EXTEND.
Sponsors
Shanghai Zerun Biotechnology Co.,Ltd
Yuxi Zerun Biotechnology Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* The participant, and the participant's legal guardian when applicable, is able to understand the study information and voluntarily sign the informed consent form for the extension study. * In the investigator's judgment, the participant is able to comply with protocol requirements, including attending scheduled visits and responding to follow-up telephone contacts. * The participant was enrolled in study 311-HPV-1004 and completed blood collection at Day 0 and Months 7, 12, 24, and 36.
Exclusion criteria
* Receipt of any HPV vaccine other than the study vaccine during study 311-HPV-1004 or between completion of that study and enrollment in this extension study. * Use of an investigational or unregistered product, other than the study vaccine, during study 311-HPV-1004 or between completion of that study and enrollment in this extension study. * Seropositivity for both HPV-16 and HPV-18 antibodies at baseline in study 311-HPV-1004. * Long-term use of immunosuppressive agents or
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of HPV-16 Neutralizing Antibodies | Months 84, 108, and 132 after the first dose in the base study | The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay. |
| Geometric Mean Titer of HPV-18 Neutralizing Antibodies | Months 84, 108, and 132 after the first dose in the base study | The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers are summarized separately for each prior-vaccination cohort using the high-throughput pseudovirus-based neutralization assay. |
| Seropositivity Rate for HPV-16 Neutralizing Antibodies | Months 84, 108, and 132 after the first dose in the base study | The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort. |
| Seropositivity Rate for HPV-18 Neutralizing Antibodies | Months 84, 108, and 132 after the first dose in the base study | The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of HPV-16 Neutralizing Antibodies in Stored Serum Samples | Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study | The geometric mean and two-sided 95% confidence interval of HPV-16 neutralizing antibody titers measured using the high-throughput pseudovirus-based neutralization assay are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study. |
| Geometric Mean Titer of HPV-18 Neutralizing Antibodies in Stored Serum Samples | Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study | The geometric mean and two-sided 95% confidence interval of HPV-18 neutralizing antibody titers measured using the high-throughput pseudovirus-based neutralization assay are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study. |
| Seropositivity Rate for HPV-16 Neutralizing Antibodies in Stored Serum Samples | Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study | The percentage of participants meeting the assay-defined seropositivity threshold for HPV-16 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study. |
| Seropositivity Rate for HPV-18 Neutralizing Antibodies in Stored Serum Samples | Before the first dose on Day 0 and at Months 7, 12, 24, and 36 after the first dose in the base study | The percentage of participants meeting the assay-defined seropositivity threshold for HPV-18 neutralizing antibodies and its exact two-sided 95% confidence interval are summarized separately for each prior-vaccination cohort using available stored serum samples collected in the base study from participants who subsequently enrolled in the long-term extension study. |
Countries
China
Outcome results
None listed