Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Rare Diseases

Uterine Cervical Neoplasms

Virus Diseases

Papilloma

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Precancerous Conditions

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Participants in this arm would receive 30μg HPV vaccines which contains 20μg HPV 16 antigen and 10μg HPV 18 antigen

Participants in this arm would receive 60μg HPV vaccines which contains 40μg HPV 16 antigen and 20μg HPV 18 antigen

Participants in this arm would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

Participants in this arm would receive hepatitis B vaccine.

Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

30μg HPV

Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

60μg HPV

Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

90μg HPV

Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.

Hepatitis B vaccine

Jun Zhang, Master

Yuemei Hu, Bachelor

Ting Wu, Ph. D

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine expressed in E. coli.

The primary purpose of this study is to evaluate which dosage of the HPV vaccine can induce higher antibody and at the same time caused less adverse events.

The secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.

Totally 1600 healthy women of 18-25 years of age were enrolled. The participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. The women were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.

Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years

To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine	NCT01356823	Cervical Intrae... Cervical Cancer	30μg HPV 60μg HPV 90μg HPV Hepatitis B vac...	18 Years - 25 Years	Xiamen University
Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine	NCT01356823	Cervical Intrae... Cervical Cancer	30μg HPV 60μg HPV 90μg HPV Hepatitis B vac...	18 Years - 25 Years	Xiamen University

Spots Global Cancer Trial Database for 60μg hpv

Every month we try and update this database with for 60μg hpv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 60μg hpv

Every month we try and update this database with for 60μg hpv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 60μg hpv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.