The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the durability of protection and immuno-persistence of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.

Detailed Description
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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 before and to evaluate the durability of protection and immuno-persistence of the bivalent HPV vaccine on 90m and 114m after dose 1.

Official Title
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The Durability of Protection and Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years

Conditions
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Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection

Intervention / Treatment
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* Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Participants can fully understand the study content and sign an informed consent form； Able to comply with the requests of the study; Exclusion Criteria: Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study. 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;

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccine group<br>Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant. | Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)<br>* 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<br>* Other names: There is no other Intervention in this study;|
| Control group<br>Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | expected 2-3 years | 
| Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1 | To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects | expected 2-3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV16 and anti-HPV18 type-specific IgG antibody level on 90m and 114m after dose 1 | To detect the anti-HPV 16 and anti-HPV 18 seroconversion rates and geometric mean concentrations on 90m and 114m after dose 1 | expected 2-3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, females, Durability of Protection, Immuno-persistence, Human Papillomavirus 16, Human Papillomavirus 18