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

Xiamen University

Status and phase: Completed; Phase 2

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Biological: 60μg HPV; Biological: 30μg HPV; Biological: 90μg HPV; Biological: Hepatitis B vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01356823

HPV-PRO-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,600 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent from the subject prior to enrolment;
• Female between, and including, 18 and 25 years of age at the time of enrolment;
• Subjects must be free of obvious health problems;
• Not pregnant and having no plan for pregnancy;

Exclusion criteria

• Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
• Previous vaccination against HPV;
• Having severe allergic history or other immunodeficiency;
• Chemotherapy and other immunosuppressive agents using;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,600 participants in 4 patient groups, including a placebo group

30μg HPV

Experimental group

Description:

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

Treatment:

Biological: 30μg HPV

60μg HPV

Experimental group

Description:

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

Treatment:

Biological: 60μg HPV

90μg HPV

Experimental group

Description:

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

Treatment:

Biological: 90μg HPV

hepatitis B vaccine

Placebo Comparator group

Description:

Participants in this arm would receive hepatitis B vaccine.

Treatment:

Biological: Hepatitis B vaccine