Cervical Cancer, Cervical Intraepithelial Neoplasia, Persistent Infection, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia
Conditions
Keywords
Durability of Protection, Human Papillomavirus 16, Human Papillomavirus 18, vaccine, females
Brief summary
The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.
Detailed description
This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study on Hebei Province before and to evaluate the durability of protection of the bivalent HPV vaccine on 90m and 114m after dose 1.
Interventions
The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant
Sponsors
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Jun Zhang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to 54 Years
Inclusion criteria
1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose; 2. Participants can fully understand the study content and sign an informed consent form； 3. Able to comply with the requests of the study;
Exclusion criteria
1. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study. 2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1 | expected 2-3 years | To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1 |
| Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1 | expected 2-3 years | To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects |
Countries
China
Contacts
Primary ContactChao Zhao, Doctor
Outcome results
None listed