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Uterine Cervical Diseases

Uterine Diseases

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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Cervical Intraepithelial Neoplasia

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Vaccines

Aluminum Hydroxide

Immunologic Factors

No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-17 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for long-term effectiveness evaluation.

No intervention was implemented in this study. Participants with no previous HPV vaccination history were recruited as the control group for long-term effectiveness evaluation.

No intervention was implemented in this study. Participants who have participated in the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) and were aged 9-26 years at the time of enrollment, and have received at least one dose of the vaccine were recruited as the vaccine group for immuno-persistence evaluation.

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.

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

No intervention

Ting Wu, Ph. D.

Jun Zhang, MSc

The primary objective of this study is to evaluate the protective efficacy against future infections of HPV types 16/18 or related diseases and immuno-persistence (type specific IgG antibody) of the bivalent HPV vaccine in young female populations aged 9-17 years.

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . This study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent HPV vaccine (Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) . By matching control groups according to factors such as age and education level, and through long-term follow-up, this research aims to elucidate the protective efficacy of the bivalent HPV vaccine against future infections of HPV types 16/18/31/33/45 or related diseases in young female populations aged 9-17 years. Additionally, the study will evaluate the persistence of vaccine-induced antibodies, investigate the potential for type replacement/competition phenomena post-vaccination and assess oral HPV infections in the cohort population.

Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

Long-term Effectiveness and Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Girls Aged 9-17 Years

To investigate the potential for type replacement/competition phenomena post-vaccination

To explore the incidence of transient and persistent oral HPV infections in vaccinated and unvaccinated populations

To evaluate the efficacy of the bivalent vaccine against this outcome

To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level 9 years after the first dose

Xiamen Innovax Biotech Co., Ltd

Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China

Xiamen University

professor

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine

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

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .The investigators will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 54 months after dose 1

Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)

Immuno-persistence Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level on 54 month after the dose 1

To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 54 month after the dose 1

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Jun Zhang

Professor

Digestive System Diseases

Hepatitis A

Hepatitis

Hepatitis E

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Aluminum sulfate

This dosage contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant

commercialized HEV vaccine which contains 30μg HEV antigen adsorbed in alum-adjuvant

HPV Vaccine

HEV vaccine

Jun Zhang, Master

Youlin Qiao, Ph.D

Ting Wu, Ph. D

This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.

Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

A Phase III Multicenter, Randomized, Double-Blind, Placebo(Hepatitis E Vaccine)Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant(E.Coli)Human Papillomavirus Bivalent Vaccine in Healthy Women

Histopathologically confirmed CIN2+ and/or VIN2+ and/or VaIN2+ associated with oncogenic HPV types (e.g. HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) detected within the lesional component of the tissue specimen (by PCR).

Ministry of Science and Technology of the People´s Republic of China

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.

Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.

Chao Zhao, Doctor

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.

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.

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

The Durability of Protection Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 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

To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls	NCT06243666	Cervical Intrae... Cervical Cancer Persistent Infe...	Recombinant Hum... No intervention Recombinant Hum...	18 Years -	Xiamen University
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)	NCT04704908	Cervical Intrae... Cervical Cancer Vaginal Intraep... Vulvar Intraepi... Persistent Infe...	Recombinant Hum...	14 Years - 32 Years	Xiamen University
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls	NCT06243666	Cervical Intrae... Cervical Cancer Persistent Infe...	Recombinant Hum... No intervention Recombinant Hum...	18 Years -	Xiamen University
Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine	NCT01735006	Cervical Intrae... Cervical Cancer Vaginal Intraep... Vulvar Intraepi... Persistent Infe...	HPV Vaccine HEV vaccine	18 Years - 45 Years	Xiamen University
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female	NCT04969445	Cervical Intrae... Cervical Cancer Vaginal Intraep... Vulvar Intraepi... Persistent Infe...	Recombinant Hum...	26 Years - 54 Years	Xiamen University
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)	NCT04704908	Cervical Intrae... Cervical Cancer Vaginal Intraep... Vulvar Intraepi... Persistent Infe...	Recombinant Hum...	14 Years - 32 Years	Xiamen University

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