Infections

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Papilloma

Uterine Cervical Neoplasms

Communicable Diseases

Virus Diseases

Persistent Infection

Carcinoma

Carcinoma in Situ

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Disease Attributes

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Gastrointestinal Agents

Vaccines

Aluminum Hydroxide

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

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

Ting Wu, Ph. D.

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

Xiamen Innovax Biotech Co., Ltd

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Jun Zhang

Professor

Wounds and Injuries

Burns

Bowen's Disease

Squamous Intraepithelial Lesions of the Cervix

Patients with squamous intraepithelial lesions of the lower anogenital tracts will receive laser ablation.

Laser ablation will be done for the squamous intraepithelial lesions of the lower anogenital tracts.

laser ablation

Shuang Li, Doctor

Dongli Kong, Doctor

Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.

This study focus on diseases of the female reproductive system.

Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions

Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions

No squamous intraepithelial lesions found by pathological examinations.

Tongji Hospital

Digestive System Diseases

Hepatitis A

Hepatitis

Hepatitis E

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Aluminum sulfate

Immunologic Factors

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

Xiamen University

professor

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

Those with a previous history of cervical cancer or CIN before incident VaIN and those with VaIN detected concomitantly with cervical cancer or CIN for whom both vaginal biopsy and cervical specimens were available in our hospital were eligible.

HPV test and Pap Smear

Lan-Yan Yang, PhD

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+. The study will include three arms to complete the follow-up data for the previous cohort constructed, and prospectively recruit new subjects with the appropriate inclusion/excluding criteria in order to increase sample size of this study.

The long-term outcomes of patients with antecedent cervical intraepithelial neoplasia (CIN) were lacking. A systematic review published in 2008 identified no studies that met the review eligibility criteria for the prevalence of HPV types among vaginal precursors and cancers. Two sporadic studies containing 16 and 81 cases were reported in that review. Given that vaginal intraepithelial neoplasia (VAIN) post-hysterectomy for CIN is an uncommon disease which has a prevalence of being 1 to 6 %; it has the potential to progress to malignancy. Although the etiology of VAIN has not been as thoroughly investigated as that of CIN, evidence implicates that the human papillomavirus (HPV) as the probable carcinogenic agent for the onset and evolution of some VAIN and vaginal cancers.

This study will construct a longitudinal risk model of VaIN according to the HPVs distribution of cervix and vaginal for those had CIN2+.

Longitudinal HPV Pap in CIN and VAIN

Longitudinal Study of Human Papillomavirus (HPV) Genotyping and Pap Smear in Patients With Antecedent Cervical Intraepithelial Neoplasia (CIN) and Association With Vaginal Intraepithelial Neoplasia (VAIN)

time to developing CIN+ or VaIN+ from first CIN+ diagnosis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions	NCT05170620	Squamous Intrae... Laser Burn	laser ablation	16 Years -	Tongji Hospital
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
Longitudinal HPV Pap in CIN and VAIN	NCT05931354	Cervical Intrae... Hysterectomy Human Papilloma... Vaginal Intraep...	HPV test and Pa...	20 Years -	Chang Gung Memorial Hospital
Research of Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions	NCT05170620	Squamous Intrae... Laser Burn	laser ablation	16 Years -	Tongji Hospital

Spots Global Cancer Trial Database for vaginal intraepithelial neoplasia